Question 1

Who is the manufacturer of COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE?

Accepted Answer

Ultradent Products, Inc. filed the 510(k) submission for COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE (K921407).

Question 2

What is the FDA product code for COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE?

Accepted Answer

EBF. It is classified under 21 CFR 872.3690 as a Class 2 device in the Dental panel.

Question 3

When was COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE cleared by the FDA?

Accepted Answer

Sep 9, 1992 (decision: SESE).

Question 4

What is the regulatory pathway for COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE?

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	K921407
Device Name	COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE
Applicant	Ultradent Products, Inc.
Product Code	EBF · Dental
Decision Date	Sep 9, 1992
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3690
Device Class	Class 2

COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE

Device Facts

Regulatory Classification

Identification