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510(k) K253052

Fluoride Varnish (Type A,Type C) by Nagy Oral Technology Qinhuangdao Co., Ltd. — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2026
Date Received
September 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Varnish, Cavity
Device Class
Class II
Regulation Number
872.3260
Review Panel
DE
Submission Type

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