Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Dental ultrasonic surgical system FDA UDI
- Device Name
- Designed by SATELEC® , the IMPLANT CENTER 2 is a multifunction device intended for: • dental implantology, with its I-SURGE LED micromotor. • surgical procedures (osteotomy, osteoplasty, periodontal and implant surgery) with its PIEZOTOME LED handpiece. • mechanical ultrasonic treatment (prophylaxis, periodontics, endodontics) with its NEWTRON LED ultrasonic handpiece. FDA UDI
- Model / Reference
- IMPLANT CENTER 2 LED GP FDA UDI
- Description
- Designed by SATELEC® , the IMPLANT CENTER 2 is a multifunction device intended for: • dental implantology, with its I-SURGE LED micromotor. • surgical procedures (osteotomy, osteoplasty, periodontal and implant surgery) with its PIEZOTOME LED handpiece. • mechanical ultrasonic treatment (prophylaxis, periodontics, endodontics) with its NEWTRON LED ultrasonic handpiece. FDA UDI
Identifiers
- Catalog Number
- F27168 FDA UDI
- Primary DI / UDI-DI
- 03609820271682 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
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: 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
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 be6c725b-be49-491d-85a4-ca2d57e1b705 35 fields · synced Jun 8, 2026