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510(k) K041070

STRAUMANN TEMPORARY COPING by The Straumann Co. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2004
Date Received
April 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abutment, Implant, Dental, Endosseous
Device Class
Class II
Regulation Number
872.3630
Review Panel
DE
Submission Type

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Other clearances by The Straumann Co.

  • 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)
  • K931993 — ITI DISTANCE SYSTEM (April 26, 1994)

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  • K243732 — Multi-Unit DAS System (January 29, 2026)
  • K253253 — IPDmilled Blanks (January 22, 2026)
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  • K252727 — Neodent InLab Validated Workflow (January 7, 2026)
  • K253341 — Custom Abutments AS (December 23, 2025)
  • K253312 — OrangeCAD Med Abutments (December 23, 2025)
  • K252320 — SIMDA Abutments (December 18, 2025)