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510(k) K063341

3I OSSEOTITE CERTAIN DENTAL IMPLANTS by Implant Innovations, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2007
Date Received
November 6, 2006
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 Implant Innovations, Inc.

  • K062636 — OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICR (June 1, 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)
  • K052648 — MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS (October 20, 2005)

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