Cleared Traditional

K222061 - Dental LT Clear V2 Resin (FDA 510(k) Clearance)

K222061 · Formlabs Ohio, Inc. · Dental device

Nov 2022

Decision

120d

Days

Risk

K222061 is an FDA 510(k) clearance for the Dental LT Clear V2 Resin. This device is classified as a Mouthguard, Prescription.

Submitted by Formlabs Ohio, Inc. (Millbury, US). The FDA issued a Cleared decision on November 10, 2022, 120 days after receiving the submission on July 13, 2022.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number	K222061 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 13, 2022
Decision Date	November 10, 2022
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF