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Brasseler USA

FDA UDI

Class U (US FDA UDI)

by Peter Brasseler Holdings, LLC

Identity

Trade Name
Brasseler USA FDA UDI
Generic Name
Endodontic apex locator FDA UDI
Device Name
WIRELE-X TOUCH PROBE 2P FDA UDI
Model / Reference
5031043U0 FDA UDI
Description
WIRELE-X TOUCH PROBE 2P FDA UDI

Identifiers

Primary DI / UDI-DI
00887919972228 FDA UDI
510(k) Number
K121206 FDA UDI
FDA Product Code
LQY FDA UDI
GMDN Term
Endodontic apex locator FDA UDI

Classification

Device Class
U 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

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 apex locator

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

Similar devices

Also classified as Endodontic apex locator.

Cleared under the same submission

K121206 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 75c6f8a5-62f1-45cf-829c-b941fc860c94 34 fields · synced May 30, 2026