Cleared Traditional

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

K222061 · Formlabs Ohio, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2022
Decision
120d
Days
-
Risk

K222061 is an FDA 510(k) clearance for the Dental LT Clear V2 Resin. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Formlabs Ohio, Inc. (Millbury, US). The FDA issued a Cleared decision on November 10, 2022 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Formlabs Ohio, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 127d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 40
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K222061.
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