MOR® Implant 3.0 X 15mm, Ti

GUDID 00841549108266

The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation. The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants 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 or partial edentulous cases, and employing minimally invasive surgical intervention.

STERNGOLD DENTAL LLC

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Primary Device ID00841549108266
NIH Device Record Key0ae03507-dcab-4e8c-8ad3-e340fec41ad7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMOR® Implant 3.0 X 15mm, Ti
Version Model Number901492
Company DUNS124763728
Company NameSTERNGOLD DENTAL LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841549108266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-08
Device Publish Date2020-05-29

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