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Temp Premium Flexible

FDA UDI

Class II (US FDA UDI)

by Zirkonzahn GmbH

Identity

Trade Name
Temp Premium Flexible FDA UDI
Generic Name
Dental bridge, polymer FDA UDI
Device Name
Temp Premium Flexible A2-B2 98H20 with step FDA UDI
Model / Reference
TMAE6220 FDA UDI
Description
Temp Premium Flexible A2-B2 98H20 with step FDA UDI

Identifiers

Primary DI / UDI-DI
D800TMAE6220 FDA UDI
FDA Product Code
POW FDA UDI
EBG FDA UDI
GMDN Term
Dental bridge, polymer 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental bridge, polymer

Temp Premium Flexible by Zirkonzahn GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental bridge, polymer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zirkonzahn GmbH

Sources (1)

  • FDA UDI 4fa51aa6-664a-4a99-b6c0-1807c7e52c0c 33 fields · synced Jun 6, 2026