Skip to content

Tokuyama Shield Force Plus 15141

by Tokuyama Dental Corporation

Tokuyama Shield Force Plus 15141 is a Class II device made by Tokuyama Dental Corporation, cleared under FDA 510(k) K100172 on 21 Oct 2010 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04548190151417), 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) K100172

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 Number04548190151417 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100172 Date21 Oct 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100172 decided 21 Oct 2010 Active
  • FDA GUDID UDI-DI 04548190151417 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K100172
  2. Listed FDA GUDID 04548190151417

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tokuyama Shield Force Plus
Generic name
Dental cavity varnish
Model / reference
15141
Primary DI / UDI-DI
04548190151417
510(k) Number
FDA product code
LBH
GMDN term
Dental cavity varnish
Device class
Class II
Regulation number
872.3260
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code LBH (Varnish, Cavity).

Other devices from Tokuyama Dental Corporation

See all devices from Tokuyama Dental Corporation →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)