Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Dental ultrasonic surgical system handpiece tip FDA UDI
- Device Name
- Crest splitting: easy and controlled technique A thin crest is no more a barrier to place implants. The CS tips can smoothly enlarge the crest, one by one, avoiding the risks of bone breaking. This technique is faster and less exhausting for both practitioners and patients than the use of manual materials. Moreover the recommended irrigation flow and the hemostatic effect of the ultrasonics reduce bleeding. These conditions optimize the visibility of the surgical field. FDA UDI
- Model / Reference
- KIT CREST SPLITTING PZTII LED FDA UDI
- Description
- Crest splitting: easy and controlled technique A thin crest is no more a barrier to place implants. The CS tips can smoothly enlarge the crest, one by one, avoiding the risks of bone breaking. This technique is faster and less exhausting for both practitioners and patients than the use of manual materials. Moreover the recommended irrigation flow and the hemostatic effect of the ultrasonics reduce bleeding. These conditions optimize the visibility of the surgical field. FDA UDI
Identifiers
- Catalog Number
- F87567 FDA UDI
- Primary DI / UDI-DI
- 03609820875675 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 262fae9a-3c4e-4727-af4b-6157948b4d28 36 fields · synced May 30, 2026