3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615— 510(k) K033430

Name: FDA 510(k) clearance K033430
Creator: U.S. Food and Drug Administration
Published: 2003-11-07

Substantially Equivalent

Implant Innovations, Inc.

FDA 510(k) clearance K033430 for 3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615, Substantially Equivalent on 2003-11-07. Applicant: Implant Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Implant Innovations, Inc.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2003-10-28
Decision date: 2003-11-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Palm Beach Gardens, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

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K250806 — Dental Implant System2026-06-18
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K260006 — INOSS System2026-06-17

More clearances from Implant Innovations, Inc.

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K062636 — OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS2007-06-01
K063341 — 3I OSSEOTITE CERTAIN DENTAL IMPLANTS2007-04-30
K063286 — OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE2007-04-24
K063403 — CONICAL ANGLED ABUTMENT2007-03-20
K061629 — CERTAIN PREVAIL DENTAL IMPLANT2007-02-23

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.