Home / 510(k) Clearances / K032263

510(k) K032263

3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR by Implant Innovations, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2004
Date Received
July 23, 2003
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)
  • 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)

Other clearances for product code DZE

  • K252168 — Straumann® BLC Implants - Indication Widening (March 10, 2026)
  • K253493 — Dentis SQ-SL AXEL Fixture (March 4, 2026)
  • K252197 — Nobel Biocare S Series Implants (February 18, 2026)
  • K252286 — BIORES Dental Implant System (February 2, 2026)
  • K252585 — ZENEX Implant System_R-System (January 8, 2026)
  • K250476 — NizPlant Dental Implant System (December 23, 2025)
  • K252145 — GEN5™ and GEN5+™ 3.3mmD Dental Implants (December 23, 2025)
  • K251605 — DIMPLO Implant System (December 22, 2025)
  • K252090 — Pterygoid Indication for GM Helix Implants (December 12, 2025)
  • K251129 — S.I.N. Tapered Pro Conical Zygoma Implant System (November 7, 2025)