F-SERIES IMPLANT— 510(k) K850706

Name: FDA 510(k) clearance K850706
Creator: U.S. Food and Drug Administration
Published: 1985-04-10

Substantially Equivalent

Omni Intl., Inc.

FDA 510(k) clearance K850706 for F-SERIES IMPLANT, Substantially Equivalent on 1985-04-10. Applicant: Omni Intl., Inc.. Device class: 2.

Clearance details

Applicant: Omni Intl., Inc.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 1985-02-22
Decision date: 1985-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, 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 Omni Intl., Inc.

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K984066 — OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM1999-01-13
K984064 — OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE1999-01-08
K853255 — OMNIMED I.V. SOLUTION ADMIN. SET1985-08-23
K851938 — OMNIMED SURGICAL GOWN1985-06-28
K851654 — OMNIMED CLAMP1985-05-31

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.