Universal Base ASC Engaging +6 more— 510(k) K253999
Substantially EquivalentNobel Biocare AB
FDA 510(k) clearance K253999 for Universal Base ASC Engaging +6 more, Substantially Equivalent on 2026-08-06. Applicant: Nobel Biocare AB. Device class: 2.
Summary
Nobel Biocare's submission lists seven components, including Universal Base ASC (Engaging, Non-Engaging, and MUA versions), temporary and healing abutments, and Omnigrip clinical and prosthetic screws. The product code is NHA, endosseous dental implant abutments.
Class II, 21 CFR 872.3630. Dental is both the classification panel and the review panel. It came in as a Traditional 510(k).
Nobel Biocare filed from Goteborg, Sweden. The substantially equivalent decision came 234 calendar days after receipt (December 15, 2025 to August 6, 2026).
Clearance details
- Device name as filed
- 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
- Product code
- Product code NHA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3630
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goteborg, SE
Recent devices under product code NHA
view allMore clearances from Nobel Biocare AB
view allAdverse events under product code NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.