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510(k) K221381

KDG Abutments by Keystone Dental, Inc. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2022
Date Received
May 13, 2022
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.

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  • K101545 — GENESIS IMPLANT SYSTEM (October 28, 2010)
  • K090397 — XPI ANGLED ABUTMENTS (June 5, 2009)
  • K071070 — OLYMPUS DENTAL IMPLANT SYSTEM (October 23, 2007)
  • K071599 — EASYGUIDE (July 11, 2007)

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