Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI
- Device Name
- Loosening with spray Recommended for the loosening of root canal posts, in combination with endodontic retreatment tips, and crowns. Apply the 5AE tip on the lingual or palatine surface and the buccal surface, before finishing with the occlusal surface. Use the flat extremity of the instrument held firmly against the tooth FDA UDI
- Model / Reference
- TIP 5AE FDA UDI
- Description
- Loosening with spray Recommended for the loosening of root canal posts, in combination with endodontic retreatment tips, and crowns. Apply the 5AE tip on the lingual or palatine surface and the buccal surface, before finishing with the occlusal surface. Use the flat extremity of the instrument held firmly against the tooth FDA UDI
Identifiers
- Catalog Number
- F00249 FDA UDI
- Primary DI / UDI-DI
- 03609820002491 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 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
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: Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Acteon by Satelec — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 6e9d550b-03a5-4a8b-abb2-c2b2786ed16d 35 fields · synced May 30, 2026