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510(k) K130140

INTRA-LOCK OP DENTAL IMPLANT by Intra-Lock International — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2013
Date Received
January 22, 2013
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

Other clearances by Intra-Lock International

  • K171831 — Intra-Lock Bone Fixation System (October 26, 2017)
  • K133613 — INTRA-LOCK DENTAL IMPLANTS (March 20, 2014)
  • K111199 — INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS (August 8, 2011)
  • K103194 — INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM (April 21, 2011)
  • K082419 — REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 (May 27, 2009)
  • K080598 — MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS (May 21, 2008)
  • K070601 — MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM (October 12, 2007)
  • K050970 — MILO DENTAL IMPLANT SYSTEM (October 14, 2005)
  • K040205 — INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS (March 22, 2004)
  • K031322 — INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS (December 23, 2003)

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