MRI Compatibility for Existing Zimmer Dental Implant Systems— 510(k) K160398
Substantially EquivalentZimmer Dental, Inc.
FDA 510(k) clearance K160398 for MRI Compatibility for Existing Zimmer Dental Implant Systems, Substantially Equivalent on 2017-05-17. Applicant: Zimmer Dental, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer Dental, Inc.
- Product code
- Code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code DZE
view allMore clearances from Zimmer Dental, Inc.
view all- 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
- K141544 — ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM
Adverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
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.