Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Dental ultrasonic surgical system handpiece tip FDA UDI
- Device Name
- For delicate extractions with less post-operative trauma. This kit of instruments, adapted to the anatomical context, is intended for clinical acts such as extraction of wisdom teeth, fractured roots, impacted teeth and root section. The tip gently slips between the root and "gently". Micro-ultrasonic oscillations cause detachment of the ligament without damaging the surrounding soft tissue. FDA UDI
- Model / Reference
- KIT LC EXTRACTION FDA UDI
- Description
- For delicate extractions with less post-operative trauma. This kit of instruments, adapted to the anatomical context, is intended for clinical acts such as extraction of wisdom teeth, fractured roots, impacted teeth and root section. The tip gently slips between the root and "gently". Micro-ultrasonic oscillations cause detachment of the ligament without damaging the surrounding soft tissue. FDA UDI
Identifiers
- Catalog Number
- F87346 FDA UDI
- Primary DI / UDI-DI
- 03609820873466 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
Similar devices
Also classified as Dental ultrasonic surgical system handpiece tip.
- MECTRON — MECTRON SPA · Class II
- CI Tip — B&L Biotech Co., Ltd. · Class I
- MECTRON — MECTRON SPA · Class II
- Vista CT4 (Thin Condensation) Apical Surgery P5 Tip — Vista Dental · Class I
- PIEZON MASTER SURGERY — E.M.S. Electro Medical Systems S.A. · Class II
- PIEZON MASTER SURGERY — E.M.S. Electro Medical Systems S.A. · Class II
- MECTRON — MECTRON SPA · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Satelec
Sources (1)
- FDA UDI b5e4fc8f-c63b-4c22-a6e5-209d29aaa7c1 36 fields · synced May 30, 2026