REIGNING ARTIFICIAL TEETH— 510(k) K802492

Substantially Equivalent

Oki Shiks USA , Ltd.

FDA 510(k) clearance K802492 for REIGNING ARTIFICIAL TEETH, Substantially Equivalent on 1980-11-12. Applicant: Oki Shiks USA , Ltd.. Device class: 2.

Clearance details

Applicant: Oki Shiks USA , Ltd.
Product code: Code ELM
Device class: Class 2
Regulation: 21 CFR 872.3590
Advisory panel: Dental
Date received: 1980-10-10
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ELM

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K122955 — DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM2013-03-01
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K122852 — PHYSIOSTAR NFC2012-12-06
K121749 — VERACIA2012-09-07

More clearances from Oki Shiks USA , Ltd.

K821217 — REIGNING DENTURE1982-06-07
K802490 — REIGNING DENTURE1980-11-19
K802489 — REIGNING CROWN BRIDGE1980-11-12
K802491 — REIGNING REPAIR EPOXY RESIN1980-11-12
K801236 — REIGNING EPOXY RESIN CEMENT1980-07-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.