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510(k) K251869

Disposable Prophy Angle (3399-60, 3399-090, 3399-105) by Premium Plus (Dongguan) Limited — Product Code EGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2025
Date Received
June 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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