DCI International, LLC

FDA Device Registration & Listing · NEWBERG, OR, US · Registration 3029780

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3029780
FEI Number
1000523896
Entity Name
DCI International, LLC
City/State/Country
NEWBERG, OR, US
Establishment Address
705 S SPRINGBROOK RD., Bldg C, NEWBERG, OR 97132, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
DCI International LLC (Owner Number: 9099996)
Owner / Operator Contact Address
705 S Springbrook Rd, Bldg. C, Newberg, OR 97132, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NRU Chair, Dental, Without Operative Unit Dental Class 1 872.6250 2015-06-19
ECB Unit, Syringe, Air And/Or Water Dental Class 1 872.4565 2015-06-02
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2024-10-04
EIF Accessories, Retractor, Dental Dental Class 1 872.4565 2023-05-04
EGS Handpiece, Contra- And Right-Angle Attachment, Dental Dental Class 1 872.4200 2024-10-03
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2024-10-03
EAZ Light, Operating, Dental Dental Class 1 872.4630 2015-06-19
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2024-10-03
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2024-10-03
EGS Handpiece, Contra- And Right-Angle Attachment, Dental Dental Class 1 872.4200 2024-10-03
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2025-06-05
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2024-10-03
EGS Handpiece, Contra- And Right-Angle Attachment, Dental Dental Class 1 872.4200 2024-10-03
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2024-10-03
EIA Unit, Operative Dental Dental Class 1 872.6640 2017-05-16
KLC Chair, Dental, With Operative Unit Dental Class 1 872.6250 2017-05-16
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2024-10-07
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2024-10-04
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2024-10-03
NYH Plaque Disclosing Kit Dental Class 2 872.1740 2024-10-03
NBL Laser, Fluorescence Caries Detection Dental Class 2 872.1745 2024-10-03
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2024-10-03

Official Correspondent

Dana Shusterman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DCI International LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243921 Foshan Coxo Medical Instrument Co., Ltd. LED Curing Lights (DB686 HALO) 2025-04-11
K033201 Apoza Enterprise Co., Ltd. LA500 BLUE LIGHT 2003-12-02
K832443 California Technics, Inc. ULTRASONIC DENTAL PROPHYLAXIS UNIT 1983-09-12
K994299 Bonart Co., Ltd. ART-P3, MODEL P3-1-ART-A1 2000-03-06
K212910 Shenzhen Carejoy Technology Co., Ltd. Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece 2022-11-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029780. Last updated year: 2026. Please use registration number 3029780 when referencing this establishment in official correspondence.
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