CONVERGENT DENTAL, INC.

Address:140 Kendrick St Bldg C3,Needham,MA,02494,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Powered Laser Surgical Instrument (GEX) (2)

Premarket Exempt

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Solea - 00850634007001 Catalog Number :

Device Description : The Solea system is a mobile, cart-based dental treatment system that uses pulse 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.

Device Class : 2

Duns Number: 063042443

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Solea - 00850634007018 Catalog Number :