Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Device Name
- The perfectly-controlled vibrations and high-quality tips bring to treatments more preservation, efficacy and comfort. Treatments guided in real time with B.LED technology which simultaneously reveals and remove dental plaque. The widest range of tips (80) for a great clinical expertise and versatility, supporting both practitioners and patients. FDA UDI
- Model / Reference
- NEWT P5 B LED USA KIT INTRO V4 FDA UDI
- Description
- The perfectly-controlled vibrations and high-quality tips bring to treatments more preservation, efficacy and comfort. Treatments guided in real time with B.LED technology which simultaneously reveals and remove dental plaque. The widest range of tips (80) for a great clinical expertise and versatility, supporting both practitioners and patients. FDA UDI
Identifiers
- Catalog Number
- F61117 FDA UDI
- Primary DI / UDI-DI
- 03609820611174 FDA UDI
- 510(k) Number
- K132267 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
No
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.
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- DTE — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- PIEZO Tip BE-2 — BONART CO., LTD. · Class II
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- Baolai — Nanning Baolai Medical Instrument Co., Ltd. · Class II
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 a75e3dce-9b70-4b50-a61b-ae74b3bee64e 36 fields · synced May 30, 2026