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510(k) K080239

P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS by Straumann Manufacturing, Inc. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2008
Date Received
January 31, 2008
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 Straumann Manufacturing, Inc.

  • K092814 — STRAUMANN DENTAL ABUTMENTS (December 15, 2009)
  • K090260 — MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS (February 26, 2009)
  • K070478 — P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP) (September 20, 2007)

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