Identity
- Trade Name
- PROPHYflex 4 Wave FDA UDI
- Generic Name
- Dental abrasive air jet system handpiece FDA UDI
- Device Name
- Powder jet handpieces EUDAMEDThis is a medical device. FDA UDI
- Model / Reference
- 1.011.9403 EUDAMEDFDA UDI
- Description
- This is a medical device. FDA UDI
Identifiers
- Catalog Number
- 4 Perio Kit FDA UDI
- Primary DI / UDI-DI
- EKAV101194030 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EKAVG505ZB EUDAMED
- FDA Product Code
- EFB FDA UDI
- EMDN Code
- Z12119007 DENTAL PROPHYLAXIS EQUIPMENT EUDAMED
- GMDN Term
- Dental abrasive air jet system handpiece FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Germany 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
Yes
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 abrasive air jet system handpiece
PROPHYflex 4 Wave by KaVo Dental 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
- KaVo Dental GmbH
Sources (2)
- FDA UDI cf734c71-770f-4466-8b69-4d249835410f 36 fields · synced Jul 8, 2026
- EUDAMED ceb465af-fa2b-4934-9251-806833a3720b 61 fields · synced Jul 8, 2026