3I BIORESORBABLE FIXATION TACK— 510(k) K972480

Name: FDA 510(k) clearance K972480
Creator: U.S. Food and Drug Administration
Published: 1997-12-23

Substantially Equivalent

Implant Innovations, Inc.

FDA 510(k) clearance K972480 for 3I BIORESORBABLE FIXATION TACK, Substantially Equivalent on 1997-12-23. Applicant: Implant Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Implant Innovations, Inc.
Product code: Code DZL
Device class: Class 2
Regulation: 21 CFR 872.4880
Advisory panel: Dental
Date received: 1997-07-01
Decision date: 1997-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZL

view all

K254286 — Guided Bone Regeneration System2026-08-24
K250123 — Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)2025-09-29
K251569 — Bone Screw2025-08-13
K243190 — USTOMED Bone Fixation/Bone Augmentation Systems - PIN2025-06-27
K233419 — GBR System2025-01-03

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 DZL

product code DZL

Injury: 168
Total: 168

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.