BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sterngold Dental LLC

    Reg #: 2921595 · FEI: 2921595 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    60
    Establishment Types
    2
    Classifications
    15

    Registration Details

    Registration Name
    Sterngold Dental LLC
    Registration Number
    2921595
    FEI Number
    2921595
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    23 Frank Mossberg Drive
    City
    Attleboro
    State
    MA
    ZIP
    02703
    Country
    US

    Regulatory Submissions

    510(k) Number
    K962301

    Owner / Operator

    Firm Name
    Sterngold
    Operator Number
    10023675
    Address
    23 Frank Mossberg Drive
    City
    Attleboro
    State
    MA
    Postal Code
    02703
    Country
    US
    Correspondent
    Laura L Greige

    Products

    Device Name Product Code
    Alloy, Other Noble Metal EJS
    Implant, Endosseous, Root-Form DZE
    Alloy, Gold-Based Noble Metal EJT
    Instrument, Filling, Plastic, Dental EIY
    Material, Impression ELW
    Material, Impression Tray, Resin EBH
    Crown And Bridge, Temporary, Resin EBG
    Post, Root Canal ELR
    Cement, Dental EMA
    Accessories, Implant, Dental, Endosseous NDP
    Abutment, Implant, Dental, Endosseous NHA
    Attachment, Precision, All EGG
    Material, Tooth Shade, Resin EBF
    Sealant, Pit And Fissure, And Conditioner EBC
    Resin, Denture, Relining, Repairing, Rebasing EBI

    Proprietary Names

    Sterngold G-Hard Stern ERA Resilient Dental System Implamed Implant System Implamed Hex Screw Implants, 18mm and 20mm ERA Implant Stern ERA Alignment Correction Implant Abutment Implamed Hex Screw Implants, 4.5mm and 6mm Diameter ERA Pickup Mixing Tips Stern Vantage SternTek Custom Tray Impression Material Stern Tek Duplicating Material Instatemp Max Stern Root Anchor System Tempolock Titanium & Stainless Steel Instruments Screw Drivers, Hex Drivers, Seating Tools, Implant Mount, Depth Probe, Ratchet Wr Sterngold Dental Narrow Platform Dental Implants, Related Prosthetics & Instruments ERA Dental Implant System Sterngold Dental Instruments Sterngold Dental Accessories SFI Abutments Platforms BD BE BF AE AN AP AY AJ AK Criterion Acid Etch Implant System Sterngold Bio-H & Bio-C Stern Snap 0 Degree Attachment SternOmega Sern IC Dental Implant System Pegasus Phoenix & 2713 Pegasus Dental Alloy 3340109 Blue Friction Sleeves 3340108 TDI Yellow Pins 3340104 Red Friction Sleeves Implamed UCLA Type Abutments and Accessories PUR Dental Implant System Titanium & Stainless Steel Dental Implant Drill, Countersinks, Bone Taps, Marking burs MOR Dental Implant System MOR 3mm and PUR 3.2mm Implant Systems, Mor 2.1x18mm and MOR 2.4x18mm Implants Omegaflo Sterngold Bio-4 EZ Pickup Material Sterngold Implamed Hex Screw Implant TPS and HA Coated Stern Omega Micro ERA System Stern 1 Galaxy Stern AC Dental Implant System Implamed Low Margin Abutments Apollo ORA Implant Abutments Stern 66 23 Deg and 30 Deg ERA Female Abutment Quickline/Instagums 2.2mm Angled Micro ERA Dental Implant System Sterngold Implamed Wide Platform Dental Implants, Prosthetics and Instruments 6AL-4V Dental Implants, Abutments and Components TRU Dental Implant Stern Snap Angled Abutment Sterngold M-PF ERA Implant Abutment SFI Bar Implant Abutment

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device