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Clinician's Choice® G5 Sample Pack

FDA UDI

Class II (US FDA UDI)

by Den-Mat Holdings, LLC

Identity

Trade Name
Clinician's Choice® G5 Sample Pack FDA UDI
Generic Name
Dental coating, tooth-desensitizing, professional FDA UDI
Device Name
Dental coating, tooth-desensitizing, professional FDA UDI
Model / Reference
972605 FDA UDI
Description
Dental coating, tooth-desensitizing, professional FDA UDI

Identifiers

Catalog Number
972605 FDA UDI
Primary DI / UDI-DI
00359883006501 FDA UDI
510(k) Number
K953504 FDA UDI
FDA Product Code
KLE FDA UDI
GMDN Term
Dental coating, tooth-desensitizing, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3200 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

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 5 Milliliter FDA UDI

Category: Dental coating, tooth-desensitizing, professional

Clinician's Choice® G5 Sample Pack by Den-Mat Holdings, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental coating, tooth-desensitizing, professional.

Cleared under the same submission

K953504 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Den-Mat Holdings, LLC

Sources (1)

  • FDA UDI 0a6d2a4f-b470-4358-b7d6-ad715b84090d 38 fields · synced Jun 9, 2026