Panels › General, Plastic Surgery › Product code NVK · Class 2
Laser, Dental, Soft Tissue
Regulation 878.4810
2510(k)s in 12 months (17 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in NVK
| Company | 510(k)s | Recalls |
|---|---|---|
| Shenzhen Soga Technology Co., Ltd. | 3 | 0 |
| Azena Medical, LLC | 2 | 0 |
| Convergent Dental, Inc. | 1 | 1 |
| El.En Electronic Engineering Spa | 2 | 0 |
| Biolase, Inc. | 1 | 0 |
| Dentlight, Inc. | 1 | 0 |
| Gigaalaser Company , Ltd. | 1 | 0 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | 1 | 0 |
| Kavo America | 1 | 0 |
| Matelaser, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2023 | Convergent Dental Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked Open, Classified |
NVK | K221761 |
| Jan 21, 2010 | Zap Lasers LLC SoftLase Pro Dental Lasers: Zap SoftLase, SoftLase Pro, OrthoLase, and HygieneLase models, Model numbers ZA-SLP, ZA-ORT, ZA-HYG, G22002SLP, ZA-SOFTLASE2WSII, ZA-SOFTLASER2W, Manufactured by Zap Laser Terminated |
NVK | None listed |
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