Manufacturer registered with FDA
DCI International LLC
Newberg, OR, United States. Lists 14 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 14
- Brands and models
- 119
- 510(k) clearances
- 12025–2025
- Markets registered in
- 615 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name DCI International LLC as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | DCI International LLC | 1 clearances | 2025–2025 | Below |
| Taiwan | TFDA | Manufacturer | DCI INTERNATIONALDCI INTERNATIONAL LLC · DCI INTERNATIONAL, LLC · +2 | 7 | 2006–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | DCI International LLCDCI International, LLC | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | DCI InternationalDCI International LLC | 2 | 2019–2020 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | DCI International, LLC | 2 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | DCI International, LLC | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What DCI International LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Lister | NSK Air High Speed Coupler PTL-CL-LEDNSK Air High Speed M800LNSK Air High Speed M800L BundleNSK Air High Speed M900LNSK Air High Speed M900L BundleNSK Air High Speed Z800KLNSK Air High Speed Z800KL BundleNSK Air High Speed Z800LNSK Air High Speed Z800L BundleNSK Air High Speed Z890KL 10 moreNSK Air High Speed Z890LNSK Air High Speed Z900KLNSK Air High Speed Z900KL BundleNSK Air High Speed Z900LNSK Air High Speed Z900L BundleNSK Air High Speed Z990KLNSK Air High Speed Z990LNSK Air Low Speed iProphy Air BundleNSK iCare C2NSK iCare C3 | 2024 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | Assy, Nsk Display, S5 DrKit, Motor, Electric, NSK NLZ E, Mobile DR, LeftKit, Motor, Electric, NSK NLZ E, Mobile DR, RightKit, Motor, Electric, NSK NLZ E, Series 4, LeftKit, Motor, Electric, NSK NLZ E, Series 4, RightKit, Motor, Electric, NSK NLZ E, Series 5Kit, Motor, Electric, NSK NLZ E, Side Delivery, Series 5Kit, Motor, Electric, NSK NLZ E, Under Counter DRKit, NSK Retrofit, DR Mobile, Left HandedKit, NSK Retrofit, DR Mobile, Right Handed 23 moreKit, NSK Retrofit, DR Under CounterKit, NSK Retrofit, S4 DeliveryKit, NSK Retrofit, S5 DeliveryMotor, Electric, NSK NLZ ENSK Air Low Speed FX25 BundleNSK Air Low Speed FX57 BundleNSK Electric High Speed M95LNSK Electric High Speed M95L BundleNSK Electric High Speed Z95LNSK Electric High Speed Z95L BundleNSK Electric High Speed Z99LNSK Electric High Speed Z99L BundleNSK Electric Low Speed M25LNSK Electric Low Speed M25L BundleNSK Electric Low Speed Z25LNSK Electric Low Speed Z25L BundleSub-Assy, NSK w/DCI Display and Harness, Mobile, LeftSub-Assy, NSK w/DCI Display and Harness, Mobile, RightSub-Assy, NSK w/DCI Display and Harness, NSK AC AdapterSub-Assy, NSK w/DCI Display, DCI Display HarnessSub-Assy, NSK w/DCI Display, DCI Display Harness, Series 4 Right HandedSub-Assy, NSK w/DCI Display, NSK Display HarnessSub-Assy, NSK w/DCI Display, NSK Display Harness, DR5550 | 2024 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | DCI DENTAL UNIT & ACCESSORIESDCI EdgeDental Delivery System Series 5 and 5 PlusReliance | 2007 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Lister | Acteon® Newtron LED Piezoelectric ScalerKit, Ultrasonic Scaler, G139 w/Steri-Mate 360, CavitronUltrasonic Scaler, G139 w/Steri-Mate 360, CavitronUltrasonic Scaler, V6 LED, DTE, Woodpecker | 2024 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Lister | Curing Light, LED. G, WoodpeckerCuring Light, Mini LED, ActeonKit, Acteon Curing Lt, CartKit, Acteon Curing Lt, S4 Std, Light GrayKit, Acteon Curing Lt, S4 Std, WhiteKit, Acteon Curing Lt, S4, Light GrayKit, Acteon Curing Lt, S4, WhiteKit, Acteon Curing Lt, S5Kit, Acteon Curing Lt, S5 StdKit, DTE Curing Lt, Cart 6 moreKit, DTE Curing Lt, S4 Std, Light GrayKit, DTE Curing Lt, S4 Std, WhiteKit, DTE Curing Lt, S4, Light GrayKit, DTE Curing Lt, S4, WhiteKit, DTE Curing Lt, S5Kit, DTE Curing Lt, S5 Std | 2024 |
