Atlas FDA

Jasmate® Toothpaste

FDA 510(k) clearance K242913 · decided 2024-11-22

Clearance details

K-number
K242913
Device name
Jasmate® Toothpaste
Applicant
Jasberry Healthcare Private Limited
Decision
Substantially Equivalent
Date received
2024-09-24
Decision date
2024-11-22
Days to decision
59 days
Clearance type
Traditional
Product code
LBH
Device class
2
Regulation number
872.3260
Medical specialty
Dental
Advisory committee
Dental
Location
Kapurthala, IN
Third-party review
No
Expedited review
No

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Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) (K230333)Kettenbach GmbH & Co. KG2023-07-24
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Recalls involving this device

No recalls on record reference this clearance.