BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DCI International, LLC

    Reg #: 3029780 · FEI: 1000523896 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    91
    Establishment Types
    2
    Classifications
    14

    Registration Details

    Registration Name
    DCI International, LLC
    Registration Number
    3029780
    FEI Number
    1000523896
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    705 S SPRINGBROOK RD., Bldg C
    City
    NEWBERG
    State
    OR
    ZIP
    97132
    Country
    US

    Regulatory Submissions

    510(k) Number
    K072181

    Owner / Operator

    Firm Name
    DCI International LLC
    Operator Number
    9099996
    Address
    705 S Springbrook Rd, Bldg. C
    City
    Newberg
    State
    OR
    Postal Code
    97132
    Country
    US
    Correspondent
    Dana Shusterman

    Products

    Device Name Product Code
    Chair, Dental, Without Operative Unit NRU
    Unit, Syringe, Air And/Or Water ECB
    Activator, Ultraviolet, For Polymerization EBZ
    Accessories, Retractor, Dental EIF
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Scaler, Ultrasonic ELC
    Light, Operating, Dental EAZ
    Handpiece, Air-Powered, Dental EFB
    Controller, Foot, Handpiece And Cord EBW
    Unit, Operative Dental EIA
    Chair, Dental, With Operative Unit KLC
    Plaque Disclosing Kit NYH
    Laser, Fluorescence Caries Detection NBL
    Evacuator, Oral Cavity EHZ

    Proprietary Names

    Dental Chair Dental syringe and accessories Kit, Acteon Curing Lt, S4, Light Gray Kit, Acteon Curing Lt, S5 Std Kit, Acteon Curing Lt, S5 Kit, Acteon Curing Lt, Cart Kit, Acteon Curing Lt, S4 Std, White Kit, Acteon Curing Lt, S4, White Kit, Acteon Curing Lt, S4 Std, Light Gray Curing Light, Mini LED, Acteon Mouth Props, Large Adult Mouth Props, Adult Mouth Prop Mouth Props, Child Mouth Props, Edentulous Mouth Props, Small Pedo NSK Electric High Speed M95L Bundle NSK Electric Low Speed Z25L Bundle NSK Electric Low Speed M25L NSK Electric High Speed M95L NSK Electric Low Speed M25L Bundle NSK Electric Low Speed Z25L Ultrasonic Scaler, V6 LED, DTE, Woodpecker Dental LED Light NSK iCare C3 NSK iCare C2 Sub-Assy, NSK w/DCI Display, DCI Display Harness, Series 4 Right Handed Sub-Assy, NSK w/DCI Display and Harness, Mobile, Right Kit, NSK Retrofit, DR Mobile, Left Handed Kit, Motor, Electric, NSK NLZ E, Under Counter DR Kit, NSK Retrofit, DR Mobile, Right Handed Kit, Motor, Electric, NSK NLZ E, Series 4, Right Kit, NSK Retrofit, S4 Delivery Sub-Assy, NSK w/DCI Display and Harness, Mobile, Left Assy, Nsk Display, S5 Dr Kit, Motor, Electric, NSK NLZ E, Mobile DR, Left Sub-Assy, NSK w/DCI Display, NSK Display Harness Kit, Motor, Electric, NSK NLZ E, Side Delivery, Series 5 Kit, Motor, Electric, NSK NLZ E, Series 4, Left Kit, Motor, Electric, NSK NLZ E, Mobile DR, Right Kit, Motor, Electric, NSK NLZ E, Series 5 Motor, Electric, NSK NLZ E Sub-Assy, NSK w/DCI Display, NSK Display Harness, DR5550 Sub-Assy, NSK w/DCI Display, DCI Display Harness Kit, NSK Retrofit, DR Under Counter Kit, NSK Retrofit, S5 Delivery Sub-Assy, NSK w/DCI Display and Harness, NSK AC Adapter Acteon® Newtron LED Piezoelectric Scaler NSK Air High Speed Z890L NSK Air High Speed Z890KL NSK Air High Speed Z990L NSK Air High Speed Z990KL NSK Electric High Speed Z99L Bundle NSK Electric High Speed Z95L NSK Electric High Speed Z95L Bundle NSK Electric High Speed Z99L NSK Air High Speed Z800L NSK Air High Speed Z800L Bundle NSK Air High Speed Z900L Bundle NSK Air High Speed Z800KL Bundle NSK Air High Speed Z900L NSK Air High Speed Z800KL NSK Air High Speed Z900KL Bundle NSK Air High Speed Z900KL Reliance DCI Edge Ultrasonic Scaler, G139 w/Steri-Mate 360, Cavitron Kit, Ultrasonic Scaler, G139 w/Steri-Mate 360, Cavitron Kit, DTE Curing Lt, S4, White Kit, DTE Curing Lt, S4, Light Gray Kit, DTE Curing Lt, S4 Std, White Kit, DTE Curing Lt, S4 Std, Light Gray Kit, DTE Curing Lt, S5 Curing Light, LED. G, Woodpecker Kit, DTE Curing Lt, S5 Std Kit, DTE Curing Lt, Cart NSK Air Low Speed iProphy Air Bundle Kit, Mini Dock U-USB2, w/o Camera, Acteon, Series 5, Light Gray Kit, Mini Dock U-USB2, w/o Camera, Acteon, Light Gray Mini Dock U-USB2, Light Gray, Intra-Oral Camera, Acteon Kit, Mini Dock U-USB2, w/o Camera, Acteon, White NSK Air High Speed M800L Bundle NSK Air High Speed M900L NSK Air High Speed M800L NSK Air High Speed Coupler PTL-CL-LED NSK Air High Speed M900L Bundle DCI DENTAL UNIT & ACCESSORIES Dental Delivery System Series 5 and 5 Plus NSK Air Low Speed FX25 Bundle NSK Air Low Speed FX57 Bundle HVE and SE

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device