Premium Teeth Resin
K-Number: K240538 · 2024-07-19
ApplicantFormlabs Ohio, Inc.
Decision Date2024-07-19
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Premium Teeth Resin is a medical device manufactured by Formlabs Ohio, Inc.. It received FDA 510(k) clearance on 2024-07-19 under approval number K240538. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Premium Teeth Resin?
Premium Teeth Resin is a medical device that received FDA 510(k) clearance on 2024-07-19. It is manufactured by Formlabs Ohio, Inc.. The 510(k) number is K240538.
When was Premium Teeth Resin approved by the FDA?
Premium Teeth Resin received FDA 510(k) clearance on 2024-07-19, under approval number K240538.
What company makes Premium Teeth Resin?
Premium Teeth Resin is manufactured by Formlabs Ohio, Inc..
What is the FDA product code for Premium Teeth Resin?
The FDA product code for Premium Teeth Resin is EBG.
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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.