[Good News of DPR] Congratulations to our dental alloy powder products for obtaining FDA listing approval!

Congratulations on the FDA listing approval of three dental alloy powders from DPR New Materials Technology CO., LTD.

DPR-M01, DPR-M02 and DPR-M03 have successfully obtained the 510(k) clearance of FDA!


FDA Registration Details of DPR

I. Introduction of FDA

The U.S. Food and Drug Administration (U.S. Food and Drug Administration, abbreviated as FDA) is a federal government agency under the authority of the U.S. Department of Health and Human Services, whose primary function is to supervise and regulate the domestic production and importation of food, dietary supplements, drugs, vaccines, bio-pharmaceutical preparations, blood preparations, medical devices, radiological devices, veterinary drugs, and cosmetics. It is also responsible for the enforcement of Section 361 of the Public Health Service Act, including the inspection of public health conditions and interstate travel and transportation, and the control of diseases that may be present in many products. The FDA has the power to inspect manufacturers and to prosecute offenders.

510(K) refers to an application to the FDA for permission to enter the US market for a medical device, i.e. a Pre-market Notification, named because it corresponds to Chapter 510 of the US Food, Drug and Cosmetic Act (FD&C Act). It is intended to demonstrate that the product is Substantially Equivalent to a product already on the market. Substantial Equivalence means: proof that the product for which marketing is sought is substantially equivalent in terms of safety and efficacy compared to a product already legally marketed in the United States.

II. Approved Product Information

1. Product name: Cobalt Chromium Alloy Powder

Product type: DPR-M01, DPR-M03

2. Product name: Titanium Alloy Powder

Product Model:DPR-M02

III. Intended Use of Product 


The DPR-M01 supports the dual use of one powder. DPR-M01 and DPR-M02 is an additive manufacturing laser-selective melting method for dental restorations, metal crowns and bridges for porcelain metal restorations, metal full crowns, bridges, inlays and cores for metal restorations, removable partial denture stands and retainers, and full denture stands.

DPR-M03 Dental restorations by additive manufacturing laser-selective melting for removable partial denture stands and retainers for metal restorations, full denture stands, implant upper restorations, orthodontic stands.

With the FDA approval, Beijing DPR will be able to provide better quality and more professional products for overseas exporters and provide more attentive service to foreign customers.

DPR devotes to assisting the digital dentistry.