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510(k) K080598

MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS by Intra-Lock International — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2008
Date Received
March 3, 2008
Clearance Type
Abbreviated
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 Intra-Lock International

  • K171831 — Intra-Lock Bone Fixation System (October 26, 2017)
  • 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)
  • 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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