Cleared Traditional

K161884 - Ortho System

K161884 · 3Shape A/S · Dental device
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Apr 2017
Decision
282d
Days
-
Risk

K161884 is an FDA 510(k) clearance for the Ortho System. Classified as Mouthguard, Prescription (product code MQC).

Submitted by 3Shape A/S (Copenhagen, DK). The FDA issued a Cleared decision on April 19, 2017 after a review of 282 days - an extended review cycle.

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 3Shape A/S devices

Submission Details

510(k) Number K161884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2016
Decision Date April 19, 2017
Days to Decision 282 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 127d · This submission: 282d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 42
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