| Dental Chair with Operative UnitKLC · Class 1 | Dental chairs & operative units | Maker | DCI EdgeDental Delivery System Series 5 and 5 PlusReliance | 2017 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | Dental LED Light | 2015 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Lister | Assy, Nsk Display, S5 DrKit, Motor, Electric, NSK NLZ E, Mobile DR, LeftKit, Motor, Electric, NSK NLZ E, Mobile DR, RightKit, Motor, Electric, NSK NLZ E, Series 4, LeftKit, Motor, Electric, NSK NLZ E, Series 4, RightKit, Motor, Electric, NSK NLZ E, Series 5Kit, Motor, Electric, NSK NLZ E, Side Delivery, Series 5Kit, Motor, Electric, NSK NLZ E, Under Counter DRKit, NSK Retrofit, DR Mobile, Left HandedKit, NSK Retrofit, DR Mobile, Right Handed 11 moreKit, NSK Retrofit, DR Under CounterKit, NSK Retrofit, S4 DeliveryKit, NSK Retrofit, S5 DeliveryMotor, Electric, NSK NLZ ESub-Assy, NSK w/DCI Display and Harness, Mobile, LeftSub-Assy, NSK w/DCI Display and Harness, Mobile, RightSub-Assy, NSK w/DCI Display and Harness, NSK AC AdapterSub-Assy, NSK w/DCI Display, DCI Display HarnessSub-Assy, NSK w/DCI Display, DCI Display Harness, Series 4 Right HandedSub-Assy, NSK w/DCI Display, NSK Display HarnessSub-Assy, NSK w/DCI Display, NSK Display Harness, DR5550 | 2024 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Dental syringe and accessories | 2015 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | HVE and SE | 2017 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Mouth PropMouth Props, AdultMouth Props, ChildMouth Props, EdentulousMouth Props, Large AdultMouth Props, Small Pedo | 2023 |
| Light-Induced Fluorescence Caries DetectorNBL · Class 2 | Caries detection devices | Lister | Kit, Mini Dock U-USB2, w/o Camera, Acteon, Light GrayKit, Mini Dock U-USB2, w/o Camera, Acteon, Series 5, Light GrayKit, Mini Dock U-USB2, w/o Camera, Acteon, WhiteMini Dock U-USB2, Light Gray, Intra-Oral Camera, Acteon | 2024 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Dental Chair | 2015 |
| Plaque Disclosing KitNYH · Class 2 | — | Lister | Kit, Mini Dock U-USB2, w/o Camera, Acteon, Light GrayKit, Mini Dock U-USB2, w/o Camera, Acteon, Series 5, Light GrayKit, Mini Dock U-USB2, w/o Camera, Acteon, WhiteMini Dock U-USB2, Light Gray, Intra-Oral Camera, Acteon | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
DCI International LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Nakanishi, Inc. (7), Satelec - Acteon Group (2), Guilin Woodpecker Medical Instrument Co., Ltd. (2), Nsk Nakanishi, Inc. (2), Dci (1), Satelec (1), Dentsply Intl., Inc. (1), Dci Intl. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 2 Jun 2023 | K230888 | Titanium Turbine | Nakanishi, Inc. | EFB Dental Air-Powered Handpiece |
| 21 Jun 2022 | K203791 | Stainless Turbine | Nakanishi, Inc. | EFB Dental Air-Powered Handpiece |
| 27 Oct 2020 | K202960 | General Cutting Contra Handpiece | Nakanishi, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 16 Apr 2019 | K182999 | General Cutting Contra Handpiece | Nakanishi, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 31 Aug 2017 | K163402 | NLZ Motor System | Nakanishi, Inc. | EBW Handpiece and Cord Foot Controller |
| 1 Jun 2016 | K151987 | DCI Edge Dental Chair with Operative Unit | Dci | KLC Dental Chair with Operative Unit |
| 10 Mar 2014 | K132267 | NEWTRON P5, NEWTRON P5 B.LED | Satelec - Acteon Group | ELC Ultrasonic Scaler |
| 12 Mar 2013 | K121685 | SOPROCARE | Satelec - Acteon Group | NBL Light-Induced Fluorescence Caries Detector |
| 5 Mar 2012 | K113655 | TI-MAX X TURBINE | Nakanishi, Inc. | EFB Dental Air-Powered Handpiece |
| 21 Jan 2009 | K081811 | CARE3 PLUS | Nakanishi, Inc. | EFB Dental Air-Powered Handpiece |
| 19 Mar 2008 | K080025 | LED.L, LED.M, LED.G, LED.B | Guilin Woodpecker Medical Instrument Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 19 Sep 2007 | K072181 | MINI LED AUTOFOCUS | Satelec | EBZ Ultraviolet Activator for Polymerization |
| 21 Aug 2006 | K053555 | ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L | Guilin Woodpecker Medical Instrument Co., Ltd. | ELC Ultrasonic Scaler |
| 2 Sep 2005 | K052334 | CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 | Dentsply Intl., Inc. | ELC Ultrasonic Scaler |
| 24 Sep 1996 | K962542 | AIR MOTOR HANDPIECE TN-102 | Nsk Nakanishi, Inc. | EFB Dental Air-Powered Handpiece |
| 12 Sep 1996 | K962540 | E-TYPE CONTRA ANGLE NAC-E | Nsk Nakanishi, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 29 Dec 1994 | K944271 | DENTAL OPERATIVE UNIT ACCESORIES | Dci Intl. | EIA Operative Dental Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DCI International, LLCFDA reg. 3029780 | NEWBERG, OR, United States | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9099996). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.