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.

AI/ML Overview

The provided text is a 510(k) summary for the device "BioMin® Restore Plus," a fluoride dentifrice intended to prevent and treat dental sensitivity by occluding dentin tubules. Here's a breakdown of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for "BioMin® Restore Plus" are primarily based on its ability to perform comparably to its predicate devices in terms of dentin tubule occlusion and safety (abrasivity).

Acceptance Criteria Item	Reported Device Performance
Dentine Tubule Occlusion Effectiveness	"BioMin® Restore Plus is as effective as the primary predicate device at dentine tubule occlusion."
Relative Dentin Abrasivity (RDA)	"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)." The specific RDA value is not provided but stated to be <250.
Biocompatibility	"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." (This implies meeting established biocompatibility standards like ISO10993).
Technological Characteristics	The fundamental principle and mode of action (physical occlusion of dentin tubules via apatite layer formation) of BioMin® Restore Plus is the same as the predicate devices. The active ingredients are compositionally and structurally very similar to the primary predicate device. The reference device differs slightly due to containing pre-formed hydroxyapatite particles for direct tubule occlusion, but the overall principle is considered substantially equivalent.
Intended Use	"For dental hypersensitivity relief" (matches predicate devices).
Indications for Use	"Prescription fluoride dentifrice for use in the prevention and treatment of dental sensitivity." (Equivalent to predicate devices although the primary predicate is OTC and the subject device is prescription, this difference is noted but deemed not to affect substantial equivalence in this context).
Design	"Paste/gel that is applied to the tooth using an applicator brush or similar application." (Matches predicate devices).
Composition of Material	Composing ingredients (filler, surfactant, thickening agent, colorant, sweetener & flavor enhancer) are exact same as primary predicate, differing only in active ingredients which are still compositionally and structurally very similar apatite-forming ingredients. The reference device also contains hydroxyapatite.
Principle of Action	"Occlude dentin tubules through reaction with saliva and subsequent formation of apatite layer." (Matches primary predicate. Reference device also has this principle but additionally features direct occlusion with pre-formed hydroxyapatite particles, a slight difference but still considered substantially equivalent).

2. Sample Size Used for the Test Set and Data Provenance

The document states: "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."

Sample Size for Test Set: The document does not specify the sample size used for the dentine tubule occlusion test or the Relative Dentin Abrasivity (RDA) test.
Data Provenance: The document does not provide details on the country of origin of the data or whether the studies were retrospective or prospective. It only mentions that "Biocompatibility" tests were performed "in accordance with ISO10993."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide any information about the number of experts, their qualifications, or their involvement in establishing ground truth for the performance tests. The performance tests appear to be laboratory-based evaluations rather than expert consensus-driven clinical assessments.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method as the reported performance tests are laboratory-based and yield measurable outcomes (e.g., occlusion effectiveness, RDA values) rather than subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. The device is a dentifrice, not an imaging or diagnostic AI device that typically involves human readers.

6. Standalone Performance Study

The reported "Performance Tests" describe the standalone performance of the BioMin® Restore Plus formula in terms of its ability to occlude dentin tubules and its abrasivity. These tests evaluate the algorithm/device's effect independently.

"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)."

7. Type of Ground Truth Used

The ground truth for the performance tests appears to be established through scientific measurements and widely accepted dental standards:

Dentin Tubule Occlusion: The "ground truth" would likely be based on objective in-vitro or in-situ measurements (e.g., using microscopy) of the extent of tubule occlusion, compared against the predicate device's performance.
Relative Dentin Abrasivity (RDA): The "ground truth" is defined by a quantitative measurement of abrasivity, compared against an established safety limit (<250) set by the American Dental Association (ADA).
Biocompatibility: The "ground truth" for safety is established by adherence to recognized international standards such as ISO10993.

8. Sample Size for the Training Set

The document does not mention a "training set" as this is not a machine learning or AI-driven device in the context of typical AI medical device submissions. The "formula" and "active ingredient" are tested for their inherent properties.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set, the question of how its ground truth was established is not applicable to this submission.

Summary

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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

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

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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

ElementofComparison	SubjectDeviceBioMin®Restore Plus	PrimaryPredicateDeviceRestoreToothpaste -K181965	ReferenceDeviceVoco PasteK101104	SubstantiallyEquivalent	Remarks
Intended Use	For dentalhypersensitivity relief	For dentalhypersensitivity relief	For dentalhypersensitivityrelief	Yes	--
Indications forUse	Prescriptionfluoridedentifrice foruse in thepreventionand treatmentof dentalsensitivity.	A daily useover-the-countertoothpasteformulated toprovide rapidand continualtoothsensitivityrelief.	Intended to beused afterprofessionaltooth whitening,professionaltooth cleaningand forprevention andcontrol ofhypersensitivitieട.	Yes	The only difference isthat the subject deviceand reference deviceare for prescriptionuse, while the primarypredicate device is forOTC use.
Design	Paste/gel thatis applied tothe toothusing anapplicatorbrush orsimilarapplication.	Paste/gel thatis applied tothe toothusing anapplicatorbrush orsimilarapplication.	Paste/gel that isapplied to thetooth using anapplicator brushor similarapplication.	Yes	--
Composition ofMaterial	Apatiteformingingredient,filler,surfactant,thickeningagent,colorant,	Apatiteformingingredient,filler,surfactant,thickeningagent,colorant,	Apatite formingingredient &hydroxyapatite,filler, surfactant,thickeningagent, colorant,sweetener &flavor enhancer.	Yes	The subject deviceand the primarypredicate device haveexact the samecomposingingredients, except forthe active ingredients,which are also

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TechnologicalCharacteristics	Mode ofAction	sweetener &flavorenhancer.Physicalocclusion ofdentin tubules	sweetener &flavorenhancer.Physicalocclusion ofdentin tubules	Physicalocclusion ofdentin tubules	Yes	compositionally andstructurally verysimilar.
	PrincipleofAction	Occludedentin tubulesthroughreaction withsaliva andsubsequentformation ofapatite layer	Occludedentin tubulesthroughreaction withsaliva andsubsequentformation ofapatite layer	Occlude dentintubules throughreaction withsaliva andsubsequentformation ofapatite layerand directocclusion withpre-formedhydroxyapatiteparticles	Yes	The technologicalcharacteristicsbetween the subjectdevice and primarypredicate are thesame.The reference devicediffers slightly in that italso contains somepre-formedhydroxyapatiteparticles which canocclude dentine tubuledirectly.
	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.

Regulation Number and Section

§ 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.