Question 1

Who is the manufacturer of POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION)?

Accepted Answer

Healex Products, Inc. filed the 510(k) submission for POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION) (K954976).

Question 2

What is the FDA product code for POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION)?

Accepted Answer

EBG. It is classified under 21 CFR 872.3770 as a Class 2 device in the Dental panel.

Question 3

When was POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION) cleared by the FDA?

Accepted Answer

Apr 25, 1996 (decision: SESE).

Question 4

What is the regulatory pathway for POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION)?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION)?

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	K954976
Device Name	POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION)
Applicant	Healex Products, Inc.
Product Code	EBG · Dental
Decision Date	Apr 25, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3770
Device Class	Class 2

POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION)

Device Facts

Regulatory Classification

Identification