JS Dental Lab Mouth Guard
K-Number: K210011 · 2021-07-16
ApplicantAmpower Dental Laboratories, LLC
Decision Date2021-07-16
Product CodeMQC
DecisionSubstantially Equivalent
Device Summary
JS Dental Lab Mouth Guard is a medical device manufactured by Ampower Dental Laboratories, LLC. It received FDA 510(k) clearance on 2021-07-16 under approval number K210011. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the JS Dental Lab Mouth Guard?
JS Dental Lab Mouth Guard is a medical device that received FDA 510(k) clearance on 2021-07-16. It is manufactured by Ampower Dental Laboratories, LLC. The 510(k) number is K210011.
When was JS Dental Lab Mouth Guard approved by the FDA?
JS Dental Lab Mouth Guard received FDA 510(k) clearance on 2021-07-16, under approval number K210011.
What company makes JS Dental Lab Mouth Guard?
JS Dental Lab Mouth Guard is manufactured by Ampower Dental Laboratories, LLC.
What is the FDA product code for JS Dental Lab Mouth Guard?
The FDA product code for JS Dental Lab Mouth Guard is MQC.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.