SmartLite Focus
SmartLite Focus Intro Package is a cordless pen-style, LED light polymerization device for use by trained dental professionals or dental laboratories. SmartLite Focus is received as a…
SmartLite Focus Intro Package is a cordless pen-style, LED light polymerization device for use by trained dental professionals or dental laboratories. SmartLite Focus is received as a handpiece together with a battery pack. With its supporting accessories (Charging Base, Shields, SmartLite Sleeves, Power Connector) it can be classified as convenience kit.
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 | Dentsply De Trey GmbH |
|---|---|
| FDA product code | EBZ |
| Device type | Activator, Ultraviolet, For Polymerization |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6070 |
| Premarket notification | Exempt |
| Record published | 2020-12-16 |
| Record revised | 2026-01-15 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 35 °C; Special storage condition: Keep dry |
| Sizes | Length 5.9 to 7.5 cm; outer diameter 2 to 6.5 cm |
| Distribution end date | 2021-10-19 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 64450021 | Length 5.9 cm | In distribution | |
| 64450070 | Outer Diameter 6.5 cm | In distribution | |
| 64450050 | Length 7.5 cm | In distribution | |
| 64450040 | Outer Diameter 2 cm | 5 | In distribution |
| 64450020 | In distribution | ||
| 64450060 | Withdrawn |
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
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.