Cleared Traditional

K182820 - The POD

K182820 · Advanced Facialdontics, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
286d
Days
-
Risk

K182820 is an FDA 510(k) clearance for the The POD. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Advanced Facialdontics, LLC (St James, US). The FDA issued a Cleared decision on July 17, 2019 after a review of 286 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 Advanced Facialdontics, LLC devices

Submission Details

510(k) Number K182820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2018
Decision Date July 17, 2019
Days to Decision 286 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
159d slower than avg
Panel avg: 127d · This submission: 286d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

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