BISICO Provi Temp K A3.5 50ml

FDA UDI

Class II (US FDA UDI)

by bisico Bielefelder Dentalsilicone GmbH & Co. KG

Identity

Trade Name: BISICO Provi Temp K A3.5 50ml FDA UDI
Generic Name: Temporary dental crown/bridge resin FDA UDI
Device Name: Temporary attachment cement for temporary crowns and bridges. FDA UDI
Model / Reference: 73580 FDA UDI
Description: Temporary attachment cement for temporary crowns and bridges. FDA UDI

Identifiers

Catalog Number: 73580 FDA UDI
Primary DI / UDI-DI: EBIB735801 FDA UDI
510(k) Number: K010012 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

Yes

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

BISICO Provi Temp K A3.5 50ml by bisico Bielefelder Dentalsilicone GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Temporary dental crown/bridge resin.

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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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YAMAHACHI PMMA DISK — YAMAHACHI DENTAL MFG., CO. · Class II

Cleared under the same submission

K010012 also covers:

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: bisico Bielefelder Dentalsilicone GmbH & Co. KG

Sources (1)

FDA UDI 7dda1fd2-c9fb-40a7-9c40-97d38e9f1d22 37 fields · synced May 31, 2026