← Back to catalogue

KOMET Dental Diamond Instruments

FDA UDI

Class I (US FDA UDI)

by Gebr. Brasseler GmbH & Co. KG

Identity

Trade Name
KOMET Dental Diamond Instruments FDA UDI
Generic Name
Diamond dental bur, single-use FDA UDI
Model / Reference
5858SU.314.014.GS FDA UDI

Identifiers

Catalog Number
5858SU.314.014 FDA UDI
Primary DI / UDI-DI
E226100022271 FDA UDI
FDA Product Code
DZP FDA UDI
GMDN Term
Diamond dental bur, single-use 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Diamond dental bur, single-use

KOMET Dental Diamond Instruments by Gebr. Brasseler GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diamond dental bur, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Gebr. Brasseler GmbH & Co. KG

Sources (1)

  • FDA UDI b931a659-5d09-45b2-8456-227bbde03911 33 fields · synced May 31, 2026