SmartLite® Pro
SmartLite® Pro-Endo Resto Kit
7manufacturers in China registered for this device type
1catalogue number
7510(k) clearances naming this product code
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 LLC, United States |
|---|---|
| FDA product code | EBZ |
| Device type | Activator, Ultraviolet, For Polymerization |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6070 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2022-08-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Use product at room temperature.; Storage environment humidity up to 74 % RH; Storage environment temperature -5 to 35 °C; Special storage condition: Do not use after expiration date.; Special storage condition: Protect from moisture.; Special storage condition: Store at relative humidity range <75% (non-condensing) |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 644440 | Handpiece with cure tip, transillumination tip, batteries, charging base, accessories box, EndoActivator attachment with 25 small tips, 25 medium tips, 25 medium long tips, and 100 barrier sleeves | 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 |
|---|---|
| K041372 | 2004-06-24 |
| K031615 | 2003-07-21 |
| K951425 | 1995-05-05 |
| K882145 | 1988-09-06 |
| K832320 | 1983-08-31 |
| K801588 | 1980-09-16 |
| K770599 | 1977-04-05 |
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.