FDA 510(k) K242913, Jasmate® Toothpaste, by Jasberry Healthcare Private Limited

FDA 510(k) K242913, Jasmate® Toothpaste, by Jasberry Healthcare Private Limited

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Device Classification Name: Varnish, Cavity
510(k) Number: K242913
Device Name: Jasmate® Toothpaste
Applicant: Jasberry Healthcare Private Limited
Regulation Number: 872.3260
Classification Product Code: LBH
Date Received: 09/24/2024
Decision Date: 11/22/2024
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
510k Review Panel: Dental

Total number of pages: 2,238
Fully redacted pages: 657
Content pages: 1,581

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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