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510(k) K250473

Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus by Dci International, LLC — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2025
Date Received
February 19, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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