Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Device Name
- Ultrawave XS, Ultradent’s new LED 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. The Ultrawave Color-Coding System and wide variety of tips, also compatible with most tips on the market, makes instrument management simple and efficient. FDA UDI
- Model / Reference
- ULTRAWAVE XS LED FDA UDI
- Description
- Ultrawave XS, Ultradent’s new LED 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. The Ultrawave Color-Coding System and wide variety of tips, also compatible with most tips on the market, makes instrument management simple and efficient. FDA UDI
Identifiers
- Catalog Number
- F58100 FDA UDI
- Primary DI / UDI-DI
- 03609820581002 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system 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
Category: Ultrasonic dental scaling/debridement system
Acteon by Satelec — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasonic dental scaling/debridement system.
- Henry Schein — HENRY SCHEIN, INC. · Class II
- BioSonic — Coltene/Whaledent Inc. · Class II
- TurboSENSOR™ — PARKELL, INC. · Class II
- DTE, WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- PIEZO Tip BE-2 — BONART CO., LTD. · Class II
- SONICflex prep crown plain No. 98 — KaVo Dental GmbH · Class I
- Baolai — Nanning Baolai Medical Instrument Co., Ltd. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Satelec
Sources (1)
- FDA UDI d8bb67e3-6d9a-47b6-9c9a-10d09660adac 35 fields · synced May 30, 2026