Mdi Mii One-Piece Implant, 2.9MM

• • Terminated Z-1997-2009 FDA Unclassified (pre-2012) ·initiated 7 Jul 2009 ·on shared 510(k) K081653

  Size printed on product packaging does not match size of enclosed product.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K081653 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Imtec/Titanium Mesh

  Class II

  FDA 510(k) K970841 Active Cleared 30 Apr 1997

• Endure Implant, Model 5108, 5111, 5113, 5114

  Class II

  FDA 510(k) K072660 Active Cleared 12 Dec 2007

• Secure Soft

  Class II

  FDA 510(k) K021437 Active Cleared 19 Jul 2002

• Hexlock/Hexlock Screw

  Class II

  FDA 510(k) K932168 Active Cleared 24 Aug 1994

• Imtec Bone Collector System

  Class I

  FDA 510(k) K973248 Active Cleared 19 Nov 1997

• Biocellect -Perio

  Class II

  FDA 510(k) K020396 Active Cleared 10 Apr 2002

See all devices from Imtec Corp. →

• What is the primary purpose of the MDI MII One-Piece Implant?

  This device is specifically intended for the stabilization of full dentures in both the mandible and the maxilla. By acting as an endosseous dental implant, it provides a secure foundation for removable prosthetic appliances.

• How is the MDI MII implant constructed?

  The implant is manufactured as a single unit that integrates both the implant and abutment sections. It is made from a titanium alloy and features a blasted and etched surface to facilitate osseointegration, along with micro-threads at the collar to help preserve crestal bone.

• What are the physical dimensions of this implant?

  The MDI MII One-Piece Implant is supplied as a 2.9mm diameter unit. This specific size is designed to meet the requirements for the stabilization of full dentures as outlined in the device specifications.

• What is the regulatory status of this dental implant?

  The MDI MII One-Piece Implant has received FDA 510k clearance. It was processed under the traditional submission route and determined to be substantially equivalent to existing devices within the dental product category.