HEXLOCK— 510(k) K912262

Name: FDA 510(k) clearance K912262
Creator: U.S. Food and Drug Administration
Published: 1991-12-10

Substantially Equivalent

Imtec Corp.

FDA 510(k) clearance K912262 for HEXLOCK, Substantially Equivalent on 1991-12-10. Applicant: Imtec Corp.. Device class: 2.

Clearance details

Applicant: Imtec Corp.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 1991-05-22
Decision date: 1991-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ardmore, OK, 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 Imtec Corp.

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K081653 — MDI MII ONE-PIECE IMPLANT, 2.9MM2008-09-19
K081347 — ILUMA VISION2008-05-28
K072660 — ENDURE IMPLANT, MODEL 5108, 5111, 5113, 51142007-12-12
K053046 — ILUMA ORTHOCAT/DENTALCAT2005-11-08
K043226 — ENDURE IMPLANT, MODELS 3508, 4308, 3520, 43202005-01-13

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.