AeroPro Cordless Prophy System
K-Number: K180682 · 2019-02-27
ApplicantPremier Dental Company Products
Decision Date2019-02-27
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
AeroPro Cordless Prophy System is a medical device manufactured by Premier Dental Company Products. It received FDA 510(k) clearance on 2019-02-27 under approval number K180682. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AeroPro Cordless Prophy System?
AeroPro Cordless Prophy System is a medical device that received FDA 510(k) clearance on 2019-02-27. It is manufactured by Premier Dental Company Products. The 510(k) number is K180682.
When was AeroPro Cordless Prophy System approved by the FDA?
AeroPro Cordless Prophy System received FDA 510(k) clearance on 2019-02-27, under approval number K180682.
What company makes AeroPro Cordless Prophy System?
AeroPro Cordless Prophy System is manufactured by Premier Dental Company Products.
What is the FDA product code for AeroPro Cordless Prophy System?
The FDA product code for AeroPro Cordless Prophy System is EKX.
Other Devices by Premier Dental Company Products
Related Devices (Code: EKX)
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.