Identity
- Trade Name
- Velopex AquaCut Fluid Abrasion Unit FDA UDI
- Generic Name
- Dental abrasive air jet system FDA UDI
- Model / Reference
- MK5 FDA UDI
Identifiers
- Catalog Number
- I/MAC8502F /I/MAC8503F /I/MAC8508F FDA UDI
- Primary DI / UDI-DI
- 05060209580012 FDA UDI
- 510(k) Number
- K024105 FDA UDI
- FDA Product Code
- KOJ FDA UDI
- GMDN Term
- Dental abrasive air jet system 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
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
Velopex AquaCut Fluid Abrasion Unit by Medivance Instruments Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Medivance Instruments Limited
Sources (1)
- FDA UDI 6bd055c7-4244-42de-946e-40e0772122b0 34 fields · synced Jun 8, 2026