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FDA 510(k)

AeroPro Cordless Prophy System

K-Number: K180682 · 2019-02-27

Decision Date2019-02-27
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AeroPro Cordless Prophy System is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Company Products. It received FDA 510(k) clearance on 2019-02-27 under 510(k) 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. The listed applicant is Premier Dental Company Products. The 510(k) number is K180682.

When did AeroPro Cordless Prophy System receive FDA 510(k) clearance?

AeroPro Cordless Prophy System received FDA 510(k) clearance on 2019-02-27, under 510(k) number K180682.

Who is the listed applicant for AeroPro Cordless Prophy System?

The FDA 510(k) record lists Premier Dental Company Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AeroPro Cordless Prophy System?

The FDA product code for AeroPro Cordless Prophy System is EKX.

Other records listing Premier Dental Company Products as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: EKX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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