tempofit premium BL

FDA UDI

Class II (US FDA UDI)

by DETAX GmbH

Identity

Trade Name: tempofit premium BL FDA UDI
Generic Name: Temporary dental crown/bridge resin FDA UDI
Model / Reference: 04316 FDA UDI

Identifiers

Primary DI / UDI-DI: EDET04316 FDA UDI
FDA Product Code: EBG FDA UDI
GMDN Term: Temporary dental crown/bridge resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3770 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Temporary dental crown/bridge resin

tempofit premium BL by DETAX GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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PORTUX CAD/CAM Disc. 98.5X 25mm C2. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A · Class II
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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: DETAX GmbH

Sources (1)

FDA UDI 8d000fdd-847d-4f84-a0b4-b9b09f377d85 33 fields · synced Jun 1, 2026