Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Dental ultrasonic surgical system handpiece tip FDA UDI
- Device Name
- SINUS LIFT KIT Visibility and security for lateral sinus lift. The Sinus Lift Kit offers the practitioner a straightforward and safe answer for performing sinus elevation. The diamond-coated Sinus Lift tips for window cutting and the three spatula tips for membrane detachment are cooled by the sterile spray (thus avoiding tissue damage from exposure to high temperatures). FDA UDI
- Model / Reference
- KIT SINUS LIFT PZT 2 FDA UDI
- Description
- SINUS LIFT KIT Visibility and security for lateral sinus lift. The Sinus Lift Kit offers the practitioner a straightforward and safe answer for performing sinus elevation. The diamond-coated Sinus Lift tips for window cutting and the three spatula tips for membrane detachment are cooled by the sterile spray (thus avoiding tissue damage from exposure to high temperatures). FDA UDI
Identifiers
- Catalog Number
- F87519 FDA UDI
- Primary DI / UDI-DI
- 03609820875194 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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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 c8336af9-18da-4eb9-bec4-84767800ba76 36 fields · synced May 30, 2026