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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
Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusable FDA UDI
Model / Reference
SF849.000.009.A1 FDA UDI

Identifiers

Catalog Number
SF849.000.009 FDA UDI
Primary DI / UDI-DI
E226042449A11 FDA UDI
FDA Product Code
DZP FDA UDI
GMDN Term
Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusable 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

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusable

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 Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gebr. Brasseler GmbH & Co. KG

Sources (1)

  • FDA UDI 9211f103-56cf-4507-aa22-f0af3d145c71 33 fields · synced May 30, 2026