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510(k) K931993

ITI DISTANCE SYSTEM by The Straumann Co. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1994
Date Received
April 23, 1993
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

Other clearances by The Straumann Co.

  • K041070 — STRAUMANN TEMPORARY COPING (July 23, 2004)
  • K040646 — STRAUMANN GRANULES (May 3, 2004)
  • K040469 — THE STRAUMANN ORTHO IMPLANT SYSTEM (April 30, 2004)
  • K993862 — MODUS SAGITTAL SPLIT PLATE (December 29, 1999)
  • K962023 — PLASTIC PROTECTION HEALING CAPS (August 15, 1996)
  • K960634 — TITANIUM HEALING CAPS (June 18, 1996)
  • K955281 — ENDOSSEOUS DENTAL IMPLANT & ACCESSORIES (March 15, 1996)
  • K955369 — MEMFIX (January 23, 1996)
  • K941393 — ITI ANGLED ABUTMENT (June 14, 1995)
  • K943720 — ITI TRANSVERSAL SCREWING SYSTEM (March 24, 1995)

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