510(k) K242913

Jasmate® Toothpaste by Jasberry Healthcare Private Limited — Product Code LBH

K242913 is an FDA 510(k) premarket notification submitted by Jasberry Healthcare Private Limited for the device "Jasmate® Toothpaste". The FDA issued a decision of Substantially Equivalent on November 22, 2024. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2024
Date Received
September 24, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Varnish, Cavity
Device Class
Class II
Regulation Number
872.3260
Review Panel
DE
Submission Type