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Brasseler USA

FDA UDI

Class II (US FDA UDI)

by Peter Brasseler Holdings, LLC

Identity

Trade Name
Brasseler USA FDA UDI
Generic Name
Dental reinforcing fibre FDA UDI
Device Name
SEQ101 WHT CARTRIDGE KIT 1P 25ML SEQ CORE MATERIAL FDA UDI
Model / Reference
5013880U0 FDA UDI
Description
SEQ101 WHT CARTRIDGE KIT 1P 25ML SEQ CORE MATERIAL FDA UDI

Identifiers

Primary DI / UDI-DI
00887919581345 FDA UDI
FDA Product Code
EBF FDA UDI
GMDN Term
Dental reinforcing fibre FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3690 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental reinforcing fibre

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

Similar devices

Also classified as Dental reinforcing fibre.

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 1badde02-d184-4301-b570-bc3aa869f0a0 33 fields · synced Jun 1, 2026