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Duo:PCH®

FDA UDI

Class II (US FDA UDI)

by Den-Mat Holdings, LLC

Identity

Trade Name
Duo:PCH® FDA UDI
Generic Name
Dental veneer, professional FDA UDI
Device Name
DUO PCH CTRL XL 4pc #8&9 RFL FDA UDI
Model / Reference
032913040 FDA UDI
Description
DUO PCH CTRL XL 4pc #8&9 RFL FDA UDI

Identifiers

Catalog Number
032913040 FDA UDI
Primary DI / UDI-DI
D8130329130401 FDA UDI
510(k) Number
K895269 FDA UDI
FDA Product Code
ELL FDA UDI
GMDN Term
Dental veneer, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3920 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental veneer, professional

Duo:PCH® by Den-Mat Holdings, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental veneer, professional.

Cleared under the same submission

K895269 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 bdda0a1c-5857-4443-a225-e9176eb5ee5b 37 fields · synced Jun 9, 2026