(297 days)
No
The device description and performance studies focus on the chemical and physical properties of the bioactive glass for tubule occlusion, with no mention of AI or ML.
Yes
The device is intended for the prevention and treatment of dental sensitivity, addressing a medical condition.
No
The device is a prescription fluoride dentifrice used for the prevention and treatment of dental sensitivity by physically occluding dentin tubules. Its purpose is therapeutic (treatment and prevention), not diagnostic.
No
The device description clearly indicates it is a dentifrice (toothpaste), which is a physical substance and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Prescription fluoride dentifrice for use in the prevention and treatment of dental sensitivity." This describes a product applied directly to the teeth for therapeutic purposes, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a toothpaste that works by physically occluding dentin tubules. This is a mechanical/chemical action within the mouth, not an in vitro test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a disease or condition
The device is a therapeutic product for dental use, not a diagnostic test.
N/A
Intended Use / Indications for Use
Prescription fluoride dentifrice for use in the prevention and treatment of dental sensitivity.
Product codes
LBH
Device Description
BioMin® Restore Plus is a daily-use, prescription fluoride dentifrice use in the prevention and treatment of dental sensitivity through physical occlusion of dentin tubules. The formulation incorporates BioMin™ F (Calcium Fluoro-Phosphosilicate, a particular form of bioactive glass) as its active ingredient. When exposed to an aqueous environment, BioMin™ F undergoes a rapid surface reaction to form Fluorapatite, which is chemically 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The formula of BioMin® Restore Plus was tested for its ability to reduce dentine hypersensitivity through physical occlusion of dentine tubule and its relative abrasion level of dentine and enamel.
The dentine tubule occlusion test result indicates that BioMin® Restore Plus 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 (
§ 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 6, 2020
Dr. Collins. Inc. Jiahe Li Regulatory Affair Associate 4330 Barranca Pkwy. Ste #100 Irvine, California 92604
Re: K200077
Trade/Device Name: BioMin Restore Plus Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: LBH Dated: July 19, 2020 Received: August 10, 2020
Dear Jiahe Li:
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 (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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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).
Sincerely,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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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Section IV
Indications for Use Statement
510(k) Number (if known): K200077
Device Name: _BioMin® Restore Plus
Indications for Use:
Prescription fluoride dentifrice for use in the prevention and treatment of dental sensitivity.
Prescription Use _____ X ____ OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
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Section V
510(k) Summary
Submitter:
Dr. Collins, Inc. 4330 Barranca Pkwy. Ste #100 Irvine, CA 92604 Contact Person: Jiahe Li Regulatory Affairs Manager Lijh0919@gmail.com
Date Summary Prepared:
November 4th, 2020
DEVICE NAME
| TRADE NAME: | BioMin® Restore Plus |
|---|---|
| COMMON NAME: | Dentifrice, Toothpaste |
| DEVICE CLASS: | Class II |
| CLASSIFICATION NAME: | Cavity Varnish |
| CLASSIFICATION PRODUCT CODE: | LBH |
| 510(K) NUMBER: | K200077 |
| REGULATION NUMBER: | 21 CFR 872.3260. |
PREDICATE DEVICE
Primary Predicate Decice: Restore Toothpaste - Dr. Collins, Inc. - K181965
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Reference Device: Voco Paste - VOCO GMBH - K101104
DESCRIPTION OF DEVICE
BioMin® Restore Plus is a daily-use, prescription fluoride dentifrice use in the prevention and treatment of dental sensitivity through physical occlusion of dentin tubules. The formulation incorporates BioMin™ F (Calcium Fluoro-Phosphosilicate, a particular form of bioactive glass) as its active ingredient. When exposed to an aqueous environment, BioMin™ F undergoes a rapid surface reaction to form Fluorapatite, which is chemically similar to natural tooth mineral, allowing it to physically occlude tubules.
INDICATIONS FOR USE
Prescription fluoride dentifrice for use in the prevention and treatment of dental sensitivity.
Technological Characteristics
The fundamental principle and mode of action of BioMin® Restore Plus is the same as the predicate devices. All three devices are designed to reduce dentinal hypersensitivity through the physical occlusion of open dentin tubules by the formation of an apatite layer.
BioMin™ F (Calcium Fluoro-Phosphosilicate, a particular form of bioactive glass) is the active ingredient in BioMin® Restore Plus's formulation. When exposed to an aqueous environment, BioMin™ F undergoes a rapid surface reaction to form Fluorapatite, which is chemically and structurally similar to natural tooth mineral, allowing it to physically occlude tubules.
Performance Tests
The formula of BioMin® Restore Plus was tested for its ability to reduce dentine hypersensitivity through physical occlusion of dentine tubule and its relative abrasion level of dentine and enamel.
The dentine tubule occlusion test result indicates that BioMin® Restore Plus 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 (