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Brasseler USA

FDA UDI

Class I (US FDA UDI)

by Peter Brasseler Holdings, LLC

Identity

Trade Name
Brasseler USA FDA UDI
Generic Name
Endodontic broach, serrated, single-use FDA UDI
Device Name
9107.634.030 XXF YELLOW 12P FDA UDI
Model / Reference
5014467U0 FDA UDI
Description
9107.634.030 XXF YELLOW 12P FDA UDI

Identifiers

Primary DI / UDI-DI
00887919589082 FDA UDI
FDA Product Code
EKW FDA UDI
GMDN Term
Endodontic broach, serrated, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Endodontic broach, serrated, single-use

A comprehensive medical device directory listing for the Brasseler USA Endodontic broach, a hand-held, manual instrument used in dental procedures to shape and enlarge root canal tissue or extirpate pulp. This single-use device is sterilized using moist heat or steam.

Similar devices

Also classified as Endodontic broach, serrated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Peter Brasseler Holdings, LLC

Sources (1)

  • FDA UDI d5cef7a9-9b0f-4cbb-a02d-81ca4da9c4cb 33 fields · synced Jun 24, 2026