3I PATIENT-SPECIFIC OVERDENTURE BAR— 510(k) K034035

Name: FDA 510(k) clearance K034035
Creator: U.S. Food and Drug Administration
Published: 2004-03-24

Substantially Equivalent

Implant Innovations, Inc.

FDA 510(k) clearance K034035 for 3I PATIENT-SPECIFIC OVERDENTURE BAR, Substantially Equivalent on 2004-03-24. Applicant: Implant Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Implant Innovations, Inc.
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2003-12-29
Decision date: 2004-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NHA

view all

K253999 — Universal Base ASC Engaging +6 more2026-08-06
K261147 — Neodent Implant System - NeoConvert Fit2026-07-01
K261122 — MIST IC2026-06-27
K260061 — BioHorizons CEREC Compatible Ti-Bases2026-06-26
K253922 — Neodent Scannable Healing Abutment2026-06-15

More clearances from Implant Innovations, Inc.

view all

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 NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

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.