Allcem, Allcem Core
K-Number: K183465 · 2019-11-02
ApplicantDentscare Ltda
Decision Date2019-11-02
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Allcem, Allcem Core is a medical device manufactured by Dentscare Ltda. It received FDA 510(k) clearance on 2019-11-02 under approval number K183465. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Allcem, Allcem Core?
Allcem, Allcem Core is a medical device that received FDA 510(k) clearance on 2019-11-02. It is manufactured by Dentscare Ltda. The 510(k) number is K183465.
When was Allcem, Allcem Core approved by the FDA?
Allcem, Allcem Core received FDA 510(k) clearance on 2019-11-02, under approval number K183465.
What company makes Allcem, Allcem Core?
Allcem, Allcem Core is manufactured by Dentscare Ltda.
What is the FDA product code for Allcem, Allcem Core?
The FDA product code for Allcem, Allcem Core is EMA.
Other Devices by Dentscare Ltda
Related Devices (Code: EMA)
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.