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Visalys Temp

FDA UDI

Class II (US FDA UDI)

by Kettenbach GmbH & Co. KG

Identity

Trade Name
Visalys Temp FDA UDI
Generic Name
Temporary dental crown/bridge FDA UDI
Device Name
Visalys Temp A2 USA Normal pack FDA UDI
Model / Reference
13781US FDA UDI
Description
Visalys Temp A2 USA Normal pack FDA UDI

Identifiers

Catalog Number
13781US FDA UDI
Primary DI / UDI-DI
E21713781US1 FDA UDI
510(k) Number
K122039 FDA UDI
FDA Product Code
EBG FDA UDI
GMDN Term
Temporary dental crown/bridge FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3770 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Visalys Temp by Kettenbach GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K122039 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kettenbach GmbH & Co. KG

Sources (1)

  • FDA UDI 14ebc595-9af9-4e89-bacb-bdfd375f6b26 36 fields · synced Jun 1, 2026