Cleared Traditional

NIGHTGUARD DIAGNOSTIC APPLIANCE (K955701) - FDA 510(k) Clearance

K955701 · Cycura Corp. · Dental device
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Mar 1996
Decision
84d
Days
-
Risk

K955701 is an FDA 510(k) clearance for the NIGHTGUARD DIAGNOSTIC APPLIANCE. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Cycura Corp. (Rocklin, US). The FDA issued a Cleared decision on March 8, 1996 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cycura Corp. devices

Submission Details

510(k) Number K955701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1995
Decision Date March 08, 1996
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 70
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