IPS Style Ceram, IPS Style Ceram One, IPS Style Press
K-Number: K152103 · 2016-05-20
ApplicantIvoclar Vivadent, AG
Decision Date2016-05-20
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
IPS Style Ceram, IPS Style Ceram One, IPS Style Press is a medical device manufactured by Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2016-05-20 under approval number K152103. 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 Style Ceram, IPS Style Ceram One, IPS Style Press?
IPS Style Ceram, IPS Style Ceram One, IPS Style Press is a medical device that received FDA 510(k) clearance on 2016-05-20. It is manufactured by Ivoclar Vivadent, AG. The 510(k) number is K152103.
When was IPS Style Ceram, IPS Style Ceram One, IPS Style Press approved by the FDA?
IPS Style Ceram, IPS Style Ceram One, IPS Style Press received FDA 510(k) clearance on 2016-05-20, under approval number K152103.
What company makes IPS Style Ceram, IPS Style Ceram One, IPS Style Press?
IPS Style Ceram, IPS Style Ceram One, IPS Style Press is manufactured by Ivoclar Vivadent, AG.
What is the FDA product code for IPS Style Ceram, IPS Style Ceram One, IPS Style Press?
The FDA product code for IPS Style Ceram, IPS Style Ceram One, IPS Style Press 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.