Identity
- Trade Name
- Power Dental U.S.A., Inc. FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI
- Device Name
- CAVITRON ULTRA SONIC SCALER SPA 10/25K WITH SILICONE SLEEVES FDA UDI
- Model / Reference
- N7613 FDA UDI
- Description
- CAVITRON ULTRA SONIC SCALER SPA 10/25K WITH SILICONE SLEEVES FDA UDI
Identifiers
- Catalog Number
- N7613 FDA UDI
- Primary DI / UDI-DI
- D943N7613 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Power Dental U.S.A., Inc. by Power Dental USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Power Dental USA, Inc.
Sources (1)
- FDA UDI 78f8d033-766e-47a2-b75d-4c7f55871adc 36 fields · synced May 31, 2026