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510(k) K102308

SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS by Dentium Co., Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2010
Date Received
August 16, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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  • K161713 — Dentium CAD/CAM Abutments (December 16, 2016)

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