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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 obturation material distribution endpiece, reusable FDA UDI
Device Name
BC PASTE FILLER 25 25MM 4P FDA UDI
Model / Reference
5027825U0 FDA UDI
Description
BC PASTE FILLER 25 25MM 4P FDA UDI

Identifiers

Primary DI / UDI-DI
00887919866497 FDA UDI
FDA Product Code
EKS FDA UDI
GMDN Term
Endodontic obturation material distribution endpiece, reusable 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 obturation material distribution endpiece, reusable

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

Similar devices

Also classified as Endodontic obturation material distribution endpiece, reusable.

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 d78d344b-1a21-4d41-b1db-f8ac59b748b4 33 fields · synced Jun 6, 2026