A patient asks whether "the robot" can place their implant. A rep offers a demo. A headline says a robot prepared a crown on its own. For a general dentist, the hard part is separating what is cleared for US patients from prototypes and press releases.
This is a map as of October 2026: what FDA has cleared, what trials show against guides and navigation, what is approved only abroad or still in research, how labs use automation, and what it means for your implant cases.
Key Takeaways
- FDA's 510(k) database lists 18 clearances to Neocis, maker of Yomi, from 2016 to 2025; every dental device named "robotic" belongs to that one company.
- In a 2026 network meta-analysis of 21 randomized trials, robots reduced apex deviation by 1.35 mm compared with freehand placement, against 0.93 mm for static guides and 0.90 mm for dynamic navigation.
- In a 40-patient trial, an autonomous robot beat dynamic navigation on angle (1.01° against 1.78°) but not on linear deviation, and took longer (21.5 against 14.3 minutes).
- China had approved at least five implant robots by 2024; none appears in FDA's 510(k) or De Novo databases.
- On veneer preps in one bench study, a robot was less accurate than an experienced prosthodontist (0.30 against 0.19 mm).
- Lab automation mostly means machines that change their own tools and materials, such as a mill with a 20-position tool changer, per Ivoclar.
Quick Answer
Cleared: one robot family is FDA cleared for dentistry, Neocis's Yomi, an arm that keeps the surgeon's drill on a CBCT-based implant plan. Proven: robots and other guided methods place implants closer to plan than freehand, but robot trials are few and measure accuracy, not long-term outcomes. Hype: autonomous dental robots for US patients; none is FDA cleared. In labs, automation means mills and printers that load themselves, not robots replacing technicians.
FDA 510(k) clearances issued to Neocis for Yomi and its planning software from December 2016 to October 2025; no other company in FDA's 510(k) database has a dental device named "robotic" (checked October 1, 2026).
What Has the FDA Actually Cleared?
FDA cleared the Neocis Guidance System, now sold as Yomi, in December 2016. The latest of the company's 18 clearances, for Yomi S, came on October 28, 2025 (K252376). FDA classifies Yomi as a class II dental stereotaxic instrument under 21 CFR 872.4120, the regulation for bone cutting instruments.
A robot that guides the surgeon
Per the Yomi S summary, the arm holds a standard dental drill, moves only when the surgeon applies force, and keeps drilling within a CBCT-based plan. It tracks the patient through a splint attached over stable teeth on the opposite side of the mouth or fixed to bone with screws. A 2022 clearance (K222049) added guided bone reduction (alveoplasty). Yomi S has an arm with 7 degrees of freedom instead of 6 and the same listed accuracy, under 1 mm RMS. Neocis claims 100,000 implants placed with Yomi "and counting."
What clearance does not tell you
A 510(k) means FDA found the device substantially equivalent to an earlier one. The Yomi S summary lists usability, biocompatibility, cleaning, electrical safety and software testing, but no clinical study. Dynamic navigation systems X-Guide (cleared 2015) and Navident (2016) share the classification; they track the handpiece on a screen but do not hold it.
| System or approach | What it does | US status (October 1, 2026) | Published evidence |
|---|---|---|---|
| Yomi and Yomi S (Neocis) | Arm keeps the surgeon's drill on the implant plan; bone reduction | FDA 510(k) cleared since 2016 | Clinical case series, such as 38 implants in 5 patients |
| Dynamic navigation (X-Guide, Navident) | Cameras track the handpiece; the surgeon follows a screen | FDA 510(k) cleared since 2015 | Many clinical studies |
| Autonomous implant robots (Yakebot, Remebot, others) | Robot drills and places the implant; the surgeon supervises | Approved in China; no FDA 510(k) or De Novo record | Case series; a randomized trial |
| Lupin Robotic System | Veneer preparation | Company says pending FDA and EU MDR approval | Prospective study, 12 patients |
| Perceptive robot | Crown preparation | Company says no 510(k) clearance, not for sale in the US | Company preprint, 6 patients |
Is Robot-Assisted Implant Placement More Accurate?
