DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)
K-Number: K212254 · 2021-10-19
ApplicantHdx Will Corp.
Decision Date2021-10-19
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) is a medical device manufactured by Hdx Will Corp.. It received FDA 510(k) clearance on 2021-10-19 under approval number K212254. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)?
DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) is a medical device that received FDA 510(k) clearance on 2021-10-19. It is manufactured by Hdx Will Corp.. The 510(k) number is K212254.
When was DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) approved by the FDA?
DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) received FDA 510(k) clearance on 2021-10-19, under approval number K212254.
What company makes DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)?
DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) is manufactured by Hdx Will Corp..
What is the FDA product code for DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)?
The FDA product code for DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) is OAS.
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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.