Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI
- Device Name
- Condensation, Piezocem Condensation tip for inlays or onlays on posterior teeth. The application is performed by sequences of ten seconds each time, until the prosthesis is perfectly integrated into the cavity. In general two to three sequences are sufficient; after each sequence the excess cement is removed from the margin edges FDA UDI
- Model / Reference
- TIP C20 FDA UDI
- Description
- Condensation, Piezocem Condensation tip for inlays or onlays on posterior teeth. The application is performed by sequences of ten seconds each time, until the prosthesis is perfectly integrated into the cavity. In general two to three sequences are sufficient; after each sequence the excess cement is removed from the margin edges FDA UDI
Identifiers
- Catalog Number
- F00113 FDA UDI
- Primary DI / UDI-DI
- 03609820001135 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 0f281790-63b5-4ce5-88f5-d3b29f925ba0 35 fields · synced Jun 8, 2026