NOBELPROCERA OVERDENTURE BAR— 510(k) K132749
Substantially EquivalentNobel Biocare USA, LLC
FDA 510(k) clearance K132749 for NOBELPROCERA OVERDENTURE BAR, Substantially Equivalent on 2014-07-24. Applicant: Nobel Biocare USA, LLC. Device class: 2.
Clearance details
- Applicant
- Nobel Biocare USA, LLC
- 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
- Yorba Linda,, CA, US
Recent devices under product code NHA
view allMore clearances from Nobel Biocare USA, LLC
view all- K132746 — NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION
- K110171 — NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS
- K083100 — GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP
- K073142 — NOBELREPLACE HEXAGONAL IMPLANT
- K062566 — NOBELREPLACE TAPERED CONICAL CONNECTION
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.