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510(k) K241924

Elastic Impression Material by Beijing Okvd Biological Technology , Ltd. — Product Code ELW

K241924 is an FDA 510(k) premarket notification submitted by Beijing Okvd Biological Technology , Ltd. for the device "Elastic Impression Material". The FDA issued a decision of Substantially Equivalent on December 27, 2024. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2024
Date Received
July 1, 2024
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

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FDA data resources