ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13— 510(k) K071235
Substantially EquivalentZimmer Dental, Inc.
FDA 510(k) clearance K071235 for ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13, Substantially Equivalent on 2007-05-30. 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
- Special
- 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 →
Recalls naming K071235
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 K071235.
Data sourced from openFDA. This site is unofficial and independent of the FDA.