Cleared Traditional

Jasmate? Toothpaste

K242913 · Jasberry Healthcare Private Limited · Dental

Nov 2024

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K242913 is an FDA 510(k) clearance for the Jasmate? Toothpaste, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Jasberry Healthcare Private Limited (Kapurthala, IN). The FDA issued a Cleared decision on November 22, 2024, 59 days after receiving the submission on September 24, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number	K242913 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2024
Decision Date	November 22, 2024
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF