Home / 510(k) Clearances / K090154

510(k) K090154

SPI DENTAL IMPLANT INICELL by Thommen Medical AG — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2009
Date Received
January 22, 2009
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 Thommen Medical AG

  • K171795 — Thommen Implant System (September 29, 2017)
  • K160244 — VARIOunite (June 2, 2016)
  • K151984 — Thommen Milling Abutment for CAD/CAM (March 10, 2016)
  • K121334 — VARIOECO (August 14, 2012)
  • K111984 — SPI VARIO ANGLED ABUTMENT (November 10, 2011)
  • K102804 — SPI TITANIUM BASE FOR CAD/CAM (April 20, 2011)
  • K101798 — SPI VARIOMULTI ANGLED ABUTMENT (August 19, 2010)
  • K093615 — SPI DENTAL IMPLANT, ELEMENT (March 4, 2010)
  • K092248 — SPI CUSTOMIZABLE GINGIVA FORMER (September 25, 2009)
  • K090153 — SPI VARIOMULTI ANGLED ABUTMENT (March 27, 2009)

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)