Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece FDA UDI
- Device Name
- Dental ultrasonic handpiece FDA UDI
- Model / Reference
- PAM LUMIERE A LEDS V3 SATELEC FDA UDI
- Description
- Dental ultrasonic handpiece FDA UDI
Identifiers
- Catalog Number
- F12609 FDA UDI
- Primary DI / UDI-DI
- 03609820126098 FDA UDI
- 510(k) Number
- K050895 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
No
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 system handpiece
Acteon by Satelec — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ultrasonic dental scaling/debridement system handpiece.
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- HuFriedyGroup — HU-FRIEDY MFG CO., LLC · Class II
- WOODPECKER, DTE — Guilin Woodpecker Medical Instrument Co., Ltd. · Class I
- VA-HP — NAKANISHI INC. · 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 b880e589-adca-4b43-9d4e-a7c40d8b53cb 36 fields · synced Jun 8, 2026