Universal Base ASC Engaging +6 more— 510(k) K253999

Name: FDA 510(k) clearance K253999
Creator: U.S. Food and Drug Administration
Published: 2026-08-06

Substantially Equivalent

Nobel 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.

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: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2025-12-15
Decision date: 2026-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goteborg, SE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.