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510(k) K122424

ISUS IMPLANT SUPRASTRUCTURES by Dentsply International, Inc. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2013
Date Received
August 9, 2012
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 Dentsply International, Inc.

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  • K152247 — ATLANTIS Crown (January 29, 2016)
  • K151039 — ATLANTIS Abutment for NobelActive 3.0 (January 14, 2016)
  • K151619 — Prime&Bond Elect Universal Dental Adhesive (October 30, 2015)
  • K150535 — Cavitron Touch Ultrasonic Scaling System (June 16, 2015)
  • K142178 — PROROOT MTA WHITE, PROROOT MTA GRAY (February 26, 2015)
  • K131907 — RAYPEX 6 (January 31, 2014)
  • K131644 — ANKYLOS SYNCONE ABUTMENT 5(DEGREE) (January 22, 2014)

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