NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium— 510(k) K233208

Substantially Equivalent

Nobel Biocare AB

FDA 510(k) clearance K233208 for NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium, Substantially Equivalent on 2024-01-24. Applicant: Nobel Biocare AB. Device class: 2.

Clearance details

Applicant
Nobel Biocare AB
Product code
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
Download summary PDFView on FDA.gov ↗

Recent devices under product code NHA

view all

More clearances from Nobel Biocare AB

view all

Adverse 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.