ParaCore

FDA UDI

Class II (US FDA UDI)

by Coltène/Whaledent AG

Identity

Trade Name: ParaCore FDA UDI
Generic Name: Dental veneer, professional FDA UDI
Model / Reference: 1503 FDA UDI

Identifiers

Catalog Number: 1503 FDA UDI
Primary DI / UDI-DI: J00615030 FDA UDI
510(k) Number: K052820 FDA UDI
FDA Product Code: EBF FDA UDI
GMDN Term: Dental veneer, professional FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3690 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: Dental veneer, professional

ParaCore by Coltène/Whaledent AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental veneer, professional.

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crea.lign incisal E1 — bredent GmbH & Co. KG · Class II
Ceramill — Vertex-Dental B.V. · Class I
Duo:PCH® — Den-Mat Holdings, LLC · Class II
crea.lign Opaker 1 — bredent GmbH & Co. KG · Class II
Restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
Duo:PCH® — Den-Mat Holdings, LLC · Class II
Vertex-Dental BV — Vertex-Dental B.V. · Class I

Cleared under the same submission

K052820 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: Coltène/Whaledent AG

Sources (1)

FDA UDI bd1e257c-825d-430a-b371-feda5ac91299 36 fields · synced May 31, 2026