Cleared Traditional

CLAYTON INTRA-AURAL DEVICE (CID) (K091880) - FDA 510(k) Clearance

K091880 · Ascentia Health Incorporated · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
245d
Days
-
Risk

K091880 is an FDA 510(k) clearance for the CLAYTON INTRA-AURAL DEVICE (CID). Classified as Mouthguard, Prescription (product code MQC).

Submitted by Ascentia Health Incorporated (Springfield, US). The FDA issued a Cleared decision on February 24, 2010 after a review of 245 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 Ascentia Health Incorporated devices

Submission Details

510(k) Number K091880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2009
Decision Date February 24, 2010
Days to Decision 245 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 127d · This submission: 245d
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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