TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG— 510(k) K001786

Name: FDA 510(k) clearance K001786
Creator: U.S. Food and Drug Administration
Published: 2000-06-21

Substantially Equivalent

Sulzer Calcitek, Inc.

FDA 510(k) clearance K001786 for TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG, Substantially Equivalent on 2000-06-21. Applicant: Sulzer Calcitek, Inc.. Device class: 2.

Clearance details

Applicant: Sulzer Calcitek, Inc.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2000-06-13
Decision date: 2000-06-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

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K260463 — ZEROS Dental Implant System2026-08-19
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K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

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K982305 — SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT1998-09-22
K981562 — SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT1998-07-30
K973521 — VARIABLE PARALLEL PIN1997-11-20

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, 2020-01-01 through 2026-04-23. 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.