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510(k) K192913

R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2021
Date Received
October 15, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

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