Dia-X Bond Universal
K-Number: K220804 · 2022-06-15
ApplicantDiaDent Group International
Decision Date2022-06-15
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Dia-X Bond Universal is a medical device manufactured by DiaDent Group International. It received FDA 510(k) clearance on 2022-06-15 under approval number K220804. 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 Dia-X Bond Universal?
Dia-X Bond Universal is a medical device that received FDA 510(k) clearance on 2022-06-15. It is manufactured by DiaDent Group International. The 510(k) number is K220804.
When was Dia-X Bond Universal approved by the FDA?
Dia-X Bond Universal received FDA 510(k) clearance on 2022-06-15, under approval number K220804.
What company makes Dia-X Bond Universal?
Dia-X Bond Universal is manufactured by DiaDent Group International.
What is the FDA product code for Dia-X Bond Universal?
The FDA product code for Dia-X Bond Universal 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.