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510(k) K081653

MDI MII ONE-PIECE IMPLANT, 2.9MM by Imtec Corp. — Product Code DZE

K081653 is an FDA 510(k) premarket notification submitted by Imtec Corp. for the device "MDI MII ONE-PIECE IMPLANT, 2.9MM". The FDA issued a decision of Substantially Equivalent on September 19, 2008. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Imtec Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2008
Date Received
June 12, 2008
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 Imtec Corp.

  • K081347 — ILUMA VISION (May 28, 2008)
  • K072660 — ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 (December 12, 2007)
  • K053046 — ILUMA ORTHOCAT/DENTALCAT (November 8, 2005)
  • K043226 — ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 (January 13, 2005)
  • K042289 — MDI ORTHO (September 15, 2004)
  • K033432 — LEXATITE QUICK ACRYLIC (January 15, 2004)
  • K031106 — IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, M (August 12, 2003)
  • K030243 — ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 (April 23, 2003)
  • K024044 — SABER TECH IMPLANTS SYSTEM (February 21, 2003)
  • K023067 — IMTEC SENDAX MDI ORTHO6 AND ORTHO8 (December 3, 2002)

Other clearances for product code DZE

  • K251188 — UNIQA® Dental Implants System (June 25, 2026)
  • K251232 — MegaGen Zygoma Dental Implant System (June 18, 2026)
  • K250806 — Dental Implant System (June 18, 2026)
  • K260006 — INOSS System (June 17, 2026)
  • K252731 — Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implan (May 12, 2026)
  • K252031 — Adin Long Dental Implant System (March 23, 2026)
  • K253334 — ZENEX Implant System_Short (R-System) (March 16, 2026)
  • 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)

FDA data resources