Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- The AutoFocus by Acteon The power density (number of photons) of a lamp decreases significantly the farther away it is from the composite. To ensure effective polymerization, the exposure time would need to be calculated for each clinical procedure, according the position of the tooth, and even the shape of the composite. The AutoFocus function is an “active” system which enables automatic calculation of the time, and therefore of the ideal power density, required for deep polymerization of composites, whatever menu is selected. This will avoid under or overexposure of time and stop any inflammation.. FDA UDI
- Model / Reference
- HANDPIECE MINILED AF2 OEM FDA UDI
- Description
- The AutoFocus by Acteon The power density (number of photons) of a lamp decreases significantly the farther away it is from the composite. To ensure effective polymerization, the exposure time would need to be calculated for each clinical procedure, according the position of the tooth, and even the shape of the composite. The AutoFocus function is an “active” system which enables automatic calculation of the time, and therefore of the ideal power density, required for deep polymerization of composites, whatever menu is selected. This will avoid under or overexposure of time and stop any inflammation.. FDA UDI
Identifiers
- Catalog Number
- F05302 FDA UDI
- Primary DI / UDI-DI
- 03609820053028 FDA UDI
- 510(k) Number
- K072181 FDA UDI
- FDA Product Code
- EBZ FDA UDI
- GMDN Term
- Dental/surgical polymerization lamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6070 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental/surgical polymerization lamp
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 801b7b5b-1005-4cde-acf8-0bbec7d486e7 36 fields · synced May 31, 2026