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510(k) K180682

AeroPro Cordless Prophy System by Premier Dental Company Products — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2019
Date Received
March 15, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Direct Drive, Ac-Powered
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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