Question 1

Who is the manufacturer of COMPOSITE RESTORATIVE, PASTE/TYPE?

Accepted Answer

Scientific Pharmaceuticals, Inc. filed the 510(k) submission for COMPOSITE RESTORATIVE, PASTE/TYPE (K792140).

Question 2

What is the FDA product code for COMPOSITE RESTORATIVE, PASTE/TYPE?

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 RESTORATIVE, PASTE/TYPE cleared by the FDA?

Accepted Answer

Nov 30, 1979 (decision: SESE).

Question 4

What is the regulatory pathway for COMPOSITE RESTORATIVE, PASTE/TYPE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like COMPOSITE RESTORATIVE, PASTE/TYPE?

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	K792140
Device Name	COMPOSITE RESTORATIVE, PASTE/TYPE
Applicant	Scientific Pharmaceuticals, Inc.
Product Code	EBF · Dental
Decision Date	Nov 30, 1979
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3690
Device Class	Class 2

COMPOSITE RESTORATIVE, PASTE/TYPE

Device Facts

Regulatory Classification

Identification