EdgePRO™
EdgePRO™ Protective Filter Eyewear EdgePRO™ Tinted Multi-Wavelength Protective Filter Eyewear
5manufacturers in China registered for this device type
25catalogue numbers in this listing
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 | US Endodontics, LLC, United States |
|---|---|
| FDA product code | NVK |
| Device type | Laser, Dental, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K213428 |
| Record published | 2023-06-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2201078 | In distribution | ||
| 7230008 | 30 | In distribution | |
| 6200194 | In distribution | ||
| 6200012 | In distribution | ||
| 6200209 | In distribution | ||
| 7240004 | In distribution | ||
| 6400463 | 2 | In distribution | |
| 7230012 | 30 | In distribution | |
| 7230015 | 30 | In distribution | |
| 2200199 | In distribution | ||
| 7220007 | In distribution | ||
| 6201812 | In distribution | ||
| 7240005 | In distribution | ||
| 7230009 | 30 | In distribution | |
| 6200111 | In distribution | ||
| 7210002 | In distribution | ||
| 7230011 | 30 | In distribution | |
| 6001029 | In distribution | ||
| 7230010 | 30 | In distribution | |
| 6200210 | 3 | In distribution | |
| 3200105 | In distribution | ||
| 2200696 | In distribution | ||
| 7210011 | In distribution | ||
| 4200218 | In distribution | ||
| Basket | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| DentaLaze Kit | Shofu Dental Corp. | 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.