Home GUDID 00841549108037 ERA ANGLE 3.25MM IMP MICRO HEAD 13X2MM, Ti
Primary DI 00841549108037
Brand ERA ANGLE 3.25MM IMP MICRO HEAD 13X2MM, Ti
Company STERNGOLD DENTAL LLC
Model 901456
Device description Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization. This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles, One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems.
Published 2016-03-02
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 00841549108037 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00841549108037 00841549108037 841549108037 0841549108037
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 Lot or batch true Manufacturing date on label true Expiration date on label true 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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