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PEEK BioSolution

FDA UDI

Class II (US FDA UDI)

by Merz Dental GmbH

Identity

Trade Name
PEEK BioSolution FDA UDI
Generic Name
Preformed dental crown, permanent FDA UDI
Device Name
PEEK BioSolution A2/B2 diameter 98,5mm, thickness 30mm FDA UDI
Model / Reference
PEEK BioSolution A2/B2 diameter 98,5mm, thickness 30mm FDA UDI
Description
PEEK BioSolution A2/B2 diameter 98,5mm, thickness 30mm FDA UDI

Identifiers

Catalog Number
1018991 FDA UDI
Primary DI / UDI-DI
D7091018991 FDA UDI
FDA Product Code
EBF FDA UDI
GMDN Term
Preformed dental crown, permanent 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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
Height — 30 Millimeter FDA UDI
Outer Diameter — 98.5 Millimeter FDA UDI

Category: Preformed dental crown, permanent

PEEK BioSolution by Merz Dental GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Preformed dental crown, permanent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merz Dental GmbH

Sources (1)

  • FDA UDI edc399a2-33cf-45e0-9d89-cd984de18a91 36 fields · synced May 30, 2026