Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI
- Device Name
- The AS9D tip is for complex cases and allows preparation of the root canal up to the coronal third. The diamond coating of the AS9D is only present on the extremity of the instrument not to over-prepare the canal. FDA UDI
- Model / Reference
- TIP AS9D FDA UDI
- Description
- The AS9D tip is for complex cases and allows preparation of the root canal up to the coronal third. The diamond coating of the AS9D is only present on the extremity of the instrument not to over-prepare the canal. FDA UDI
Identifiers
- Catalog Number
- F00067 FDA UDI
- Primary DI / UDI-DI
- 03609820000671 FDA UDI
- 510(k) Number
- K132322 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
No
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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Cleared under the same submission
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 de16651f-99cc-4ea1-864b-edb547b28973 36 fields · synced Jun 1, 2026