Accuracy studies superimpose a postoperative CBCT on the plan and measure the gap at the platform, at the apex and in angle.
| Freehand | Static guide | Dynamic navigation | Robot-assisted | |
|---|---|---|---|---|
| How the drill is guided | Eye and hand | Printed template with sleeves | Tracking on a screen, no physical constraint | Arm resists movement off the plan |
| Platform deviation reduced vs freehand, randomized trials (Wu, 2026) | Reference | 0.65 mm | 0.60 mm | 0.67 mm |
| Apex deviation reduced vs freehand | Reference | 0.93 mm | 0.90 mm | 1.35 mm |
| Angular deviation reduced vs freehand | Reference | 4.09° | 3.69° | 5.29° |
| Pooled deviation in clinical studies, platform / apex / angle (Khaohoen, 2024) | Not pooled | 1.11 mm / 1.44 mm / 3.58° (53 studies) | 1.18 mm / 1.36 mm / 3.51° (15 studies) | 0.81 mm / 0.77 mm / 1.71° (2 studies) |
| Added steps | None | Guide design and fabrication | Registration; steeper learning curve | Splint, CBCT, setup; longer surgery in one trial |
What the trials show
Wu and colleagues' 2026 network meta-analysis included only randomized trials: 21 studies, 956 participants, 1,632 implants. Robots ranked first and were significantly more accurate at the apex than static guides or dynamic navigation. A 2026 meta-analysis of 27 clinical studies pooled robotic deviations of 0.67 mm at the platform, 0.71 mm at the apex and 1.68°, with no significant difference by robot system (Jia et al.). For immediate implants, robots and dynamic navigation ranked highest, but analyses limited to higher-quality evidence suggested smaller differences between guided methods (Nava et al., 2026).
Yomi-specific data are smaller: in a single-arm series of 5 edentulous patients and 38 implants, mean deviation was 1.04 mm at the platform, 0.95 mm at the apex and 2.56°, with no adverse events (Bolding and Reebye, 2022).
Where the evidence is thin
- Study quality: in a 2025 review of 43 comparative studies, only 6 were at low risk of bias, most robot data came from lab models or single centers, and most robot studies used the autonomous Remebot. The authors called the absolute benefit modest, about 0.5 to 1 mm (Pisla et al.).
- Outcomes: complications, patient-reported outcomes, long-term maintenance and economic value are underreported next to geometric accuracy (Alghamdi et al., 2026).
- Time and cost: the same review says early adoption can add setup and verification time, and formal cost-effectiveness evidence is limited.
What About Autonomous Robots?
Autonomous implant robots: marketed in China
Chinese systems such as Yakebot and Remebot prepare the osteotomy and place the implant under the surgeon's supervision. A 2024 review lists five implant robots approved by China's National Medical Products Administration (Liu et al.). Published results include 10 single implants with mean deviations of 0.74 mm at the platform, 0.73 mm at the apex and 1.11° (Yang et al., 2023), and 102 full-arch implants in 12 patients with stable periodontal parameters at 1 year (Xie et al., 2024). In the 40-patient trial, the robot beat dynamic navigation only on angle and took about 7 minutes longer (Wei et al., 2025).
Robots that prepare teeth: investigational
On printed models, an automated full-crown system matched its planned prep more closely than a step-by-step guide (0.18 against 0.33 mm RMSE) and was faster (350 against 584 seconds) (Fang et al., 2026). In another bench study, a semi-active robot was less accurate on veneer preps than a prosthodontist working freehand (Li et al., 2025). In patients, the Lupin system prepared 52 teeth for veneers in 12 patients, with errors centered around 0.15 mm (More et al., 2025). Perceptive's crown robot, covered in Will AI Replace Dentists and Dental Technicians?, still lacks 510(k) clearance, per the company.
How Are Robots Used in Dental Labs?
Mills and printers that load themselves
Most lab automation is machines that keep working between jobs. Ivoclar lists a 20-position automatic tool changer and an 8-way material changer for up to 8 discs and 48 blocks for its PrograMill PM7. Amann Girrbach says its Ceramill Matik tracks 36 holders by RFID, cleans its own milling chamber and can process orders autonomously, even over the weekend. Formlabs says its Form Auto removes finished parts and starts the next print without an operator. These manufacturer claims describe automated loading and machining, not design decisions.
