Brasseler USA

FDA UDI

Class I (US FDA UDI)

by Peter Brasseler Holdings, LLC

Identity

Trade Name: Brasseler USA FDA UDI
Generic Name: Pneumatic dental handpiece coupler FDA UDI
Device Name: NL11TI COUPLER 1P FDA UDI
Model / Reference: 5021282U0 FDA UDI
Description: NL11TI COUPLER 1P FDA UDI

Identifiers

Primary DI / UDI-DI: 00887919659945 FDA UDI
FDA Product Code: EFB FDA UDI
GMDN Term: Pneumatic dental handpiece coupler FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Pneumatic dental handpiece coupler

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

Similar devices

Also classified as Pneumatic dental handpiece coupler.

Airlight — Beyes Dental Canada Inc · Class I
SABLE Quick Connect — Sable Industries Inc · Class I
MK-dent — MK-Dent GmbH · Class I
RA-24 Roto Quick 6-Hole — W & H Dentalwerk Bürmoos GmbH · Class I
Airlight — Beyes Dental Canada Inc · Class I
MK-dent Germany® — MK-Dent GmbH · Class I
Airlight — Beyes Dental Canada Inc · Class I
DENTALAIRE — Beyes Dental Canada 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 f9f4a806-6241-4b08-b8ac-76f79f6bb0d9 33 fields · synced May 30, 2026