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510(k) K034035

3I PATIENT-SPECIFIC OVERDENTURE BAR by Implant Innovations, Inc. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2004
Date Received
December 29, 2003
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 Implant Innovations, Inc.

  • K062636 — OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICR (June 1, 2007)
  • K063341 — 3I OSSEOTITE CERTAIN DENTAL IMPLANTS (April 30, 2007)
  • K063286 — OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE (April 24, 2007)
  • K063403 — CONICAL ANGLED ABUTMENT (March 20, 2007)
  • K061629 — CERTAIN PREVAIL DENTAL IMPLANT (February 23, 2007)
  • K062432 — NANOTITE DENTAL IMPLANTS (February 22, 2007)
  • K061969 — PREFORMANCE POSTS AND TEMPORARY CYLINDERS (July 21, 2006)
  • K061177 — PROVIDE TEMPORARY CYLINDER (May 16, 2006)
  • K060291 — PREFORMANCE TEMPORARY CYLINDER (February 27, 2006)
  • K053170 — PREFORMANCE POSTS (February 1, 2006)

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