HYDROXI-FLEX IMPLANT— 510(k) K812321

Name: FDA 510(k) clearance K812321
Creator: U.S. Food and Drug Administration
Published: 1981-10-29

Substantially Equivalent

Impladent

FDA 510(k) clearance K812321 for HYDROXI-FLEX IMPLANT, Substantially Equivalent on 1981-10-29. Applicant: Impladent. Device class: 2.

Clearance details

Applicant: Impladent
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 1981-08-17
Decision date: 1981-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 Impladent

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K923310 — OSTEOGEN (HA RESORB)1995-05-31
K881662 — EXPANDED CLAIMES TO OSTEOGEN(R)1988-09-01
K843398 — OSTEOGEN1984-12-27
K792663 — FLEXI-CUP IMPLANT1980-01-09

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.