Point, Silver, Endodontic

Which Manufacturers in China Make This?

The one Chinese manufacturer registered for this device type is based in Jiangsu.

Wuxi Lyusmile IMP AND EXP Co., Ltd. Jiangsu

What Is FDA Product Code EKL?

Point, Silver, Endodontic is FDA product code EKL, Class 1, 21 CFR 872.3840.

What Does It Take to Sell It in the United States?

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.

Point, Silver, Endodontic

Edta Solution, 17%

LIQUID SOLUTION 120 mL bottle

Point, Silver, Endodontic

Sonendo 17% Edta

Sonendo EDTA is a 17% EDTA chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin.

Point, Silver, Endodontic

File-Rite™

KIT: 4 x 5 gm syringes File-Rite + 50 applicator tips Canal Lubricant and Chelating Agent

Point, Silver, Endodontic

Roydent

C.L. Canal Lubricant (20 Count

Point, Silver, Endodontic

Which Manufacturers in China Make This?

What Is FDA Product Code EKL?

What Does It Take to Sell It in the United States?

Edta Solution, 17%

Sonendo 17% Edta

File-Rite™

Roydent

Where China Actually Supplies