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510(k) Data Aggregation
K Number
K221761Device Name
Solea
Manufacturer
Convergent Dental, Inc.
Date Cleared
2022-09-14
(89 days)
Product Code
NVK, GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Convergent Dental, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Solea system is indicated for the following:
- Ablation of hard tissue for caries removal and cavity prevention
- Incision, excision, vaporization, coagulation and hemostasis of soft tissue in the oral cavity
- Cutting, shaving, contouring and resection of oral osseous tissue (both)
- Aiding in the reduction of mineral loss in dental enamel
Device Description
The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy for ablation of hard tissue for caries removal and cavity preparation; incision, excision, vaporization, coagulation, and hemostasis of soft tissue in the oral cavity; cutting, shaving, contouring and resection of oral osseous tissue (bone). The Solea system utilizes CO2 laser technology with a wavelength of 9.3 um.
The modification to the cleared Solea system is the introduction of the DR Handpiece which allows the system to deliver controlled sub-ablative energy necessary to heat the tooth surface mineral without ablation for the new treatment of aiding in the reduction of mineral loss in the tooth enamel.
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