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510(k) K182228

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments by Mis Implants Technologies , Ltd. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2019
Date Received
August 16, 2018
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 Mis Implants Technologies , Ltd.

  • K180282 — MIS Internal Hex Dental Implant System (June 22, 2018)
  • K173326 — MIS CONNECT Conical Connection Abutment (March 16, 2018)
  • K172505 — MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform C (December 28, 2017)
  • K163349 — MIS V3 Conical Connection Dental Implant System­ (May 26, 2017)
  • K112162 — CONICAL CONNECTION IMPLANTS (August 8, 2012)
  • K110750 — PERIOPATCH (April 28, 2011)
  • K101014 — BOND BONE (October 21, 2010)
  • K092555 — UNO NARROW IMPLANT (January 5, 2010)
  • K080162 — UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT (April 22, 2008)
  • K073461 — ORTHO ANCHOR SCREWS (January 25, 2008)

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