CELTRA Press
K-Number: K161269 · 2016-08-12
ApplicantDentsply Sirona
Decision Date2016-08-12
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
CELTRA Press is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2016-08-12 under approval number K161269. 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 CELTRA Press?
CELTRA Press is a medical device that received FDA 510(k) clearance on 2016-08-12. It is manufactured by Dentsply Sirona. The 510(k) number is K161269.
When was CELTRA Press approved by the FDA?
CELTRA Press received FDA 510(k) clearance on 2016-08-12, under approval number K161269.
What company makes CELTRA Press?
CELTRA Press is manufactured by Dentsply Sirona.
What is the FDA product code for CELTRA Press?
The FDA product code for CELTRA Press is EIH.
Other Devices by Dentsply Sirona
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.