Search Results
Found 23 results
510(k) Data Aggregation
K Number
K081653Device Name
MDI MII ONE-PIECE IMPLANT, 2.9MM
Manufacturer
IMTEC CORP.
Date Cleared
2008-09-19
(99 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMTEC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MII Implant is intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches. The MII implant is indicated for immediate loading when good primary stability is achieved. Additionally, this device will permit stability and long term fixation of upper and lower dentures in edentulous cases.
Device Description
The IMTEC MDI MII 2.9mm one-piece implant is a one piece endosseous dental implant that is a combination of implant and abutment sections. The thread lengths are 10mm, 13mm, 15mm, and 18mm. The implant is composed of Titanium alloy. The MDI MII body has a thread design for bone compression and the implant tip is equipped with our patent pending auto advancing cutting threads similar to those found on the IMTEC Endure Implant system. The implant section surface is blasted & etched to facilitate osseointegration. In addition, the implant has micro-threads at the intra-osseous collar to preserve crestal bone. It has a transgingival collar 2mm in height that includes a platform switching groove for soft tissue stability. The Implant has two prosthetic head design options, O-ball and Tapered Abutment design. The O-ball head on the MDI MII is identical to the O-ball head on the IMTEC MDI implant. Both are designed for fixed and removable applications. The abutment portion of the MII implant is coated with Titanium Nitride.
Ask a Question
K Number
K081347Device Name
ILUMA VISION
Manufacturer
IMTEC CORP.
Date Cleared
2008-05-28
(14 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
IMTEC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ILUMA VISION is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound. It is intended for use by radiologist, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis and distribute DICOM 3.0 compliant images, utilizing standard PC hardware. Additionally, ILUMA Vision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments. The device is not intended for use with mammography.
Device Description
Not Found
Ask a Question
K Number
K072660Device Name
ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114
Manufacturer
IMTEC CORP.
Date Cleared
2007-12-12
(82 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMTEC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K053046Device Name
ILUMA ORTHOCAT/DENTALCAT
Manufacturer
IMTEC CORP.
Date Cleared
2005-11-08
(11 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
IMTEC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IMTEC Imaging ILUMA™ OrthoCat™ and DentalCat™ are x-ray devices (cone beam computed tomography) that acquire a single 360° rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support.
Device Description
x-ray devices (cone beam computed tomography) that acquire a single 360° rotational sequence
Ask a Question
K Number
K043226Device Name
ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320
Manufacturer
IMTEC CORP.
Date Cleared
2005-01-13
(52 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMTEC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To replace missing tooth roots for single tooth, partial tooth, and fully edentulous patients. ENDURE endosseous implants are designed to become an Osseointegrated prosthesis allowing the attachment of a partial or a complete prosthodontic appliance in the mandible or maxilla.
Device Description
Not Found
Ask a Question
K Number
K042289Device Name
MDI ORTHO
Manufacturer
IMTEC CORP.
Date Cleared
2004-09-15
(22 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMTEC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Implants are intended for single use only.
Device Description
Not Found
Ask a Question
K Number
K033432Device Name
LEXATITE QUICK ACRYLIC
Manufacturer
IMTEC CORP.
Date Cleared
2004-01-15
(79 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
IMTEC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LEXATITE QUICK ACRYLIC is intended for use as a self-curing, cold-curing, resin for LEAATTE QUORTAON crowns, bridges, inlays and onlays.
Device Description
Not Found
Ask a Question
K Number
K031106Device Name
IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX
Manufacturer
IMTEC CORP.
Date Cleared
2003-08-12
(126 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMTEC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MDI and MDI PLUS are self-tapping titanium threaded screws indicated for long-term intra-bony applications. Additionally, the MDI may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full partial endentulism, and employing minimally invasive surgical intervention.
Device Description
self-tapping titanium threaded screws
Ask a Question
K Number
K030243Device Name
ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314
Manufacturer
IMTEC CORP.
Date Cleared
2003-04-23
(90 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMTEC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To replace missing tooth roots for single tooth, partial tooth, and fully edentulous patients. ENDURE endosseous implants are designed to become an Osseointegrated prosthesis allowing the attachment of a partial or a complete prosthodentic appliance in the mandible or maxilla.
Device Description
ENDURE endosseous implant
Ask a Question
K Number
K024044Device Name
SABER TECH IMPLANTS SYSTEM
Manufacturer
IMTEC CORP.
Date Cleared
2003-02-21
(77 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMTEC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To serve as artificial root structures for single teeth or bridge abutments for bridgework in edentulous sites with adequate bone of sufficient quality to support the implant and function.
Device Description
Saber Tech Implants System (GIS) endosseous implant
Ask a Question
Page 1 of 3