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510(k) K920768

HOLLOW SCREW IMPLANTS 6MM, 14MM, 16MM by The Straumann Co. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1992
Date Received
February 11, 1992
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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  • K955369 — MEMFIX (January 23, 1996)
  • K941393 — ITI ANGLED ABUTMENT (June 14, 1995)
  • K943720 — ITI TRANSVERSAL SCREWING SYSTEM (March 24, 1995)

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