Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Device Name
- The SP Newtron module is a multi-clinic piezo-ultrasonic unit that drives four modes (Perio, Endo, Scaling and "Boost") FDA UDI
- Model / Reference
- MF KIT NEWTRON ADEC 81" MG V3 FDA UDI
- Description
- The SP Newtron module is a multi-clinic piezo-ultrasonic unit that drives four modes (Perio, Endo, Scaling and "Boost") FDA UDI
Identifiers
- Catalog Number
- F55449 FDA UDI
- Primary DI / UDI-DI
- 03609820554495 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 d57dea05-ce6c-4c9d-9858-efd8b8e5044b 35 fields · synced May 30, 2026