Question 1

Who is the manufacturer of FRS LITE FLUORIDE RELEASING SEALANT?

Accepted Answer

Ormco Corp. filed the 510(k) submission for FRS LITE FLUORIDE RELEASING SEALANT (K890740).

Question 2

What is the FDA product code for FRS LITE FLUORIDE RELEASING SEALANT?

Accepted Answer

DYH. It is classified under 21 CFR 872.3750 as a Class 2 device in the Dental panel.

Question 3

When was FRS LITE FLUORIDE RELEASING SEALANT cleared by the FDA?

Accepted Answer

Apr 25, 1989 (decision: SESE).

Question 4

What is the regulatory pathway for FRS LITE FLUORIDE RELEASING SEALANT?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like FRS LITE FLUORIDE RELEASING SEALANT?

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	K890740
Device Name	FRS LITE FLUORIDE RELEASING SEALANT
Applicant	Ormco Corp.
Product Code	DYH · Dental
Decision Date	Apr 25, 1989
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3750
Device Class	Class 2

FRS LITE FLUORIDE RELEASING SEALANT

Device Facts

Regulatory Classification

Identification