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510(k) K242611

Integral Dental Units by Mipont Medical Equipment Co., Ltd. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2025
Date Received
September 3, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

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