Solea

GUDID 00850634007018

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.

CONVERGENT DENTAL, INC.

Dental carbon dioxide laser system

• Primary Device ID: 00850634007018
• NIH Device Record Key: 9029f7fc-c85d-4b59-84c4-0409194f4b07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solea
• Version Model Number: Model 3.0
• Company DUNS: 063042443
• Company Name: CONVERGENT DENTAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1.800.880.8589
• Email: info@convergentdental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850634007018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151306

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00850634007018]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-12
• Device Publish Date: 2018-06-11

On-Brand Devices [Solea]

• 00850634007018: The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy t
• 00850634007001: The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy t