Opus Bulk Fill APS, Opus Bulk Fill Flow APS
K-Number: K190758 · 2019-09-04
ApplicantDentscare Ltda
Decision Date2019-09-04
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Opus Bulk Fill APS, Opus Bulk Fill Flow APS is a medical device manufactured by Dentscare Ltda. It received FDA 510(k) clearance on 2019-09-04 under approval number K190758. 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 Opus Bulk Fill APS, Opus Bulk Fill Flow APS?
Opus Bulk Fill APS, Opus Bulk Fill Flow APS is a medical device that received FDA 510(k) clearance on 2019-09-04. It is manufactured by Dentscare Ltda. The 510(k) number is K190758.
When was Opus Bulk Fill APS, Opus Bulk Fill Flow APS approved by the FDA?
Opus Bulk Fill APS, Opus Bulk Fill Flow APS received FDA 510(k) clearance on 2019-09-04, under approval number K190758.
What company makes Opus Bulk Fill APS, Opus Bulk Fill Flow APS?
Opus Bulk Fill APS, Opus Bulk Fill Flow APS is manufactured by Dentscare Ltda.
What is the FDA product code for Opus Bulk Fill APS, Opus Bulk Fill Flow APS?
The FDA product code for Opus Bulk Fill APS, Opus Bulk Fill Flow APS is EBF.
Other Devices by Dentscare Ltda
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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.