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Solea

by Convergent Dental, Inc. 4 variants

510(k) K221761

Solea is a medical device (FDA Class II; FDA product code NVK, Laser, Dental, Soft Tissue) made by Convergent Dental, Inc., cleared under FDA 510(k) K221761 on 14 Sep 2022, active as of 11 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK221761 Date14 Sep 2022ClearedStatusActive

Official records

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0324-2024 FDA Class II initiated 1 Sep 2023

    It has been found that potential unintended laser activation can occur without foot pedal depression.

Timeline

2 dated events

  1. Cleared FDA 510(k) K221761
  2. Recall initiated FDA recalls Z-0324-2024

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
NVK
Device class
Class II
Regulation
21 CFR Part 878.4810
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code NVK (Laser, Dental, Soft Tissue).

Other devices from Convergent Dental

  • Solea Model 3.0

    Class II

  • Solea Model 2.0

    Class II

  • Solea

    Class II

  • Solea

    Class II

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