Affinity™ Multi-Prep® Wash Material 2-Pack Kit

FDA UDI

Class I (US FDA UDI)

by Den-Mat Holdings, LLC

Identity

Trade Name: Affinity™ Multi-Prep® Wash Material 2-Pack Kit FDA UDI
Generic Name: Silicone dental impression material FDA UDI
Device Name: Extended Working Time VPS Impression Material FDA UDI
Model / Reference: 632200 FDA UDI
Description: Extended Working Time VPS Impression Material FDA UDI

Identifiers

Catalog Number: 632200 FDA UDI
Primary DI / UDI-DI: 00359883005573 FDA UDI
FDA Product Code: EID FDA UDI
ELW FDA UDI
GMDN Term: Silicone dental impression material FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
872.3660 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

Yes

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

Dimensions & Sizes

Size: Total Volume — 50 Milliliter FDA UDI

Category: Silicone dental impression material

Affinity™ Multi-Prep® Wash Material 2-Pack Kit by Den-Mat Holdings, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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BISSNEHMEWACHS GELB (weich) — Gebdi Dental-Products GmbH · Class I
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Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Den-Mat Holdings, LLC

Sources (1)

FDA UDI 0a51dd3a-63c6-4b95-bd26-eed853088db5 37 fields · synced Jun 9, 2026