Identity
- Trade Name
- AM-20 RM EUDAMEDAM-20 RM Air Motor FDA UDI
- Generic Name
- Dental surgical power tool motor, pneumatic FDA UDI
- Device Name
- Air Motors R&P/Prophy&Paro EUDAMEDMicro Air Motor FDA UDI
- Model / Reference
- 30106000 EUDAMEDFDA UDI
- Description
- Micro Air Motor FDA UDI
Identifiers
- Primary DI / UDI-DI
- +J021301060001 EUDAMEDJ021301060001 FDA UDI
- Basic UDI-DI
- ++J021RP0004QE EUDAMED
- Direct Marketing DI
- +J021301060000 EUDAMED
- FDA Product Code
- EFB FDA UDI
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Dental surgical power tool motor, pneumatic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Moist Heat or Steam Sterilization FDA UDI
Category: Dental surgical power tool motor, pneumatic
AM-20 RM Air Motor by W & H Dentalwerk Bürmoos GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- W & H Dentalwerk Bürmoos GmbH
Sources (2)
- FDA UDI b9a5ebd9-e574-485b-ab6b-a58b716a0b55 33 fields · synced Sep 17, 2026
- EUDAMED 91ece14e-145d-4874-8058-b60f05526da2 61 fields · synced Sep 17, 2026