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

FDA 510(k) Submission Details - K182820

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.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

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