Question 1

Who is the manufacturer of PRISMA-FIL?

Accepted Answer

Dentsply Intl. filed the 510(k) submission for PRISMA-FIL (K801732).

Question 2

What is the FDA product code for PRISMA-FIL?

Accepted Answer

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

Question 3

When was PRISMA-FIL cleared by the FDA?

Accepted Answer

Aug 7, 1980 (decision: SESE).

Question 4

What is the regulatory pathway for PRISMA-FIL?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PRISMA-FIL?

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	K801732
Device Name	PRISMA-FIL
Applicant	Dentsply Intl.
Product Code	EBF · Dental
Decision Date	Aug 7, 1980
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3690
Device Class	Class 2

PRISMA-FIL

Device Facts

Regulatory Classification

Identification