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Tokuyama Rebase 20663

by Tokuyama Dental Corporation

Tokuyama Rebase 20663 is a Class II device made by Tokuyama Dental Corporation, cleared under FDA 510(k) K190940 on 4 Oct 2019 and listed in FDA GUDID since 28 Oct 2019 (UDI-DI 04548190206636), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K190940

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04548190206636 UDI-DI Date28 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK190940 Date4 Oct 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190940 decided 4 Oct 2019 Active
  • FDA GUDID UDI-DI 04548190206636 listed 28 Oct 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K190940
  2. Listed FDA GUDID 04548190206636

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tokuyama Rebase
Generic name
Denture reliner, hard
Model / reference
20663
Primary DI / UDI-DI
04548190206636
510(k) Number
FDA product code
EBI
GMDN term
Denture reliner, hard
Device class
Class II
Regulation number
872.3760
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing).

Other devices from Tokuyama Dental Corporation

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Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)