PRESIDENT The Original
K-Number: K220097 · 2022-01-13
ApplicantColtène/Whaledent AG
Decision Date2022-01-13
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
PRESIDENT The Original is a medical device manufactured by Coltène/Whaledent AG. It received FDA 510(k) clearance on 2022-01-13 under approval number K220097. 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 PRESIDENT The Original?
PRESIDENT The Original is a medical device that received FDA 510(k) clearance on 2022-01-13. It is manufactured by Coltène/Whaledent AG. The 510(k) number is K220097.
When was PRESIDENT The Original approved by the FDA?
PRESIDENT The Original received FDA 510(k) clearance on 2022-01-13, under approval number K220097.
What company makes PRESIDENT The Original?
PRESIDENT The Original is manufactured by Coltène/Whaledent AG.
What is the FDA product code for PRESIDENT The Original?
The FDA product code for PRESIDENT The Original is ELW.
Related Devices (Code: ELW)
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.