FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE— 510(k) K945847

Name: FDA 510(k) clearance K945847
Creator: U.S. Food and Drug Administration
Published: 1996-03-15

Substantially Equivalent

Friatec Medical Inc., USA

FDA 510(k) clearance K945847 for FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE, Substantially Equivalent on 1996-03-15. Applicant: Friatec Medical Inc., USA. Device class: 2.

Clearance details

Applicant: Friatec Medical Inc., USA
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 1994-11-30
Decision date: 1996-03-15
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 Medical Inc., USA

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K945848 — FRIALIT(R)-2 DENTAL IMPLANT1996-03-15
K945849 — FRIALIT(R)-2 STEPPED CYLINDER WITH FRIOS(R) TI-COATING1996-03-15
K934332 — SURGICAL INSTRUMENTS, FORCEPS & GRASPERS, PROBES & CURETTES1994-03-25

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.