Home GUDID 00841549119064 Sterngold Implant System Guided Tissue Punch 3.5
Primary DI 00841549119064
Brand Sterngold Implant System Guided Tissue Punch 3.5
Company STERNGOLD DENTAL LLC
Model 905813
Device description Removes gingival tissue exposing the bone in preparation for osteotomy drilling.
Published 2023-06-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name EME Punch, Biopsy, Surgical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EME Punch, Biopsy, Surgical Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841549119064 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 00841549119064 00841549119064 841549119064 0841549119064
GMDN Terms# Term, Definition table Term Definition Fixture/appliance dental drill bit, reusable A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 124763728 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use 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
Other Devices Sharing Product Codes# 
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