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510(k) K092248

SPI CUSTOMIZABLE GINGIVA FORMER by Thommen Medical AG — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2009
Date Received
July 28, 2009
Clearance Type
Special
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 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)
  • K090154 — SPI DENTAL IMPLANT INICELL (July 27, 2009)
  • K090153 — SPI VARIOMULTI ANGLED ABUTMENT (March 27, 2009)

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