Home GUDID 08415491156242 MOR Implant 2.1 x 13mm, Ti
Primary DI 08415491156242
Brand MOR Implant 2.1 x 13mm, Ti
Company STERNGOLD DENTAL LLC
Model 901481
Device description 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.
Published 2016-03-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name DZE Implant, Endosseous, Root-Form
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DZE Implant, Endosseous, Root-Form Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08415491156242 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08415491156242 08415491156242 8415491156242
GMDN Terms# Term, Definition table Term Definition Dental implant suprastructure, permanent, preformed A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.
Regulatory Flags# DUNS number 124763728 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00841549118517 SternTek Duplicating Material 222012 2023-10-04 00841549101823 ERA® DO LP Basic Kit w/ Tools SS 811412 2020-07-07 00841549115042 Sterngold Implant System Cortical Bone Drill 3.2mm 905522 2020-07-07 00841549103841 ERA® Implant Abutment Micro 0°, 4mm Cuff (AX) 812435 2017-03-21 00841549103889 ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (BD) 812532 2017-03-21 00841549103896 ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (BD) 812533 2017-03-21 00841549103902 ERA® Implant Abutment Micro Ang. Base, 4mm Cuff (BD) 812534 2017-03-21 00841549103919 ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (BD) 812535 2017-03-21 00841549103926 ERA® Implant Abutment Micro Ang. Base, 6mm Cuff (BD) 812536 2017-03-21 00841549103933 ERA® Implant Abutment Micro 0°, 0.5mm Cuff (BD) 812537 2017-03-21 00841549103940 ERA® Implant Abutment Micro 0°, 2mm Cuff (BD) 812538 2017-03-21 00841549103957 ERA® Implant Abutment Micro 0°, 3mm Cuff (BD) 812539 2017-03-21 00841549103964 ERA® Implant Abutment Micro 0°, 4mm Cuff (BD) 812540 2017-03-21 00841549103988 ERA® Implant Abutment Micro 0°, 6mm Cuff (BD) 812542 2017-03-22 00841549103995 ERA® Implant Abutment Micro Ang. Base, 1mm Cuff (BE) 812543 2017-03-22 00841549104008 ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (BE) 812544 2017-03-22 00841549104015 ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (BE) 812545 2017-03-22 00841549104022 ERA® Implant Abutment Micro Ang. Base, 4mm Cuff (BE) 812546 2017-03-22 00841549104039 ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (BE) 812547 2017-03-22 00841549104046 ERA® Implant Abutment Micro Ang. Base, 6mm Cuff (BE) 812548 2017-03-22
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