Cleared Special

K232087 - Dental LT Comfort Resin (FDA 510(k) Clearance)

K232087 · Formlabs Ohio, Inc. · Dental device

Feb 2024

Decision

218d

Days

Risk

K232087 is an FDA 510(k) clearance for the Dental LT Comfort Resin. This device is classified as a Mouthguard, Prescription.

Submitted by Formlabs Ohio, Inc. (Millbury, US). The FDA issued a Cleared decision on February 16, 2024, 218 days after receiving the submission on July 13, 2023.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number	K232087 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 13, 2023
Decision Date	February 16, 2024
Days to Decision	218 days
Submission Type	Special
Review Panel	Dental (DE)
Summary	Summary PDF