Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI
- Device Name
- Preparation, shoulder shape, diamond-coated tip 76 μm First instrument of the ultrasonic sequence, after the rotary phase. Penetration of the sulcus to continue preparation the dentine, in order to correct the "lip" of the preparation and obtain a shoulder-shape finishing line. FDA UDI
- Model / Reference
- TIP PMS1 FDA UDI
- Description
- Preparation, shoulder shape, diamond-coated tip 76 μm First instrument of the ultrasonic sequence, after the rotary phase. Penetration of the sulcus to continue preparation the dentine, in order to correct the "lip" of the preparation and obtain a shoulder-shape finishing line. FDA UDI
Identifiers
- Catalog Number
- F02254 FDA UDI
- Primary DI / UDI-DI
- 03609820022543 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 5c246f0f-009a-40cf-aa5c-847ea3434a1e 35 fields · synced May 30, 2026