Titanium coping for IT1 anterior implant

Titanium coping for IT1 anterior implant
Summary Information:
ApplicantÇƒÙs Name and Address
Straumann USA (on behalf of lnstitut Straumann AG)
Reservoir Place
1601 Trapelo Road
Waltham, MA 02451
Telephone Number: 781 -890-0001
Fax Number: 781 -890-6464
Contact Person: Linda Jalbert
Director, Regulatory Affairs
Name of the Device
Trade Name: Titanium coping for IT1 anterior implant
Common Name: Endosseous dental implants
Classification Name: Endosseous dental implants
21 CFR 872.3640
Description of the Device
The IT1 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially, or fully edentulous patients. The system consists of a variety of
dental implants, abutments, and surgical and prosthetic parts and instruments. The devices covered by this submission are titanium angled copings for the IT1 anterior implant.
Intended Use of the Device
The IT1 Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices (crowns, bridges, and overdentures) for partially and fully edentulous patients. The system consists of a variety of dental implants, abutments, copings and other surgical and prosthetic parts and instruments.
The device that is the subject of this submission is an angled titanium coping, which is a pre-manufactured component offering a pre-formed inner surface for mating with the dental implant abutment. The outer
surface of the coping is adapted to the individual restoration.