Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Dental ultrasonic surgical system handpiece tip FDA UDI
- Device Name
- The hydrodynamic sinus lift technique by the crestal approach. The diamond-coated tips, of increasing diameters (from 1.35mm to 2.80mm), are designed to drill and widen gradually the access canal to the Schneider membrane. The sterile spray cools down the tips to avoid any rise in temperature, which could lead to tissue damage. The membrane elevation is achieved using the TKW5 by means of microcavitation. FDA UDI
- Model / Reference
- SL INTRALIFT KIT FDA UDI
- Description
- The hydrodynamic sinus lift technique by the crestal approach. The diamond-coated tips, of increasing diameters (from 1.35mm to 2.80mm), are designed to drill and widen gradually the access canal to the Schneider membrane. The sterile spray cools down the tips to avoid any rise in temperature, which could lead to tissue damage. The membrane elevation is achieved using the TKW5 by means of microcavitation. FDA UDI
Identifiers
- Catalog Number
- F87336 FDA UDI
- Primary DI / UDI-DI
- 03609820873367 FDA UDI
- 510(k) Number
- K091252 FDA UDI
- FDA Product Code
- DZI FDA UDI
- GMDN Term
- Dental ultrasonic surgical system handpiece tip 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental ultrasonic surgical system handpiece tip
Acteon by Satelec — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental ultrasonic surgical system handpiece tip.
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- 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 add10d56-936c-4f62-931a-4084cfaa466f 36 fields · synced May 30, 2026