Cleared Special

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

K232087 · Formlabs Ohio, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
218d
Days
-
Risk

K232087 is an FDA 510(k) clearance for the Dental LT Comfort Resin. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Formlabs Ohio, Inc. (Millbury, US). The FDA issued a Cleared decision on February 16, 2024 after a review of 218 days - an extended review cycle.

This device falls under the Dental FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Formlabs Ohio, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 127d · This submission: 218d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 40
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