Identity
- Trade Name
- RONDOflex powder 27m (75g) FDA UDI
- Generic Name
- Professional dental abrasive material FDA UDI
- Device Name
- This is a medical device.This is a medical device. FDA UDI
- Model / Reference
- 1.000.5955 FDA UDI
- Description
- This is a medical device.This is a medical device. FDA UDI
Identifiers
- Catalog Number
- NA FDA UDI
- Primary DI / UDI-DI
- EKAV100059550 FDA UDI
- 510(k) Number
- K042872 FDA UDI
- FDA Product Code
- KOJ FDA UDI
- GMDN Term
- Professional dental abrasive material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6080 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
Yes
FDA UDI
Category: Professional dental abrasive material
RONDOflex powder 27m (75g) by KaVo Dental GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- KaVo Dental GmbH
Sources (1)
- FDA UDI 14ebc469-13f0-4d77-b52b-e9a8d1f2ce4d 37 fields · synced May 30, 2026