Robot arms, aligners and dentures
A 2026 review describes aligner robotics as industrial automation in production, trimming, finishing and quality checks, and values robotic archwire bending for manufacturing consistency (Alghamdi et al.). Robots that arrange denture teeth are still research: 8 of 18 studies in a 2025 scoping review, with clinical use described as early (Alqutaibi et al.).
What automation does not fix
The 2026 review warns that in a digital chain, planning errors "become accurately reproduced." A mill cuts a crown to a missed margin or a one-sided bite as precisely as to a good one, so the scan, bite and Rx you send matter more, not less.
What Does This Mean for Your Practice?
Questions to ask before you buy a robot or refer to one
- Which 510(k) number covers it, and for which indications?
- Are the accuracy claims backed by randomized trials or case series, and who funded them?
- What does it add per case (a splint before the CBCT, registration, setup), and how many cases until a new user is consistent?
- Can the plan be exported so the restorative dentist and the lab see the planned implant positions?
- What is the full cost per case, including disposables and service?
The restoration is still a lab case
No robot or guide designs the crown. A well-placed implant still needs a restorative plan before surgery and a scan or impression after it, and connection, abutment and material remain your and the lab's decisions; see Screw-Retained vs Cement-Retained Implant Crowns.
Implant Restorations at Elegant Dental Laboratory
- Every case is made in house in Brooklyn by more than 35 technicians; digital scans are reviewed before production.
- Implant restorations: screw-retained and cement-retained options, custom screw-retained abutments and full-arch, with design libraries for all major implant systems. We accept compatible scan bodies and titanium bases; scan bodies are available to practices.
- 5 business day standard turnaround on most restorative cases, rush options, up to a 7-year warranty on final restorations and up to 20 years on screw-retained implant abutments (policies and warranties).
- Submit a digital case (STL or PLY from all major scanners) or send a case: free pickup by our own drivers in all five boroughs and 13 northern New Jersey counties, UPS labels anywhere. Call 877-335-5221.
FAQ
Is there an FDA-cleared autonomous dental robot?
No. The only robotic dental systems in FDA's 510(k) database are Neocis's Yomi models, which guide the surgeon's hand. Autonomous implant robots are approved in China.
Is a robot more accurate than a surgical guide?
In randomized trials, robots ranked first and were more accurate at the apex, but every guided method beat freehand, and the differences between them are fractions of a millimeter.
Does a robot-placed implant need a different restoration?
No. The lab needs the same information: implant system, platform, connection and an accurate scan or impression.
Can a robot prepare a crown for a US patient?
Not outside research. Perceptive says its prototypes lack 510(k) clearance, and Lupin says its veneer robot is pending FDA approval.
Do dental labs use robots?
Mostly as mills and printers that change tools, materials or build plates automatically. Denture setup robots are still experimental.
