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: K123494
• 510k Number: K123494
• Device Name: SOLEA
• Classification: Powered Laser Surgical Instrument
• Applicant: CONVERGENT DENTAL, INC 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701
• Contact: Carrie Hetrick
• Correspondent: Carrie Hetrick; CONVERGENT DENTAL, INC 611 WEST 5TH STREET THIRD FLOOR Austin, 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: 2012-11-13
• Decision Date: 2013-02-11
• Summary: summary