Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI
- Device Name
- IrrisafeTM files are used for irrigation once the root canal has been prepared. • 20ml of irrigant (NaOCl) are injected into the canal. • IrrisafeTM is inserted 2mm short of the working length and activated by performing withdrawal movements to flush the debris and the smear layer upwards. • Repeated 3x 1 minute in each canal. FDA UDI
- Model / Reference
- BOX 4 FILES IRR K25 LG 25 FDA UDI
- Description
- IrrisafeTM files are used for irrigation once the root canal has been prepared. • 20ml of irrigant (NaOCl) are injected into the canal. • IrrisafeTM is inserted 2mm short of the working length and activated by performing withdrawal movements to flush the debris and the smear layer upwards. • Repeated 3x 1 minute in each canal. FDA UDI
Identifiers
- Catalog Number
- F43806 FDA UDI
- Primary DI / UDI-DI
- 03609820438061 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 48c96b36-21d5-45fd-b8f8-3670dcc4b53a 35 fields · synced Jun 6, 2026