FRIALIT-2 PROTECT ABUTMENT— 510(k) K974628

Name: FDA 510(k) clearance K974628
Creator: U.S. Food and Drug Administration
Published: 1998-03-11

Substantially Equivalent

Friatec AG

FDA 510(k) clearance K974628 for FRIALIT-2 PROTECT ABUTMENT, Substantially Equivalent on 1998-03-11. Applicant: Friatec AG. Device class: 2.

Clearance details

Applicant: Friatec AG
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 1997-12-11
Decision date: 1998-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Potomac, MD, 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 Friatec AG

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K982576 — FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, 45-24761998-10-22
K980630 — FRIALIT-2 CORABASE1998-09-04
K973924 — FRIOS BONESHIELD1998-05-07
K974358 — FRIALIT -2 SCREW1998-02-10
K974359 — FRIALIT-2 CYLINDER1998-02-10

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.