(59 days)
BioMin® Restore Plus (K200077)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of the toothpaste and its active ingredients, with no mention of AI or ML technologies.
Yes
The device is a toothpaste intended for the prevention and treatment of dental sensitivity, which is a therapeutic purpose. It works by physically occluding dentin tubules and using active ingredients like sodium fluoride to make teeth more resistant to demineralization.
No
Explanation: This device, Jasmate® Toothpaste, is described as a fluoride dentifrice used for the prevention and treatment of dental sensitivity. It functions by physically occluding dentin tubules and does not mention any role in diagnosing conditions or diseases.
No
The device is a toothpaste, which is a physical substance containing active ingredients (sodium fluoride and hydroxyapatite) intended for direct application to teeth. It is not software.
Based on the provided information, Jasmate® Toothpaste is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the prevention and treatment of dental sensitivity by physically occluding dentin tubules. This is a therapeutic and preventative action performed directly on the patient's teeth, not a test performed on a sample taken from the body to provide diagnostic information.
- Device Description: The description details the chemical composition and mechanism of action (physical occlusion of tubules and remineralization) which are consistent with a therapeutic or preventative product applied to the body.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample (like saliva, tissue, etc.) or providing diagnostic information about a patient's condition. The performance studies focus on the physical and chemical effects of the toothpaste on teeth and dentin, not on diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. Jasmate® Toothpaste does not fit this description.
N/A
Intended Use / Indications for Use
Jasmate® Toothpaste is prescription fluoride dentifrice for use in the prevention and treatment of dental sensitivity.
Product codes (comma separated list FDA assigned to the subject device)
LBH
Device Description
Jasmate® toothpaste is a fluoride-containing dentifrice designed for use in the prevention and treatment of dental sensitivity.
Jasmate® toothpaste is a dentist and dental professional prescribed, daily-use, fluoride dentifrice to be used in the prevention and treatment of dental sensitivity through the physical occlusion of dentin tubules.
Sodium fluoride is absorbed by the surface of hydroxyapatite crystals on the teeth, which are needed for mineralization. This makes the teeth more resistant to demineralization by changing the apatite crystal solubility. Sodium fluoride inhibits the demineralization of teeth in a pH-related manner. Sodium fluoride and hydroxyapatite are active ingredients. When exposed environment, it undergoes a rapid surface reaction to form fluorapatite, which is chemically and structurally similar to natural tooth mineral, allowing it to physically occlude tubules.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth (dental)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist and dental professional prescribed, daily-use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical study: Compared the performance and physical properties of Jasmate® Toothpaste with the predicate device BioMinF® Toothpaste to establish equivalence.
Key results:
- Physical Properties (Density, pH, Viscosity, Spreadability, Foaming Power): Jasmate® demonstrated statistically equivalent values compared to BioMinF®, and no significant difference was observed.
- Dentin Sensitivity Performance (Relative Dentin Abrasion (RDA), Enamel Fluoride Uptake (EFU), Enamel Solubility Reduction (ESR)): Both toothpastes showed equivalent abrasiveness and significant improvements in EFU and ESR, confirming comparable fluoride delivery and remineralization capabilities.
- Tubule Occlusion: Scanning Electron Microscopy (SEM) analysis revealed significant increases in dentin tubule occlusion for both products. Jasmate® achieved 80% occlusion in Grade A compared to BioMinF®’s 50%, though grading scales differed between studies.
- Active Ingredients: Jasmate® utilizes Sodium Fluoride (500 ppm), while BioMinF® contains Fluoro Calcium Phospho Silicate. Both active ingredients effectively address dentin hypersensitivity, with comparable mechanisms of action.
Performance Tests:
- Dentine tubule occlusion test: Jasmate® toothpaste is as effective as the primary predicate device at dentine tubule occlusion.
- Relative Dentin Abrasivity (RDA) value: Similar to the primary predicate and well under the limit considered safe for daily use (
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
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November 22, 2024
Jasberry Healthcare Private Limited Balwant Rai CEO. Chief Science Officer 162 Model Town Kapurthala, Punjab 144401 India
Re: K242913
Trade/Device Name: Jasmate® Toothpaste Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: LBH Dated: September 24, 2024 Received: September 24, 2024
Dear Balwant Rai:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Jasmate® Toothpaste
Indications for Use (Describe)
Jasmate® Toothpaste is prescription fluoride dentifrice for use in the prevention and treatment of dental sensitivity.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for JASBERRY HEALTHCARE PVT. LTD. The word "JAS" is in blue, and the word "BERRY" is in purple. There is a green leaf on top of the "B" in "BERRY". The words "HEALTHCARE PVT. LTD." are in smaller, purple font below the word "BERRY".
K242913
Pre-market Notification 510(k) Summary
General Company Information
| 510(k) Submitter | : Jasberry Healthcare Private Limited |
|---|---|
| Company Address | : 162 Model town, Kapurthala, Punjab, India. |
| Contact Person Name | : Dr. Balwant Rai |
| Title | : CEO, Chief Science Officer |
| Contact Emails | : raibalwant29@gmail.com, rai@jasberryhealthcare.com |
| Contact Number | : +919888081234 |
| Dated | : 17-09-2024 |
Throughout the submission, there is mention of Jasmate® toothpaste, a dental sensitivity reduction device, representing the range of products covered under this 510(k) submission.
| Device Information | |
|---|---|
| Proprietary Name | : Jasmate® toothpaste |
| Common or Usual Name | : Cavity Varnish |
| Regulation Number | : 21 CFR 872.3260 |
| Regulation Name | : Cavity Varnish |
| Regulatory Class | : Class 2 |
| Review Panel | : Dental |
Variants/Types: Jasmate® toothpaste is provided in the form of a fluoride-containing dentifrice.
