Cleared Traditional

K091880 - CLAYTON INTRA-AURAL DEVICE (CID)

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

FDA 510(k) Submission Details - K091880

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 128d · This submission: 245d
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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