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Reigning Denture

by Oki Shiks USA, Ltd. 2 variants

510(k) K821217

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK821217 Date7 Jun 1982ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EBI
FDA applicant
Oki Shiks USA , Ltd.
Device Class
Class II
Regulation
21 CFR Part 872.3760
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

REIGNING DENTURE is a resin-based denture device used for relining, repairing, and rebasing dental prostheses. It is classified under product code EBI and falls within the dental specialty as determined by the FDA review panel.

The device received traditional 510(k) clearance from the FDA on June 7, 1982, under submission K821217. It was determined to be substantially equivalent to a legally marketed predicate device. The manufacturer is Oki Shiks USA, Ltd., located in McHenry, Illinois.

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