P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS— 510(k) K081005
Substantially EquivalentInstitut Straumann AG
FDA 510(k) clearance K081005 for P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS, Substantially Equivalent on 2008-05-02. Applicant: Institut Straumann AG. Device class: 2.
Clearance details
- Applicant
- Institut Straumann AG
- 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
- Special
- Location
- Andover, MA, US
Recent devices under product code NHA
view allMore clearances from Institut Straumann AG
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 →
Recalls naming K081005
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081005.
Data sourced from openFDA. This site is unofficial and independent of the FDA.