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510(k) K240966

Prima Plus Conical Implant System by Keystone Dental, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2024
Date Received
April 9, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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

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