Solea

Powered Laser Surgical Instrument

CONVERGENT DENTAL, INC

The following data is part of a premarket notification filed by Convergent Dental, Inc with the FDA for Solea.

Pre-market Notification Details

• Device ID: K151306
• 510k Number: K151306
• Device Name: Solea
• Classification: Powered Laser Surgical Instrument
• Applicant: CONVERGENT DENTAL, INC 2 VISION DR. Natick, MA 01760
• Contact: Mike Manor
• Correspondent: Carrie Hetrick; EMERGO GROUP 816 CONGRESS AVENUE, SUITE 1400 Austn, TX 78701
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-05-18
• Decision Date: 2015-09-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850634007018	K151306	000
00850634007001	K151306	000