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510(k) K946198

IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR by Sterngold — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1995
Date Received
December 20, 1994
Clearance Type
Traditional
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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