Who is the manufacturer of Obturys?

Itena Clinical submitted the Abbreviated clearance for Obturys (K170207).

What is the FDA product code for Obturys?

KIF. It is classified under 21 CFR 872.3820 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Obturys?

510(k) clearance (submission type: Abbreviated).

Obturys

K170207 · Itena Clinical · KIF · Jul 31, 2017 · Dental

Device Facts

Record ID	K170207
Device Name	Obturys
Applicant	Itena Clinical
Product Code	KIF · Dental
Decision Date	Jul 31, 2017
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 872.3820
Device Class	Class 2

Regulatory Classification

Identification

A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.