Shaders ZR
K-Number: K190569 · 2019-07-29
ApplicantDigital Age Dental Lab
Decision Date2019-07-29
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Shaders ZR is a medical device manufactured by Digital Age Dental Lab. It received FDA 510(k) clearance on 2019-07-29 under approval number K190569. 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 Shaders ZR?
Shaders ZR is a medical device that received FDA 510(k) clearance on 2019-07-29. It is manufactured by Digital Age Dental Lab. The 510(k) number is K190569.
When was Shaders ZR approved by the FDA?
Shaders ZR received FDA 510(k) clearance on 2019-07-29, under approval number K190569.
What company makes Shaders ZR?
Shaders ZR is manufactured by Digital Age Dental Lab.
What is the FDA product code for Shaders ZR?
The FDA product code for Shaders ZR is EIH.
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.