BioMin Restore Plus

K200077 · Dr. Collins, Inc. · LBH · Nov 6, 2020 · Dental

Device Facts

• Record ID: K200077
• Device Name: BioMin Restore Plus
• Applicant: Dr. Collins, Inc.
• Product Code: LBH · Dental
• Decision Date: Nov 6, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Prescription fluoride dentifrice for use in the prevention and treatment of dental sensitivity.

Device Story

BioMin Restore Plus is a prescription fluoride dentifrice used for dental sensitivity. Active ingredient: BioMin F (calcium fluoro-phosphosilicate bioactive glass). Mechanism: upon exposure to aqueous environment (saliva), bioactive glass undergoes surface reaction to form fluorapatite, which physically occludes open dentin tubules. Applied to teeth via brush or similar applicator. Benefits: reduces dentinal hypersensitivity by mimicking natural tooth mineral structure. Used in clinical or home settings under prescription.

Clinical Evidence

Bench testing only. Dentine tubule occlusion effectiveness demonstrated to be equivalent to primary predicate. Relative Dentin Abrasivity (RDA) measured and found well below ADA safety limit (<250). Biocompatibility testing performed per ISO 10993; biological evaluation and toxicological risk assessment indicate no hazardous effects.

Technological Characteristics

Active ingredient: Calcium Fluoro-Phosphosilicate (bioactive glass). Form factor: Paste/gel. Principle: Physical occlusion of dentin tubules via fluorapatite layer formation. Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for patients requiring prevention and treatment of dental sensitivity.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Restore Toothpaste - Dr. Collins, Inc. (K181965)

Reference Devices

• Voco Paste - VOCO GMBH (K101104)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

# 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__________________________________________________________________________________________________________________________________________________________

{3}------------------------------------------------

# Section V

# 510(k) Summary

### Submitter:

Dr. Collins, Inc. 4330 Barranca Pkwy. Ste #100 Irvine, CA 92604 Contact Person: Jiahe Li Regulatory Affairs Manager [e-mail]

#### 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

{4}------------------------------------------------

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 (<250) established by American Dental Association (ADA).

#### Biocompatibility

Different biocompatibility tests in accordance with ISO10993 have been performed on the subject

{5}------------------------------------------------

device. Meanwhile, a biological evaluation and a toxicological risk assessment have also been conducted on the subject device. The results of these tests and studies indicate there is no evidence of any hazardous effects and the subject device is safe for its intended use.

### Device Comparison Table

| Element<br>of<br>Comparison | Subject<br>Device<br>BioMin®<br>Restore Plus | Primary<br>Predicate<br>Device<br>Restore<br>Toothpaste -<br>K181965 | Reference<br>Device<br>Voco Paste<br>K101104 | Substanti<br>ally<br>Equivalen<br>t | Remarks |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For dental<br>hypersensitivit<br>y relief | For dental<br>hypersensitivit<br>y relief | For dental<br>hypersensitivity<br>relief | Yes | -- |
| Indications for<br>Use | Prescription<br>fluoride<br>dentifrice for<br>use in the<br>prevention<br>and treatment<br>of dental<br>sensitivity. | A daily use<br>over-the-<br>counter<br>toothpaste<br>formulated to<br>provide rapid<br>and continual<br>tooth<br>sensitivity<br>relief. | Intended to be<br>used after<br>professional<br>tooth whitening,<br>professional<br>tooth cleaning<br>and for<br>prevention and<br>control of<br>hypersensitivitie<br>ട. | Yes | The only difference is<br>that the subject device<br>and reference device<br>are for prescription<br>use, while the primary<br>predicate device is for<br>OTC use. |
| Design | Paste/gel that<br>is applied to<br>the tooth<br>using an<br>applicator<br>brush or<br>similar<br>application. | Paste/gel that<br>is applied to<br>the tooth<br>using an<br>applicator<br>brush or<br>similar<br>application. | Paste/gel that is<br>applied to the<br>tooth using an<br>applicator brush<br>or similar<br>application. | Yes | -- |
| Composition of<br>Material | Apatite<br>forming<br>ingredient,<br>filler,<br>surfactant,<br>thickening<br>agent,<br>colorant, | Apatite<br>forming<br>ingredient,<br>filler,<br>surfactant,<br>thickening<br>agent,<br>colorant, | Apatite forming<br>ingredient &<br>hydroxyapatite,<br>filler, surfactant,<br>thickening<br>agent, colorant,<br>sweetener &<br>flavor enhancer. | Yes | The subject device<br>and the primary<br>predicate device have<br>exact the same<br>composing<br>ingredients, except for<br>the active ingredients,<br>which are also |

{6}------------------------------------------------

| Technological<br>Characteristics | Mode of<br>Action | sweetener &<br>flavor<br>enhancer.<br>Physical<br>occlusion of<br>dentin tubules | sweetener &<br>flavor<br>enhancer.<br>Physical<br>occlusion of<br>dentin tubules | Physical<br>occlusion of<br>dentin tubules | Yes | compositionally and<br>structurally very<br>similar. |
|----------------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Principle<br>of<br>Action | Occlude<br>dentin tubules<br>through<br>reaction with<br>saliva and<br>subsequent<br>formation of<br>apatite layer | Occlude<br>dentin tubules<br>through<br>reaction with<br>saliva and<br>subsequent<br>formation of<br>apatite layer | Occlude dentin<br>tubules through<br>reaction with<br>saliva and<br>subsequent<br>formation of<br>apatite layer<br>and direct<br>occlusion with<br>pre-formed<br>hydroxyapatite<br>particles | Yes | The technological<br>characteristics<br>between the subject<br>device and primary<br>predicate are the<br>same.<br>The reference device<br>differs slightly in that it<br>also contains some<br>pre-formed<br>hydroxyapatite<br>particles which can<br>occlude dentine tubule<br>directly. |
| | Biocompatibility | Yes | Yes | Yes | Yes | -- |

## Conclusion

Based on the comparison of the compositions and actions, as well as the testing data provided, BioMin® Restore Plus is considered to be substantially equivalent to the identified legally marketed predicate devices.