510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802492Substantially Equivalent

Reigning Artificial Teeth

Oki Shiks USA, Ltd., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802492 is the FDA 510(k) clearance record for REIGNING ARTIFICIAL TEETH, a class II device, cleared for Oki Shiks USA , Ltd. on under FDA product code ELM (Denture, Plastic, Teeth). FDA records list 9 510(k) clearances for Oki Shiks USA , Ltd., from to . As of , FDA records show no recalls naming K802492.

Clearance record

Decision date
Received
(33 days to decision)
Product code
ELM Denture, Plastic, Teeth
Regulation
21 CFR 872.3590
Device class
Class II
Review panel
Dental
Applicant
Oki Shiks USA , Ltd. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code ELM

Trailing 12 months

FDA records hold no clearances under product code ELM in the trailing twelve months.

FDA records show no clearances under product code ELM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ELM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260