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510(k) K171831

Intra-Lock Bone Fixation System by Intra-Lock International, Inc. — Product Code DZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2017
Date Received
June 20, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Intraosseous
Device Class
Class II
Regulation Number
872.4880
Review Panel
DE
Submission Type

Other clearances by Intra-Lock International, Inc.

  • K133613 — INTRA-LOCK DENTAL IMPLANTS (March 20, 2014)
  • K130140 — INTRA-LOCK OP DENTAL IMPLANT (August 1, 2013)
  • 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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