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510(k) K170261

Premium Plus Prophy Air Motor by Premium Plus International Limited — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2017
Date Received
January 27, 2017
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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