SprintRay High Impact Denture Base
K-Number: K221678 · 2022-11-10
ApplicantSprintray, Inc.
Decision Date2022-11-10
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SprintRay High Impact Denture Base is a medical device manufactured by Sprintray, Inc.. It received FDA 510(k) clearance on 2022-11-10 under approval number K221678. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SprintRay High Impact Denture Base?
SprintRay High Impact Denture Base is a medical device that received FDA 510(k) clearance on 2022-11-10. It is manufactured by Sprintray, Inc.. The 510(k) number is K221678.
When was SprintRay High Impact Denture Base approved by the FDA?
SprintRay High Impact Denture Base received FDA 510(k) clearance on 2022-11-10, under approval number K221678.
What company makes SprintRay High Impact Denture Base?
SprintRay High Impact Denture Base is manufactured by Sprintray, Inc..
What is the FDA product code for SprintRay High Impact Denture Base?
The FDA product code for SprintRay High Impact Denture Base is EBI.
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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.