Affinity™ Multi-Prep® Tray Material 2pk Kit

FDA UDI

Class I (US FDA UDI)

by Clinician's Choice Dental Products, Inc.

Identity

Trade Name: Affinity™ Multi-Prep® Tray Material 2pk Kit FDA UDI
Generic Name: Silicone dental impression material FDA UDI
Device Name: Extended Working Time VPS Impression Material FDA UDI
Model / Reference: 631200 FDA UDI
Description: Extended Working Time VPS Impression Material FDA UDI

Identifiers

Catalog Number: 631200 FDA UDI
Primary DI / UDI-DI: 07540172009768 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

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® Tray Material 2pk Kit by Clinician's Choice Dental Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Clinician's Choice Dental Products, Inc.

Sources (1)

FDA UDI f5c12f83-e00a-47ab-85b5-d582684e1e0c 37 fields · synced May 31, 2026