Data / Medical devices / United States / DCI International, LLC

DCI International, LLC: FDA-registered device maker in Newberg, OR, United States, 18 510(k) clearances

Name: DCI International, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

DCI International, LLC is registered with the FDA (registration 3029780) in Newberg, OR, United States. It lists 14 device types. The FDA files 18 510(k) clearances under its listings, the newest dated February 19, 2025. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3029780
FEI number: 1000523896
Address: 705 S SPRINGBROOK RD. Bldg C, Newberg, OR, United States, 97132
Owner or operator: DCI International LLC (9099996)
Roles: Manufacturer, Repackager or relabeler
First device listed: December 5, 2007
Registered through: 2026
Brand names listed: Acteon® Newtron LED Piezoelectric Scaler, Assy, Nsk Display, S5 Dr, Curing Light, LED. G, Woodpecker, Curing Light, Mini LED, Acteon, DCI DENTAL UNIT & ACCESSORIES, DCI Edge, Dental Chair, Dental Delivery System Series 5 and 5 Plus and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Retractor, Dental	EIF	1	Manufacturer	accessdata.fda.gov
Activator, Ultraviolet, For Polymerization	EBZ	2	Repackager or relabeler	accessdata.fda.gov
Chair, Dental, With Operative Unit	KLC	1	Manufacturer	accessdata.fda.gov
Chair, Dental, Without Operative Unit	NRU	1	Manufacturer	accessdata.fda.gov
Controller, Foot, Handpiece And Cord	EBW	1	Repackager or relabeler	accessdata.fda.gov
Evacuator, Oral Cavity	EHZ	1	Manufacturer	accessdata.fda.gov
Handpiece, Air-Powered, Dental	EFB	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Repackager or relabeler	accessdata.fda.gov
Light, Operating, Dental	EAZ	1	Manufacturer	accessdata.fda.gov
Light-Induced Fluorescence Caries Detector	NBL	2	Repackager or relabeler	accessdata.fda.gov
Plaque Disclosing Kit	NYH	2	Repackager or relabeler	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Repackager or relabeler	accessdata.fda.gov
Unit, Operative Dental	EIA	1	Manufacturer	accessdata.fda.gov
Unit, Syringe, Air And/Or Water	ECB	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 19, 2025	K250473	Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus	EIA	Substantially Equivalent	Dci International, LLC	accessdata.fda.gov
June 2, 2023	K230888	Titanium Turbine	EFB	Substantially Equivalent	Nakanishi, Inc.	accessdata.fda.gov
June 21, 2022	K203791	Stainless Turbine	EFB	Substantially Equivalent	Nakanishi, Inc.	accessdata.fda.gov
October 27, 2020	K202960	General Cutting Contra Handpiece	EGS	Substantially Equivalent	Nakanishi, Inc.	accessdata.fda.gov
April 16, 2019	K182999	General Cutting Contra Handpiece	EGS	Substantially Equivalent	Nakanishi, Inc.	accessdata.fda.gov
August 31, 2017	K163402	NLZ Motor System	EBW	Substantially Equivalent	Nakanishi, Inc.	accessdata.fda.gov
June 1, 2016	K151987	DCI Edge Dental Chair with Operative Unit	KLC	Substantially Equivalent	Dci	accessdata.fda.gov
March 10, 2014	K132267	NEWTRON P5, NEWTRON P5 B.LED	ELC	Substantially Equivalent	Satelec - Acteon Group	accessdata.fda.gov
March 12, 2013	K121685	SOPROCARE	NBL	Substantially Equivalent	Sopro	accessdata.fda.gov
March 5, 2012	K113655	TI-MAX X TURBINE	EFB	Substantially Equivalent	Nakanishi, Inc.	accessdata.fda.gov
January 21, 2009	K081811	CARE3 PLUS	EFB	Substantially Equivalent	Nakanishi, Inc.	accessdata.fda.gov
March 19, 2008	K080025	LED.L, LED.M, LED.G, LED.B	EBZ	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov
September 19, 2007	K072181	MINI LED AUTOFOCUS	EBZ	Substantially Equivalent	Satelec	accessdata.fda.gov
August 21, 2006	K053555	ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L	ELC	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov
September 2, 2005	K052334	CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131	ELC	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
September 24, 1996	K962542	AIR MOTOR HANDPIECE TN-102	EFB	Substantially Equivalent	Nsk Nakanishi, Inc.	accessdata.fda.gov
September 12, 1996	K962540	E-TYPE CONTRA ANGLE NAC-E	EGS	Substantially Equivalent	Nsk Nakanishi, Inc.	accessdata.fda.gov
December 29, 1994	K944271	DENTAL OPERATIVE UNIT ACCESORIES	EIA	Substantially Equivalent	Dci Intl.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 27, 2011	59099	Not yet classified	Terminated	LuxStar Dental Light have the following Agency model or Catalog Model numbers as ML1000, OL1000, CL1000, WL1000, CB1000, TL1000, and UL1000. The product is labeled in part: " Marus Dental**Mfg By: Dental Equipment LLC.	Lens heat shield (birdcage) of the Luxstar Dental Light could fall and injure a patient.	accessdata.fda.gov
March 1, 2011	58122	Not yet classified	Terminated	Dental chairs distributed under several brand names such as DCI Equipment; Marus MaxStar; Marus NuStar; and Pelton & Crane. Part number for the bolt: 022R065 Product is labeled in part: DCI Equipment, Mfg By: Dental Equi	Link arm assembly that mounts the rear mounted accessories to the dental chair may potentially break and fall off the dental chair.	accessdata.fda.gov
March 23, 2010	55153	Not yet classified	Terminated	The magnetic headrest is designed to fit the following dental chairs (THE HEADREST IS THE RECALLED ITEM, NOT THE CHAIRS): The dental chairs are sold under the brand names Marus and DCI Equipment. The affected models are:	The magnetic headrest on certain dental chairs may affect the function/programming of some implantable pacemakers or defibrillators if the implanted device is programmed to respond to a magnet.	accessdata.fda.gov
May 1, 2007	38169	Not yet classified	Terminated	DCI Equipment Track Mount Light Assembly, 110v	Potential for light shield to melt due to light assemblies not properly rated to handle the VAC.	accessdata.fda.gov

Compare with other makers

Updated February 19, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.