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510(k) K882578

ASTRA DENTAL IMPLANT SYSTEM by Astra Meditec AB — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1988
Date Received
June 22, 1988
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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