DCI International, LLC
Newberg, OR, US
DCI International, LLC appears in FDA device records in Newberg, OR. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to DCI International, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Dental Equipment LLCrecall
510(k) clearance history
FDA records hold 1 510(k) clearance for DCI International, LLC in 2025.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2025 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3029780 | 1000523896 | DCI International, LLC | 705 S SPRINGBROOK RD., NEWBERG, OR 97132 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EIFAccessories, Retractor, Dental
- EBZActivator, Ultraviolet, For Polymerization
- KLCChair, Dental, With Operative Unit
- NRUChair, Dental, Without Operative Unit
- EBWController, Foot, Handpiece And Cord
- EHZEvacuator, Oral Cavity
- EFBHandpiece, Air-Powered, Dental
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental
- EAZLight, Operating, Dental
- NBLLight-Induced Fluorescence Caries Detector
- NYHPlaque Disclosing Kit
- ELCScaler, Ultrasonic
- EIAUnit, Operative Dental
- ECBUnit, Syringe, Air And/Or Water
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2834-2011 | 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.***705 S. Springbrook Rd Building C Newberg, Oregon, 97132 USA***Dental Light***MN ML1000***". Product Usage: The intended use of the dental light is used for illuminating the oral cavity during the performance of dental procedures. | Lens heat shield (birdcage) of the Luxstar Dental Light could fall and injure a patient. | Terminated | ||
| Z-1958-2011 | 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 Equipment, LLC. DC1235, Marus Dental, Mfg By: Dental Equipment, LLC. DC1490, DC1690, and DC1700, and DC1702, Pelton & Crane, Spirit SP17. | Link arm assembly that mounts the rear mounted accessories to the dental chair may potentially break and fall off the dental chair. | Terminated | ||
| Z-2241-2010 | 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: Marus MaxStar-Agency Model # DC1490; Marus MaxStar-Agency Model # DC1690; Marus NuStar-Agency Model # DC1700; Marus NuStar-Agency Model # DC1702; Marus ProStar-Agency Model # DC1540; Marus ProStar-Agency Model # DC1535; DCI Equipment DC1235 Hydraulic-Agency Model # DC1235; and DCI Equipment DC1335 Electromechanical-Agency Model # DC1335. | 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. | Terminated | ||
| Z-1077-2007 | DCI Equipment Track Mount Light Assembly, 110v | Potential for light shield to melt due to light assemblies not properly rated to handle the VAC. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets DCI International, LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain