K253999
- 510(k) number
- K253999
- Device name
- 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
- Applicant
- Nobel Biocare AB SE
- Product code
- NHA — Abutment, Implant, Dental, Endosseous
- Decision date
- 2026-08-06
- Date received
- 2025-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K253999.pdf
Official FDA record: K253999
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.