tempofit premium BL 04316

tempofit premium BL 04316 is a Class II device made by DETAX GmbH, listed in FDA GUDID since 25 Oct 2021 (UDI-DI EDET04316), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

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	NumberEDET04316 UDI-DI	Date25 Oct 2021Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: tempofit premium BL
Generic name: Temporary dental crown/bridge resin
Model / reference: 04316

Primary DI / UDI-DI: EDET04316
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

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Properties

Lot / batch number
Expiration date

Other properties (13, all answered No)