BracePaste MTP Light Cure Primer
K-Number: K181910 · 2018-10-15
ApplicantAmerican Orthodontics
Decision Date2018-10-15
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BracePaste MTP Light Cure Primer is a medical device manufactured by American Orthodontics. It received FDA 510(k) clearance on 2018-10-15 under approval number K181910. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BracePaste MTP Light Cure Primer?
BracePaste MTP Light Cure Primer is a medical device that received FDA 510(k) clearance on 2018-10-15. It is manufactured by American Orthodontics. The 510(k) number is K181910.
When was BracePaste MTP Light Cure Primer approved by the FDA?
BracePaste MTP Light Cure Primer received FDA 510(k) clearance on 2018-10-15, under approval number K181910.
What company makes BracePaste MTP Light Cure Primer?
BracePaste MTP Light Cure Primer is manufactured by American Orthodontics.
What is the FDA product code for BracePaste MTP Light Cure Primer?
The FDA product code for BracePaste MTP Light Cure Primer is KLE.
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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.