Sofreliner Tough 23351

by Tokuyama Dental Corporation

Sofreliner Tough 23351 is a Class II device made by Tokuyama Dental Corporation, cleared under FDA 510(k) K030663 on 29 May 2003 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04548190233519), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04548190233519 UDI-DI	Date23 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK030663	Date29 May 2003Decided	StatusActive

Official records

AccessGUDID record UDI-DI 04548190233519
FDA 510(k) database 510(k) number K030663

Across registries

2 registries list this device

FDA 510(k) K030663 decided 29 May 2003 Active
FDA GUDID UDI-DI 04548190233519 listed 23 Sep 2016 Listed

Timeline

2 dated events

29 May 2003 Cleared FDA 510(k) K030663
23 Sep 2016 Listed FDA GUDID 04548190233519

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Sofreliner Tough
Generic name: Denture reliner, elastic, long-term
Model / reference: 23351

Primary DI / UDI-DI: 04548190233519
510(k) Number: K030663
FDA product code: EBI
GMDN term: Denture reliner, elastic, long-term

Device class: Class II
Regulation number: 872.3760
GUDID distribution status: In Commercial Distribution

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)