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Reigning Crown-Bridge/Polycarb. Resin

by Oki Shiks USA, Ltd.

510(k) K801237

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 NumberK801237 Date9 Jun 1980ClearedStatusActive

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  • Withdrawn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
EBF
FDA applicant
Oki Shiks USA , Ltd.
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

This device is a dental material used for crown and bridge applications, specifically a polycarbonate resin. It is classified under product code EBF and falls within the dental specialty as determined by the FDA review process.

The device received traditional 510(k) clearance (K801237) from the FDA on June 9, 1980, following a determination of substantial equivalence. It is manufactured by Oki Shiks USA, Ltd., and is intended for use in dental restorative procedures as a resin-based material for crowns and bridges.

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Questions

AI-generated answers, 26 Sep 2026

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

  • What is the REIGNING CROWN-BRIDGE/POLYCARB. RESIN used for?

    This device is a dental material used for crown and bridge applications, specifically a polycarbonate resin intended for use in dental restorative procedures as a resin-based material for crowns and bridges.

  • How was the REIGNING CROWN-BRIDGE/POLYCARB. RESIN cleared for market?

    The device received traditional 510(k) clearance (K801237) from the FDA on June 9, 1980, following a determination of substantial equivalence to a legally marketed predicate device.

  • Who manufactures the REIGNING CROWN-BRIDGE/POLYCARB. RESIN and where is it located?

    The device is manufactured by Oki Shiks USA, Ltd., located at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States.