Sources (27)
- US Food and Drug Administration. 510(k) Summary K252376, Yomi S Robotic System (Neocis), decision October 28, 2025. PDF
- US Food and Drug Administration. 510(k) Premarket Notification database: clearances to Neocis, Inc., 2016 to 2025 (openFDA query; data updated September 21, 2026). openFDA; first clearance K161399: FDA record
- US Food and Drug Administration. 510(k) Summary K222049, Yomi Robotic System (guided bone reduction), decision November 4, 2022. PDF
- US Food and Drug Administration. 510(k) records K150222 (X-Guide Surgical Navigation System) and K161406 (Navident). K150222, K161406
- US Food and Drug Administration. De Novo DEN250046, Aletta Autonomous Robotic Phlebotomy Device, granted August 19, 2026. FDA record
- Neocis. Yomi home page (company claims), accessed October 1, 2026. neocis.com
- Wu XY, et al. Accuracy of Implant Placement with Robotic Surgery, Dynamic Navigation, Fully Static Guide, and Freehand Surgery: A Systematic Review and Network Meta-analysis. Int J Oral Maxillofac Implants. 2026;41(5):567-576. doi:10.11607/jomi.11531
- Khaohoen A, et al. Accuracy of implant placement with computer-aided static, dynamic, and robot-assisted surgery: a systematic review and meta-analysis of clinical trials. BMC Oral Health. 2024;24(1):359. doi:10.1186/s12903-024-04033-y
- Jia J, et al. Accuracy of robotic computer-assisted implant surgery in clinical dental implant placement: A systematic review and meta-analysis. J Dent. 2026;166:106321. doi:10.1016/j.jdent.2025.106321
- Nava P, et al. Accuracy of Static, Dynamic, and Robotic Guided Surgery in Immediate Implant Placement: A Systematic Review and Network Meta-Analysis. Clin Oral Implants Res. 2026;37(5):525-542. doi:10.1111/clr.70100
- Bolding SL, Reebye UN. Accuracy of haptic robotic guidance of dental implant surgery for completely edentulous arches. J Prosthet Dent. 2022;128(4):639-647. doi:10.1016/j.prosdent.2020.12.048
- Pisla D, et al. Accuracy of Navigation and Robot-Assisted Systems for Dental Implant Placement: A Systematic Review. Dent J (Basel). 2025;13(11):537. doi:10.3390/dj13110537
- Alghamdi A, et al. Robot-Assisted Dentistry: What the Evidence Supports and Which Outcomes Are Still Missing. Cureus. 2026;18(5):e108601. doi:10.7759/cureus.108601
- Liu C, et al. The evolution of robotics: research and application progress of dental implant robotic systems. Int J Oral Sci. 2024;16(1):28. doi:10.1038/s41368-024-00296-x
- Yang S, et al. Accuracy of autonomous robotic surgery for single-tooth implant placement: A case series. J Dent. 2023;132:104451. doi:10.1016/j.jdent.2023.104451
- Xie R, et al. Clinical evaluation of autonomous robotic-assisted full-arch implant surgery: A 1-year prospective clinical study. Clin Oral Implants Res. 2024;35(4):443-453. doi:10.1111/clr.14243
- Wei H, et al. The Accuracy of Autonomous Robotic Surgery vs. Dynamic Navigation in Implant Placement: An Open-Label, Double-Arm, Randomized Controlled Clinical Trial. Clin Oral Implants Res. 2025;36(11):1486-1497. doi:10.1111/clr.70024
- Fang H, et al. Development and Evaluation of an Automated Robotic System for Full Crown Preparation. J Dent. 2026;167:106520. doi:10.1016/j.jdent.2026.106520
- Li Y, et al. Feasibility and accuracy of semi-active robot-assisted porcelain veneer tooth preparation: An in vitro study. J Dent. 2025;162:106012. doi:10.1016/j.jdent.2025.106012
- More V, et al. Safety and performance of the first supervised automated dental robot to perform minimally invasive tooth prep for laminate veneers. Int J Comput Dent. 2025, online ahead of print. doi:10.3290/j.ijcd.b6654641
- Lupin Dental. Home page (regulatory statement), accessed October 1, 2026. lupindental.com
- Perceptive. Home page (regulatory statements), accessed October 1, 2026. perceptive.io
- Ciriello C, et al. First in-human intervention using a semi-automated robot for tooth restorative treatment. Research Square preprint (Perceptive authors, not peer reviewed), 2025. doi:10.21203/rs.3.rs-6455412/v1
- Ivoclar. PrograMill PM7 product page (manufacturer specifications), accessed October 1, 2026. ivoclar.com
- Amann Girrbach. Ceramill Matik product page (manufacturer claims), accessed October 1, 2026. amanngirrbach.com
- Formlabs. Form Auto product page (manufacturer claims), accessed October 1, 2026. formlabs.com
- Alqutaibi AY, et al. Practical applications of robots in prosthodontics for tooth preparation and denture tooth arrangement: A scoping review. J Prosthet Dent. 2025;134(2):377.e1-377.e9. doi:10.1016/j.prosdent.2024.02.006
Reviewed by Gary Fingerman, founder and CEO of Elegant Dental Laboratory, Brooklyn, New York (founded 2007). Last reviewed: October 1, 2026. Regulatory status reflects FDA databases and company statements on that date; study values are from published research.
