ANGLED TAPERED ABUTMENT— 510(k) K111853
Substantially EquivalentZimmer Dental, Inc.
FDA 510(k) clearance K111853 for ANGLED TAPERED ABUTMENT, Substantially Equivalent on 2011-12-08. Applicant: Zimmer Dental, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer Dental, Inc.
- 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
- Carlsbad, CA, US
Recent devices under product code NHA
view allMore clearances from Zimmer Dental, Inc.
view all- K160398 — MRI Compatibility for Existing Zimmer Dental Implant Systems
- K143505 — Zimmer Patient-Specific Abutment, Internal Hex, Titanium
- K143528 — Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System
- K142572 — Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System
- K142082 — ZIMMER 3.1MM DENTAL IMPLANT; 2.9MM ANGLED ABUTMENT; STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT
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.