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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
Dental laboratory power tool system FDA UDI
Device Name
ENDOSYNC PLUS FDA UDI
Model / Reference
5027135RF FDA UDI
Description
ENDOSYNC PLUS FDA UDI

Identifiers

Primary DI / UDI-DI
00887919853848 FDA UDI
510(k) Number
K112665 FDA UDI
FDA Product Code
EKX FDA UDI
GMDN Term
Dental laboratory power tool system 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

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental laboratory power tool system

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

Similar devices

Also classified as Dental laboratory power tool system.

Cleared under the same submission

K112665 also covers:

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 cf706142-cf1e-414c-9378-a061889145b8 34 fields · synced May 30, 2026