Cleared Traditional

Solea

K221761 · Convergent Dental, Inc. · Dental

Sep 2022

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K221761 is an FDA 510(k) clearance for the Solea, a Laser, Dental, Soft Tissue (Class II — Special Controls, product code NVK), submitted by Convergent Dental, Inc. (Needham, US). The FDA issued a Cleared decision on September 14, 2022, 89 days after receiving the submission on June 17, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K221761 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2022
Decision Date	September 14, 2022
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NVK — Laser, Dental, Soft Tissue
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	Intended For The Incision, Excision, Cutting, Ablation, And Vaporization Of Soft Tissue In Oral And Maxillofacial Surgery And Dentistry.