FDA 510(k) K253999: Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
Dental practices and labs that restore Nobel Biocare implants now have a new, fully cleared family of ASC, MUA, and healing abutments plus Omnigrip screws; owners and specialists should verify compatibility and update inventory or ordering templates before the next implant case.
Key points
- Device family cleared under 510(k) K253999 includes six abutment variants (ASC engaging/non-engaging, MUA ASC, conical-connection healing) and two Omnigrip titanium screws.
- Product code NHA, Class II, Regulation 872.3630—standard endosseous dental implant abutment pathway, indicating no novel clinical risk profile.
- Sponsor: Nobel Biocare AB; clearance labeled “substantially equivalent (Traditional),” allowing immediate U.S. commercialization.
- Action item for implant teams: confirm CAD/CAM library updates and prosthetic screw torque values match the new Omnigrip Clinical and Prosthetic screws.
Who should care
Read the original on openFDA Dental Devices
Full reporting and any paywall content live on accessdata.fda.gov. We summarize and score; we do not republish.
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