Question 1

Who is the manufacturer of ROOT CANAL FILLING CEMENT?

Accepted Answer

Confi-Dental Products Co. filed the 510(k) submission for ROOT CANAL FILLING CEMENT (K914325).

Question 2

What is the FDA product code for ROOT CANAL FILLING CEMENT?

Accepted Answer

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

Question 3

When was ROOT CANAL FILLING CEMENT cleared by the FDA?

Accepted Answer

Mar 9, 1992 (decision: SESE).

Question 4

What is the regulatory pathway for ROOT CANAL FILLING CEMENT?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ROOT CANAL FILLING CEMENT?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K914325
Device Name	ROOT CANAL FILLING CEMENT
Applicant	Confi-Dental Products Co.
Product Code	KIF · Dental
Decision Date	Mar 9, 1992
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3820
Device Class	Class 2

ROOT CANAL FILLING CEMENT

Device Facts

Regulatory Classification

Identification