ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM— 510(k) K141544
Substantially EquivalentZimmer Dental, Inc.
FDA 510(k) clearance K141544 for ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM, Substantially Equivalent on 2014-10-22. 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
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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.