SULZER DENTAL CERAMIC SYSTEM-SPLINE— 510(k) K014214

Name: FDA 510(k) clearance K014214
Creator: U.S. Food and Drug Administration
Published: 2002-03-19

Substantially Equivalent

Sulzer Dental, Inc.

FDA 510(k) clearance K014214 for SULZER DENTAL CERAMIC SYSTEM-SPLINE, Substantially Equivalent on 2002-03-19. Applicant: Sulzer Dental, Inc.. Device class: 2.

Clearance details

Applicant: Sulzer Dental, Inc.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2001-12-21
Decision date: 2002-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
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
K251188 — UNIQA® Dental Implants System2026-06-25
K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

More clearances from Sulzer Dental, Inc.

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K014050 — HEX-LOCK TEMPORARY ABUTMENT2002-11-13
K014175 — SULZER DENTAL CERAMIC SYSTEM-HEXLOCK2002-03-20
K013494 — 3.75MM AND 5.0MM SPLINE TWIST IMPLANT2002-01-18
K013227 — SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT2001-11-19
K012055 — 3.25MM SPLINE TWIST IMPLANT2001-09-06

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.