ACTIVA PRESTO PACK
K-Number: K210045 · 2021-09-22
ApplicantPulpdent Corporation
Decision Date2021-09-22
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ACTIVA PRESTO PACK is a medical device manufactured by Pulpdent Corporation. It received FDA 510(k) clearance on 2021-09-22 under approval number K210045. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ACTIVA PRESTO PACK?
ACTIVA PRESTO PACK is a medical device that received FDA 510(k) clearance on 2021-09-22. It is manufactured by Pulpdent Corporation. The 510(k) number is K210045.
When was ACTIVA PRESTO PACK approved by the FDA?
ACTIVA PRESTO PACK received FDA 510(k) clearance on 2021-09-22, under approval number K210045.
What company makes ACTIVA PRESTO PACK?
ACTIVA PRESTO PACK is manufactured by Pulpdent Corporation.
What is the FDA product code for ACTIVA PRESTO PACK?
The FDA product code for ACTIVA PRESTO PACK is EBF.
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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.