IPS e.max One
K-Number: K211916 · 2021-08-20
ApplicantIvoclar Vivadent, AG
Decision Date2021-08-20
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
IPS e.max One is a medical device manufactured by Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2021-08-20 under approval number K211916. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IPS e.max One?
IPS e.max One is a medical device that received FDA 510(k) clearance on 2021-08-20. It is manufactured by Ivoclar Vivadent, AG. The 510(k) number is K211916.
When was IPS e.max One approved by the FDA?
IPS e.max One received FDA 510(k) clearance on 2021-08-20, under approval number K211916.
What company makes IPS e.max One?
IPS e.max One is manufactured by Ivoclar Vivadent, AG.
What is the FDA product code for IPS e.max One?
The FDA product code for IPS e.max One is EIH.
Other Devices by Ivoclar Vivadent, AG
Related Devices (Code: EIH)
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.