- HIGH
- Regulatory
- Tier 1
- Hard News
Robotic dental implant company gets FDA clearance for digital guided surgery
- Source
- Becker's Dental + DSO Review
- Author
- Ariana Portalatin
- Originally at
- beckersdental.com(opens in a new tab)
Summary and scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol. Not the original publisher.
Why it matters for dental
Neocis' new FDA clearance for pterygoid implant placement with its Yomi S robotic system expands the procedures U.S. dentists can perform under robotic guidance, potentially increasing case acceptance for full-arch and complex implant cases.
Key points
- 01
Neocis received FDA 510(k) clearance for the Yomi S robotic system and YomiPlan software to support pterygoid implant placement.
- 02
Neocis conducted a formal verification and validation program confirming the system maintains accuracy specifications for pterygoid procedures.
- 03
Human factors validation found the procedure safe and effective for trained dental professionals using only the user manual.
- 04
More than 125,000 implants have been placed with Yomi robotic assistance to date.
Who should care
- Owner
- Specialist
- DSO
Read the original
Becker's Dental + DSO Review
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