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Edenta

FDA UDI

Class I (US FDA UDI)

by Edenta Etablissement

Identity

Trade Name
EDENTA FDA UDI
Generic Name
Dental laboratory bur FDA UDI
Device Name
CeraTec - knife edge yellow FDA UDI
Model / Reference
960.240HP FDA UDI
Description
CeraTec - knife edge yellow FDA UDI

Identifiers

Primary DI / UDI-DI
E312960240HP1 FDA UDI
FDA Product Code
DZP FDA UDI
GMDN Term
Dental laboratory bur FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4535 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental laboratory bur

Edenta by Edenta Etablissement — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental laboratory bur.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edenta Etablissement

Sources (1)

  • FDA UDI d1162fd7-a386-424e-9d1d-ac55cdc11ce0 33 fields · synced May 31, 2026