Cleared Traditional

K210011 - JS Dental Lab Mouth Guard (FDA 510(k) Clearance)

K210011 · Ampower Dental Laboratories, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
193d
Days
-
Risk

K210011 is an FDA 510(k) clearance for the JS Dental Lab Mouth Guard. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Ampower Dental Laboratories, LLC (Hayward, US). The FDA issued a Cleared decision on July 16, 2021 after a review of 193 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 Ampower Dental Laboratories, LLC devices

Submission Details

510(k) Number K210011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2021
Decision Date July 16, 2021
Days to Decision 193 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
66d slower than avg
Panel avg: 127d · This submission: 193d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Consultant

Elexes Medical Consulting, LLC
Parul Chansoria

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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