ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM— 510(k) K071439
Substantially EquivalentZimmer Dental, Inc.
FDA 510(k) clearance K071439 for ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM, Substantially Equivalent on 2007-09-20. 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
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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 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.