Question 1

Who is the manufacturer of DENTURE CLEANSERS?

Accepted Answer

Dental Research Laboratories filed the 510(k) submission for DENTURE CLEANSERS (K872521).

Question 2

What is the FDA product code for DENTURE CLEANSERS?

Accepted Answer

JER. It is classified under 21 CFR 872.3530 as a Class 1 device in the Dental panel.

Question 3

When was DENTURE CLEANSERS cleared by the FDA?

Accepted Answer

Aug 11, 1987 (decision: SESE).

Question 4

What is the regulatory pathway for DENTURE CLEANSERS?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like DENTURE CLEANSERS?

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	K872521
Device Name	DENTURE CLEANSERS
Applicant	Dental Research Laboratories
Product Code	JER · Dental
Decision Date	Aug 11, 1987
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3530
Device Class	Class 1

DENTURE CLEANSERS

Device Facts

Regulatory Classification

Identification