Acteon
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…
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..
Who Else Makes It
Concentrated in Guangdong (3), Guangxi (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Premium Plus (Dongguan) Limited | Dongguan | Guangdong | Repacker / relabeller | 34 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Dentall, Inc. | District | Beijing | Contract manufacturer | 13 |
| Guilin Refine Medical Instrument Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 7 |
Record
| Listed by | Satelec, United States |
|---|---|
| FDA product code | EBZ |
| Device type | Activator, Ultraviolet, For Polymerization |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6070 |
| 510(k) | K131906 |
| Record published | 2016-09-24 |
| Record revised | 2022-04-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SCANWAVE OEM PEN GRAY3 | In distribution | |
| MINILED AOC BLUE RAY 3 | In distribution | |
| MINILED BLACK | In distribution | |
| HANDPIECE MINILED AF2 OEM | In distribution | |
| HANDPIECE MINILED AOC BLUE RAY 3 | In distribution | |
| HANDPIECE SCANWAVE OEM PEN | In distribution | |
| HANDPIECE MINILED AOC BLUERAY 3 BLACK | In distribution | |
| MINILED AOC BLUERAY 3 BLACK | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valo | Ultradent Products Inc. | 59 |
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 37 |
| Ledex | Dentmate Technology Co., Ltd. | 34 |
| Coltolux | Coltene/Whaledent Gmbh & Co. KG | 27 |
| Valo X | Ultradent Products Inc. | 22 |
| Spec 3 | Coltene/Whaledent Gmbh & Co. KG | 20 |
| Bluephase G4 | Ivoclar Vivadent Aktiengesellschaft | 20 |
| Aurora™ | Parkell, Inc. | 18 |
| DTE | Guilin Woodpecker Medical Instrument Co., Ltd. | 17 |
| D-LUX+ | Diadent Group Intl., Inc. | 16 |
| Apoza | Apoza Enterprise Co., Ltd. | 15 |
| Soleil | Benco Dental Supply Co. | 15 |
Showing 12 of 139. All products under Activator, Ultraviolet, For Polymerization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K072181 | 2007-09-19 |
| K040808 | 2004-04-28 |
| K032465 | 2003-10-21 |
| K961735 | 1996-07-31 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.