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Tip 2AU

FDA UDI

Class II (US FDA UDI)

by W & H Dentalwerk Bürmoos GmbH

Identity

Trade Name
Tip 2AU FDA UDI
Generic Name
Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI
Model / Reference
07159800 FDA UDI

Identifiers

Primary DI / UDI-DI
J021071598001 FDA UDI
510(k) Number
K100647 FDA UDI
FDA Product Code
ELC FDA UDI
GMDN Term
Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4850 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: Ultrasonic dental scaling/debridement system handpiece tip, periodontal

Tip 2AU by W & H Dentalwerk Bürmoos GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasonic dental scaling/debridement system handpiece tip, periodontal.

Cleared under the same submission

K100647 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
W & H Dentalwerk Bürmoos GmbH

Sources (1)

  • FDA UDI c02ecc95-6447-4b02-a9a1-dbc9b1890a0d 33 fields · synced May 30, 2026