OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED)— 510(k) K904228

Name: FDA 510(k) clearance K904228
Creator: U.S. Food and Drug Administration
Published: 1990-11-09

Substantially Equivalent

Collagen Corp.

FDA 510(k) clearance K904228 for OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED), Substantially Equivalent on 1990-11-09. Applicant: Collagen Corp.. Device class: 2.

Clearance details

Applicant: Collagen Corp.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 1990-08-14
Decision date: 1990-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, 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 Collagen Corp.

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K904671 — QAR HANDPIECE1990-12-21
K901600 — OSSEOTITE IRRIGATION UNIT1990-06-21
K900275 — OSSEODENT DENTAL ATTACHMENT, IGLOO MAGNET1990-04-19
K895462 — OSSEODENT DENTAL ATTACHMENTS1990-04-04
K895463 — OSSEODENT(R) PRECISION DENTAL ATTACHMENTS1990-03-28

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 →

Recalls naming K904228

K-number listed on FDA's recall record

Z-2438-2016 — Prep-tite Cap Dental implantsClass II·Terminated·Biomet 3i, LLC·20151125

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K904228.

Data sourced from openFDA. This site is unofficial and independent of the FDA.