Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI
- Device Name
- Diamond-coated ball 107 μm Perform cuts on the incisal edge, by controlling the depth with the round tip radius. Then join the depth cuts to obtain an homothetic reduction of 1.5mm. Complete the vestibular reduction FDA UDI
- Model / Reference
- TIP PMV1 FDA UDI
- Description
- Diamond-coated ball 107 μm Perform cuts on the incisal edge, by controlling the depth with the round tip radius. Then join the depth cuts to obtain an homothetic reduction of 1.5mm. Complete the vestibular reduction FDA UDI
Identifiers
- Catalog Number
- F02021 FDA UDI
- Primary DI / UDI-DI
- 03609820020211 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Acteon by Satelec — 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
- Satelec
Sources (1)
- FDA UDI 84383433-058a-4830-80ee-ad253f6c39bb 35 fields · synced May 30, 2026