convergentdental.comSolea
Convergent Dental, Inc.
CONVERGENT DENTAL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010175098 | 3010175098 | CONVERGENT DENTAL | 1 | N | 2026-01-01 | 100 Fifth Avenue Suite 1010 Waltham MA US 02451 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850634007001 | Solea - The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy to ablate hard tissue or cut soft tissue in the oral cavity. The Solea system utilizes advanced CO2 laser technology with a wavelength of 9.3 µm to safely and effectively perform restorative and preventative dental procedures requiring ablation, incision, excision, vaporization, coagulation and hemostasis. | 1.800.880.8589 | info@convergentdental.com |
| 00850634007018 | Solea - The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy to ablate hard tissue or cut soft tissue in the oral cavity. The Solea system utilizes advanced CO2 laser technology with a wavelength of 9.3 µm to safely and effectively perform restorative and preventative dental procedures requiring ablation, incision, excision, vaporization, coagulation and hemostasis. | 1.800.880.8589 | info@convergentdental.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 154801 | 1162397513 | K221761 | Solea | NVK | 2022-09-14 |
| 154801 | 1113459785 | K151306 | Solea | GEX | 2015-09-23 |
| 154801 | 1810911178 | K130420 | SOLEA | GEX | 2013-07-12 |
| 154801 | 1355418129 | K123494 | SOLEA | GEX | 2013-02-11 |
Product Codes Associated With Registrations#
PMN#
GUDID#
Solea - The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy to ablate hard tissue or cut soft tissue in the oral cavity. The Solea system utilizes advanced CO2 laser technology with a wavelength of 9.3 µm to safely and effectively perform restorative and preventative dental procedures requiring ablation, incision, excision, vaporization, coagulation and hemostasis.
2018-06-11
Solea - The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy to ablate hard tissue or cut soft tissue in the oral cavity. The Solea system utilizes advanced CO2 laser technology with a wavelength of 9.3 µm to safely and effectively perform restorative and preventative dental procedures requiring ablation, incision, excision, vaporization, coagulation and hemostasis.
2016-09-16