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510(k) K143505

Zimmer Patient-Specific Abutment, Internal Hex, Titanium by Zimmer Dental, Inc. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2015
Date Received
December 10, 2014
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 Zimmer Dental, Inc.

  • K160398 — MRI Compatibility for Existing Zimmer Dental Implant Systems (May 17, 2017)
  • K143528 — Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System (May 1, 2015)
  • K142572 — Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System (January 21, 2015)
  • K142082 — ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR AB (October 28, 2014)
  • K141544 — ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM (October 22, 2014)
  • K141120 — ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM (July 29, 2014)
  • K133551 — ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM (July 18, 2014)
  • K134045 — ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE I (April 25, 2014)
  • K133339 — ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCRE (March 4, 2014)
  • K132258 — ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM (November 19, 2013)

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