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510(k) K092814

STRAUMANN DENTAL ABUTMENTS by Straumann Manufacturing, Inc. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2009
Date Received
September 14, 2009
Clearance Type
Special
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 Straumann Manufacturing, Inc.

  • K090260 — MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS (February 26, 2009)
  • K080239 — P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANEN (April 30, 2008)
  • K070478 — P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP) (September 20, 2007)

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