DentaLaze Kit
DentaLaze Diode Laser Kit with the following content: Laser Handpiece (Main Control & Battery), 2 goggles, 1 laser shield, 5 fiber tips, 50 laser sheaths, 1 charging stand, 1 power adapter,…
DentaLaze Diode Laser Kit with the following content: Laser Handpiece (Main Control & Battery), 2 goggles, 1 laser shield, 5 fiber tips, 50 laser sheaths, 1 charging stand, 1 power adapter, IFU, Box Oversleeve, Labels: box, fiber tips, charging stand, Danger sign
Who Else Makes It
Concentrated in Guangxi (1), Guangdong (1), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Shenzhen Soga Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| CAO (China) Medical Equipment Company, Limited | Langfang | Hebei | Contract manufacturer | 6 |
| Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. | Shanghai | Shanghai | Manufacturer | 5 |
| Gigaalaser Company Ltd. | Wuhan | Hubei | Contract manufacturer | 5 |
Record
| Listed by | Shofu Dental Corp., United States |
|---|---|
| FDA product code | NVK |
| Device type | Laser, Dental, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Repacker / relabeller |
| 510(k) | K201387 |
| Record published | 2023-06-06 |
| Record revised | 2025-05-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DL001 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EdgePRO™ | US Endodontics, LLC | 25 |
| Gemini EVO | Azena Medical | 6 |
| Gigaa | Gigaalaser Company Ltd. | 4 |
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 2 |
| DTE | Guilin Woodpecker Medical Instrument Co., Ltd. | 2 |
| Gemini Nova Laser Kit – Demo | Azena Medical | 1 |
| Picasso Pro Disposable Therapy Tip, Curved | CAO Group, Inc. | 1 |
| Gemini Nova Wand Battery 1pk | Azena Medical | 1 |
| Gemini Nova Laser Kit – US | Azena Medical | 1 |
| Ultrafast Diode Laser | Dentlight Inc. | 1 |
| Gemini Nova Extraoral PBM Adapter kit 25mm | Azena Medical | 1 |
| Picasso Pro Disposable Therapy Tip, Straight | CAO Group, Inc. | 1 |
Showing 12 of 17. All products under Laser, Dental, Soft Tissue
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.