Cleared Traditional

K143655 - SICAT OPTIMOTION

K143655 · Sicat GmbH & Co. KG · Dental device
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Oct 2015
Decision
283d
Days
-
Risk

K143655 is an FDA 510(k) clearance for the SICAT OPTIMOTION. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Sicat GmbH & Co. KG (Bonn, DE). The FDA issued a Cleared decision on October 2, 2015 after a review of 283 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 Sicat GmbH & Co. KG devices

FDA 510(k) Submission Details - K143655

510(k) Number K143655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2014
Decision Date October 02, 2015
Days to Decision 283 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 127d · This submission: 283d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

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