Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece FDA UDI
- Device Name
- Ultrawave, Ultradent’s new piezoelectric ultrasonic device, offers an intuitive design and ReflexTM technology that will give you and your patients a level of superior performance and gentle comfort other ultrasonic devices simply can’t. Scaling, endo, perio, and restorative procedures are now easier than ever, thanks to new advancements in piezoelectric technology. FDA UDI
- Model / Reference
- ULTRAWAVE XS LED HAND PIECE FDA UDI
- Description
- Ultrawave, Ultradent’s new piezoelectric ultrasonic device, offers an intuitive design and ReflexTM technology that will give you and your patients a level of superior performance and gentle comfort other ultrasonic devices simply can’t. Scaling, endo, perio, and restorative procedures are now easier than ever, thanks to new advancements in piezoelectric technology. FDA UDI
Identifiers
- Catalog Number
- F12617 FDA UDI
- Primary DI / UDI-DI
- 03609820126173 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system handpiece 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ultrasonic dental scaling/debridement systemUltrasonic dental scaling/debridement system handpiece
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 668cb602-0057-414d-95d4-166cae9160c7 35 fields · synced May 31, 2026