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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K151306

Solea · Convergent Dental, Inc. · decided 2015-09-23 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
SoleaModel 2.0CONVERGENT DENTAL, INC.GEX00850634007001
SoleaModel 3.0CONVERGENT DENTAL, INC.GEX00850634007018