Brasseler USA

FDA UDI

Class I (US FDA UDI)

by Peter Brasseler Holdings, LLC

Identity

Trade Name: Brasseler USA FDA UDI
Generic Name: Dental abrasive point, reusable FDA UDI
Device Name: 0362C.21 PINK POINT RA 10P FDA UDI
Model / Reference: 5000810U0 FDA UDI
Description: 0362C.21 PINK POINT RA 10P FDA UDI

Identifiers

Primary DI / UDI-DI: 00887919402886 FDA UDI
FDA Product Code: EJQ FDA UDI
GMDN Term: Dental abrasive point, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6010 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

Moist Heat or Steam Sterilization FDA UDI

Category: Dental abrasive point, reusable

Brasseler USA by Peter Brasseler Holdings, LLC — 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: Peter Brasseler Holdings, LLC

Sources (1)

FDA UDI d48f9317-db15-49a4-b3cb-0d09885f1ef0 33 fields · synced May 31, 2026