FDA 510(k)

StoneBite and StoneBite scan

K-Number: K190571 · 2019-11-07

Decision Date2019-11-07

Product CodeELW

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

StoneBite and StoneBite scan is a medical device manufactured by Dreve Dentamid GmbH. It received FDA 510(k) clearance on 2019-11-07 under approval number K190571. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StoneBite and StoneBite scan?

StoneBite and StoneBite scan is a medical device that received FDA 510(k) clearance on 2019-11-07. It is manufactured by Dreve Dentamid GmbH. The 510(k) number is K190571.

When was StoneBite and StoneBite scan approved by the FDA?

StoneBite and StoneBite scan received FDA 510(k) clearance on 2019-11-07, under approval number K190571.

What company makes StoneBite and StoneBite scan?

StoneBite and StoneBite scan is manufactured by Dreve Dentamid GmbH.

What is the FDA product code for StoneBite and StoneBite scan?

The FDA product code for StoneBite and StoneBite scan is ELW.

Other Devices by Dreve Dentamid GmbH

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.