Brasseler USA

FDA UDI

Class I (US FDA UDI)

by Peter Brasseler Holdings, LLC

Identity

Trade Name: Brasseler USA FDA UDI
Generic Name: Diamond dental bur, single-use FDA UDI
Device Name: 6879K.31.016 (C) MOD RD SP 25P FDA UDI
Model / Reference: 012506SP FDA UDI
Description: 6879K.31.016 (C) MOD RD SP 25P FDA UDI

Identifiers

Primary DI / UDI-DI: 00887919827269 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Diamond dental bur, single-use

Brasseler USA by Peter Brasseler Holdings, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diamond dental bur, single-use.

PIRANHA DIAMOND — SS White Burs LLC · Class I
CleanCut™ Extended Use Diamond FG 801-021C| — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · Class I
Top Quality Manufacturing — TOP QUALITY MANUFACTURING, INC. · Class I
Top Quality Manufacturing — TOP QUALITY MANUFACTURING, INC. · Class I
OSUNG MND — Osung Mnd Co., Ltd. · Class I
REVELATION DIAMOND — SS White Burs LLC · Class I
OSUNG MND — Osung Mnd Co., Ltd. · Class I
Top Quality Manufacturing — TOP QUALITY MANUFACTURING, INC. · Class I

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

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

Manufacturer

Manufacturer: Peter Brasseler Holdings, LLC

Sources (1)

FDA UDI b623a031-ba7d-4220-832e-c74dbf05bfa0 33 fields · synced May 30, 2026