Further Description of Jasmate® toothpaste
Jasmate® toothpaste is a fluoride-containing dentifrice designed for use in the prevention and treatment of dental sensitivity.
Indications for Use:
Jasmate® toothpaste is prescription fluoride dentifrice for use in the prevention and treatment of dental sensitivity.
Identification of the Predicate Device
| S.No. | Subject Device | Predicate Device |
|---|---|---|
| 1 | Jasmate® | BioMin® Restore Plus (K200077) |
Description of the Device Device Description:
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Image /page/5/Picture/0 description: The image shows the logo for JASBERRY HEALTHCARE PVT. LTD. The word "JAS" is in blue, and the word "BERRY" is in purple. There is a green leaf on top of the "B" in "BERRY". The words "HEALTHCARE PVT. LTD." are in smaller font below the word "BERRY".
Jasmate® toothpaste is a dentist and dental professional prescribed, daily-use, fluoride dentifrice to be used in the prevention and treatment of dental sensitivity through the physical occlusion of dentin tubules.
Sodium fluoride is absorbed by the surface of hydroxyapatite crystals on the teeth, which are needed for mineralization. This makes the teeth more resistant to demineralization by changing the apatite crystal solubility. Sodium fluoride inhibits the demineralization of teeth in a pH-related manner. Sodium fluoride and hydroxyapatite are active ingredients. When exposed environment, it undergoes a rapid surface reaction to form fluorapatite, which is chemically and structurally similar to natural tooth mineral, allowing it to physically occlude tubules.
Summary of Technological Characteristics
The fundamental principle and mode of action of Jasmate® toothpaste is the same as the predicate device. This device is designed to reduce dentinal hypersensitivity through the physical occlusion of open dentin tubules by the formation of an apatite layer. Potassium nitrate decreases the fluid flow through the tubules by clogging them, thereby decreasing the level of activity of dental sensory nerves and prevents or reduces the sensation signals from reaching the brain. Sodium fluoride is absorbed by the surface of hydroxyapatite crystals on the teeth, which are needed for mineralization. This makes the teeth more resistant to demineralization by changing the apatite crystal solubility. Sodium fluoride inhibits the demineralization of teeth in a pH-related manner.
Comparison of Technology Characteristics
The non-clinical study compared the performance and physical properties of Jasmate® Toothpaste with the predicate device BioMinF® Toothpaste to establish equivalence. The study evaluated key characteristics, including physical properties, dentin sensitivity performance, and tubule occlusion efficacy, as summarized below:
Physical Properties
- Density, pH, Viscosity, Spreadability: Jasmate® demonstrated statistically equivalent . values compared to BioMinF®, confirming similar physical behavior, as reported in the In-vitro Study Report.
- Foaming Power: No significant difference was observed, indicating comparable user . experience.
Dentin Sensitivity Performance
- Relative Dentin Abrasion (RDA): Both toothpastes showed equivalent abrasiveness, . ensuring safe and effective cleaning without excessive wear.
- Enamel Fluoride Uptake (EFU): Significant improvements were observed post-treatment . for both formulations, confirming comparable fluoride delivery and remineralization capabilities.
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Image /page/6/Picture/0 description: The image shows the logo for JASBERRY HEALTHCARE PVT. LTD. The word "JAS" is in blue, and the rest of the word "BERRY" is in purple. There is a green leaf on the top left of the "B" in "BERRY". The words "HEALTHCARE PVT. LTD." are in a smaller font below the word "JASBERRY".
- Enamel Solubility Reduction (ESR): Both products significantly reduced enamel . solubility post-treatment, demonstrating similar efficacy in enhancing remineralization and protecting enamel.
Tubule Occlusion
- Scanning Electron Microscopy (SEM): Post-treatment analysis revealed significant . increases in dentin tubule occlusion for both products. Jasmate® achieved 80% occlusion in Grade A compared to BioMinF®'s 50%, suggesting superior occlusion capability, though grading scales differed between studies.
Active Ingredients
- Jasmate® utilizes Sodium Fluoride (500 ppm), while BioMinF® contains Fluoro . Calcium Phospho Silicate. Both active ingredients effectively address dentin hypersensitivity, with comparable mechanisms of action in tubule occlusion and nerve desensitization.
Overall, the non-clinical study establishes the equivalence of Jasmate® Toothpaste to BioMinF® Toothpaste in terms of physical properties, therapeutic performance, and safety.
Performance Tests
The formula of Jasmate® toothpaste was tested for its ability to reduce dentine hypersensitivity through physical occlusion of dentine tubules and its relative abrasion level of dentine and enamel. The dentine tubule occlusion test result indicates that Jasmate® toothpaste is as effective as the primary predicate device at dentine tubule occlusion. Meanwhile, the Relative Dentin Abrasivity (RDA) value is similar to the primary predicate and is well under the limit considered safe for daily use (