File, Margin Finishing, Operative

Which Manufacturers in China Make This?

One manufacturer in China holds an FDA registration for this device type, based in Shandong.

Xinhua Surgical Instrument Co., Ltd. Shandong

What Is FDA Product Code EKA?

File, Margin Finishing, Operative is FDA product code EKA, Class 1, 21 CFR 872.4565.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

File, Margin Finishing, Operative

Zoll-Dental

7 catalogue numbers from OPMT-27, listed by Zoll-Dental, under File, Margin Finishing, Operative. 1 manufacturer in China is registered for this product code.

File, Margin Finishing, Operative

HU-Friedy

#31/32 Rhein DE Amalgam File, #7 Color

File, Margin Finishing, Operative

Osung MND

A hand-held manual dental instrument that has various forms of ridged cutting surfaces at its working end(s) designed to scrape and smooth during a periodontal procedure. It is typically a…

File, Margin Finishing, Operative

Which Manufacturers in China Make This?

What Is FDA Product Code EKA?

How Does It Reach the US Market?

Zoll-Dental

HU-Friedy

Osung MND

Where China Actually Supplies