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510(k) K860653

PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT by Otc/America — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1986
Date Received
February 21, 1986
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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