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510(k) K042828

OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 by Young O/S, LLC — Product Code EKR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2004
Date Received
October 12, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plugger, Root Canal, Endodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

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  • K791019 — MCSPADDEN CONDENSOR (August 3, 1979)