KOMET Dental Tungsten Carbide Burs

FDA UDI

Class I (US FDA UDI)

by Gebr. Brasseler GmbH & Co. KG

Identity

Trade Name: KOMET Dental Tungsten Carbide Burs FDA UDI
Generic Name: Carbide dental bur, reusable FDA UDI
Model / Reference: H47L.314.014.A2 FDA UDI

Identifiers

Catalog Number: H47L.314.014 FDA UDI
Primary DI / UDI-DI: E226000955A21 FDA UDI
FDA Product Code: EJL FDA UDI
GMDN Term: Carbide dental bur, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3240 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Carbide dental bur, reusable

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

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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 I	Pending data

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Manufacturer

Manufacturer: Gebr. Brasseler GmbH & Co. KG

Sources (1)

FDA UDI 684cba48-9d2d-4bd9-9769-881106a59d4e 33 fields · synced May 30, 2026