Tempsmart™ 009401

by Gc America Inc. 2 variants

Tempsmart™ 009401 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K141562 on 5 Sep 2014 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI D0470094011), active as of 22 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 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberD0470094011 UDI-DI	Date1 Aug 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK141562	Date5 Sep 2014Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K141562

Across registries

2 registries list this device

FDA 510(k) K141562 decided 5 Sep 2014 Active
FDA GUDID UDI-DI D0470094011 listed 1 Aug 2016 Listed

Timeline

2 dated events

5 Sep 2014 Cleared FDA 510(k) K141562
1 Aug 2016 Listed FDA GUDID D0470094011

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Tempsmart™
Generic name: Temporary dental crown/bridge resin
Model / Ref / Catalog: 009401

Primary DI / UDI-DI: D0470094011
510(k) Number: K141562
FDA product code: EBG
GMDN term: Temporary dental crown/bridge resin

Device class: Class II
Regulation number: 872.3770
GUDID distribution status: In Commercial Distribution

Size: Total Volume — 10 Milliliter

Similar devices in this category

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Other devices from Gc America Inc.

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Properties

Prescription use
Lot / batch number
Expiration date

Other properties (12, all answered No)