APAPRO Desensitizer is a fluoride-free paste that is indicated to provide relief from tooth hypersensitivity resulting from cold, heat, acids, sweets, or contact, through its action of dentin tubule occlusion.

Device Description

APAPRO Desensitizer is a fluoride-free tooth desensitizing paste that utilizes hydroxyapatite, the main component of teeth, as its active ingredient to relieve tooth sensitivity by physically occluding exposed dentin tubules. The hydroxyapatite deposited into dentin tubules by APAPRO Desensitizer then acts as a template for the further deposition of large amounts of calcium and phosphate ions, promoting crystal integrity and growth.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental device, Apapro Desensitizer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with specific acceptance criteria related to a new device's performance metrics like sensitivity and specificity.

Therefore, the information requested about acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within the provided text.

The submission for Apapro Desensitizer (K220419) primarily relies on non-clinical tests comparing its mechanism of action and effectiveness in occluding dentin tubules to a predicate device, Oralief™ Therapy for Sensitive Teeth (K040858).

Here's what can be extracted based on your request, even if it highlights what's missing:

Table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated as quantifiable performance metrics (e.g., specific percentages for sensitivity, specificity, or accuracy) in the context of a clinical trial. The "acceptance criteria" here implicitly refer to demonstrating substantial equivalence to the predicate device based on technological characteristics, intended use, indications for use, and a similar mechanism of action.
Reported Device Performance: The primary reported "performance" is that "APAPRO Desensitizer was shown to be as effective as the NovaMin® found in the predicate device in occluding dentin tubules."

Trait	Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (APAPRO Desensitizer)
Indications for Use	Must be equivalent to the predicate device: Provides relief from tooth hypersensitivity resulting from cold, heat, acids, sweets, or contact, through its action of dentin tubule occlusion.	Provides relief from tooth hypersensitivity resulting from cold, heat, acids, sweets, or contact, through its action of dentin tubule occlusion. (Equivalent)
Intended Use	Must be equivalent to the predicate device: For dental hypersensitivity relief, prescribed and applied by dental physicians for use in the Adult Population.	For dental hypersensitivity relief, prescribed and applied by dental physicians for use in the Adult Population. (Equivalent)
Mechanism of Action	Must be equivalent or substantially similar to the predicate device: Formation of a hydroxyapatite layer to physically occlude dentin tubules.	Directly occludes dentin tubules by depositing a crystalline calcium phosphate layer (hydroxyapatite) on the tooth surface. (Equivalent in outcome, though different in active ingredient origin. Details in "Active Ingredient" and "Material Produced to Occlude Tubules").
Performance (Dentin Tubule Occlusion)	Must demonstrate comparable effectiveness in occluding dentin tubules to the predicate device.	SEM micrographs showed similar occlusion of dentin tubules as NovaMin-treated samples. "APAPRO Desensitizer was shown to be as effective as the NovaMin® found in the predicate device in occluding dentin tubules."
Biocompatibility	Must be biocompatible and non-antigenic, conforming to ISO 10993 standards.	Biocompatible, non-antigenic. Biocompatibility tests in accordance with ISO 10993 performed, and a biological risk assessment indicates no hazardous effects when used as directed in the Adult Population. (Equivalent)

Sample sizes used for the test set and the data provenance:
- Sample Size: Not specified. The "test set" in this context refers to dentin samples used for SEM imaging, not human subjects in a clinical trial.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study was a "non-clinical test" involving dentin samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was a non-clinical in vitro test using SEM micrographs, not a study requiring expert clinical interpretation for ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This was an in vitro comparison of SEM micrographs, not a human reader study.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is not an AI-based diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a material-based dental desensitizer, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical test, the "ground truth" for demonstrating dentin tubule occlusion was established through Scanning Electron Microscopy (SEM) micrographs to visually confirm the physical occlusion by the deposited hydroxyapatite layer. This is an objective laboratory measure.
The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this device is not an AI algorithm.
How the ground truth for the training set was established:
- Not applicable. There is no training set mentioned.

Summary

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February 16, 2022

Sangi Co, Ltd % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K220419

Trade/Device Name: Apapro Desensitizer Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity varnish Regulatory Class: Class II Product Code: LBH Dated: February 7, 2022 Received: February 14, 2022

Dear Dave Yungvirt:

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 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).

Sincerely,

Michael E. Adjodha, M.ChE. 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

510(k) Number (if known) K220419

Device Name APAPRO Desensitizer

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K220419

Image /page/3/Picture/2 description: The image is a logo for SANGI. The logo is a purple square with three horizontal white lines inside. Below the lines, the word "SANGI" is written in white, block letters.

SANGI CO., LTD., 3-11-6 TSUKIJI, CHUO-KU, TOKYO 104-8440, JAPAN TEL. +81 70-2680-2931 FAX. +81 3--3543-3651

Submitter Information:

Name:	Sangi Co., Ltd.
Address:	3-11-6 Tsukiji, Chuo-ku, Tokyo 104-8440 Japan
Phone:	+81 70-2680-2931
Facsimile:	+81 3-3543-3651
Contact Person:	Douglas Mercadante
Preparation Date:	12 May 2021

1. Device Nomenclature:

Trade Name:	APAPRO Desensitizer
Common Name:	Tooth Desensitizing Paste
Classification Name:	Cavity Varnish (21 CFR 872.326 Product code LBH)

1. Legally Marketed Predicate Device:

Device Name:	OraliefTM Therapy for Sensitive Teeth
510(k) Number:	K040858
Applicant:	NovaMin Technology, Inc.

