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ZA-55 Scaler B.F. A-dec

FDA UDI

Class II (US FDA UDI)

by W & H Dentalwerk Bürmoos GmbH

Identity

Trade Name
ZA-55 Scaler B.F. A-dec FDA UDI
Generic Name
Pneumatic dental scaling/debridement system FDA UDI
Device Name
Air Scaler FDA UDI
Model / Reference
10035532 FDA UDI
Description
Air Scaler FDA UDI

Identifiers

Primary DI / UDI-DI
J021100355321 FDA UDI
FDA Product Code
ELC FDA UDI
GMDN Term
Pneumatic dental scaling/debridement system 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Pneumatic dental scaling/debridement system

ZA-55 Scaler B.F. A-dec by W & H Dentalwerk Bürmoos GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pneumatic dental scaling/debridement system.

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 4dcbcde3-b69c-4cf1-87b1-105ed7aefc84 33 fields · synced May 30, 2026