Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Dental ultrasonic surgical system FDA UDI
- Device Name
- With Piezotome® CUBE bone surgery can be performed much faster with maximum power output and patient safety. The CUBE is especially effective with atraumatic extractions. Socket preservation, decreased patient pain and post operative swelling are enhanced with CUBE facilitating immediate implant placement. FDA UDI
- Model / Reference
- PIEZOTOME CUBE EMB USA FDA UDI
- Description
- With Piezotome® CUBE bone surgery can be performed much faster with maximum power output and patient safety. The CUBE is especially effective with atraumatic extractions. Socket preservation, decreased patient pain and post operative swelling are enhanced with CUBE facilitating immediate implant placement. FDA UDI
Identifiers
- Catalog Number
- F50108 FDA UDI
- Primary DI / UDI-DI
- 03609820501086 FDA UDI
- 510(k) Number
- K172137 FDA UDI
- FDA Product Code
- DZI FDA UDI
- GMDN Term
- Dental ultrasonic surgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4120 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: Dental ultrasonic surgical system
Acteon by Satelec — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental ultrasonic surgical system.
- DS Tip — B&L Biotech Co., Ltd. · Class I
- PIEZON MASTER SURGERY — E.M.S. Electro Medical Systems S.A. · Class II
- DTE, WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- TS Tip — B&L Biotech Co., Ltd. · Class I
- JETIP Bendable Jig — B&L Biotech Co., Ltd. · Class I
- TS Tip — B&L Biotech Co., Ltd. · Class I
- BONE TIP HOLDER SET (8 TIPS) — BONART CO., LTD. · Class II
- WOODPECKER — Guilin Woodpecker 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 41a13b7f-faee-41b5-86ee-fca6a6f3811a 36 fields · synced May 31, 2026