1. Device Description:
  APAPRO Desensitizer is a fluoride-free tooth desensitizing paste that utilizes hydroxyapatite, the main component of teeth, as its active ingredient to relieve tooth sensitivity by physically occluding exposed dentin tubules. The hydroxyapatite deposited into dentin tubules by APAPRO Desensitizer then acts as a template for the further deposition of large amounts of calcium and phosphate ions, promoting crystal integrity and growth.

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Sangi Co., Ltd. Traditional 510(k) APAPRO Desensitizer

1. Indications for Use
  APAPRO Desensitizer is a fluoride-free paste that is indicated to provide relief from tooth hypersensitivity resulting from cold, heat, acids, sweets, or contact, through its action of dentin tubule occlusion.
1. Intended Use
  APAPRO Desensitizer is a fluoride-free paste that is indicated to provide relief from tooth hypersensitivity resulting from cold, heat, acids, sweets, or contact, through its action of dentin tubule occlusion. APAPRO Desensitizer is intended to be prescribed and applied by dental physicians for use in the Adult Population.
1. Technological Characteristics:
  Both APAPRO Desensitizer and the selected predicate device Oralief™ Therapy for Sensitive Teeth are intended to be used to treat the same disorder, namely for tooth hypersensitivity, by the same mode of action, which is the deposition of a calcium hydroxyapatite layer onto the tooth surface resulting in the physical occlusion of dentin tubules. The two devices differ in that Oralief The Therapy for Sensitive Teeth uses calcium sodium phosphosilicate (NovaMin®) as its active ingredient, which when introduced to the physiological fluid of the mouth, reacts to form a hydroxycarbonate apatite layer on the teeth, whereas APAPRO Desensitizer introduces synthetic hydroxyapatite directly onto the tooth surface. APAPRO Desensitizer is to be prescribed and applied by a dental professional. Oralief Therapy for Sensitive Teeth is also a home-use device to be prescribed by dental professionals.
1. Safety and Performance Data:
  The ability of APAPRO Desensitizer to provide relief from tooth hypersensitivity was shown by non-clinical tests demonstrating that it physically occludes exposed dentin tubules. The SEM micrographs of dentin samples with tubules occluded by APAPRO Desensitizer were compared to SEM Micrographs of NovaMintreated dentin samples. The SEM Micrographs of APAPRO Desensitizer and NovaMin-treated samples showed similar occlusion of the dentin tubules, which was achieved in both cases by the deposition of a hydroxyapatite layer onto the surface of the tooth. Thus APAPRO Desensitizer was shown to be as effective as the NovaMin® found in the predicate device in occluding dentin tubules.

Trait	APAPRO DesensitizerNew Device	Oralief™ Therapy forSensitive TeethPredicate Device	EquivalenceDetermination
510(k) Number	TBD	K040858	N/A
ClassificationNumber	872.3260	872.3260	Equivalent
Product Code	LBH	LBH	Equivalent
ProductClassification	Class II	Class II	Equivalent

1. Device Comparison Table:

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Sangi Co., Ltd. Traditional 510(k) APAPRO Desensitizer

Prescription/Over-the-counter use	Prescription	Prescription	Equivalent
Intended Use	For dental hypersensitivity relief	For dental hypersensitivity relief	Equivalent
Indications forUse	Provides rapid and continual relieffrom tooth hypersensitivity due tocold, heat, acids, sweets, orcontact through its action of theocclusion of dentin tubules.	Provides rapid and continualrelief from tooth hypersensitivitydue to cold, heat, acids, sweets,or contact through its action ofthe occlusion of dentin tubules.	Equivalent
ActiveIngredient	20% w/w Calcium Phosphate(Hydroxyapatite)	7.5% w/w Calcium SodiumPhosphosilicate (NovaMin®)	Equivalent*
Device Action	APAPRO Desensitizer directlyoccludes dentin tubules bydepositing a crystalline calciumphosphate layer on the toothsurface (i.e. hydroxyapatite).	The NovaMin® particles reactwith the user's saliva to releasecalcium and phosphate ions,which precipitate onto the toothsurface as a crystalline calciumphosphate layer (i.e.hydroxycarbonate apatite).	Equivalent
MaterialProduced toOccludeTubules	Hydroxyapatite	Hydroxycarbonate Apatite	Equivalent*
Performance	The hydroxyapatite layer occludesexposed dentin tubules, whichresults in desensitization.	The hydroxycarbonate apatitelayer occludes exposed dentintubules, which results indesensitization.	Equivalent
Biocompatibility	Biocompatible, non-antigenic	Biocompatible, non-antigenic	Equivalent
Sterility	Supplied non-sterile	Supplied non-sterile	Equivalent

*Details are provided in Section 12

1. Biocompatibility
  Biocompatibility tests in accordance with ISO 10993 have been performed on APAPRO Desensitizer. A biological risk assessment, captured in the enclosed Biological Evaluation Report, has also been performed and included in this Traditional 510(k) application package. The biocompatibility assessment indicated that APAPRO Desensitizer has no hazardous effects to the consumer when used as directed in the Adult Population.
1. Conclusions:

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Sangi Co., Ltd. Traditional 510(k) APAPRO Desensitizer

APAPRO Desensitizer is considered to be substantially equivalent to the legally marketed predicate device, Oralief™ Therapy for Sensitive Teeth. Both products are indicated for the relief of tooth hypersensitivity through the occlusion of dentin tubules. Both products achieve this by producing a calcium hydroxyapatite layer on the tooth surface. Additionally, both products have been shown to have comparable effectiveness with regards to tubule occlusion. No additional safety concerns have been observed when comparing APAPRO Desensitizer to Oralief™ Therapy for Sensitive Teeth.

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.