The subject device consists of POWDER which contains Calcium Phosphate as a major component and LIQUID which mainly contains water. POWDER and LIQUID are mixed to obtain paste. The paste applied to the affected area transforms to a hardened material of hydroxyapatite and it suppresses hypersensitivity by sealing the dentin tubules and microcracks in the enamel.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called TEETHMATE DESENSITIZER. This submission is for a partial change to a predicate device, specifically altering the wording of one "Indications for use" statement.

The core of the submission argues for substantial equivalence to the predicate device, K122421, rather than presenting a new study with explicit acceptance criteria and device performance metrics in the format requested. The document states that the effectiveness and performance are "substantially equivalent" because the chemical ingredients, hypersensitivity-suppressing mechanism, and technological characteristics are the same as the predicate device.

Therefore, many of the requested fields cannot be directly extracted from the provided text as it focuses on demonstrating equivalence rather than reporting on a new performance study with specific acceptance criteria and detailed study methodology for the modified device.

However, based on the information provided, here's what can be inferred and explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to the predicate device (K122421) under the modified indication for use. This means demonstrating that the device is as safe and effective as a legally marketed device. The specific criteria for demonstrating this substantial equivalence are outlined by the FDA's 510(k) regulations, which in this case, focus on:
- Same intended uses (with the minor modification in wording)
- Same chemical ingredients/safety
- Same technological characteristics/effectiveness and performance
- Same biocompatibility
Reported Device Performance: The document doesn't provide quantitative performance metrics for "TEETHMATE DESENSITIZER" against a new set of acceptance criteria. Instead, it asserts its performance is equivalent to the predicate.
- It does mention two specific investigations regarding the effect of the modification:
  - "it was confirmed that there was no difference in sealing performance between before and after bleaching teeth when investigated the ability of the subject device to seal microcracks in the enamel before and after bleaching."
  - "it was confirmed that the subject device used before bleaching did not affect the bleaching performance when investigated the effect of the subject device on the performance of the bleaching material."

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (as stated in the document)
Intended Uses: Maintain substantial equivalence even with modified wording for indication [3] ("Treatment of tooth surface before and/or after bleaching").	Intended Uses: Substantially equivalent to the predicate; the modified wording [3] does not substantially affect effectiveness and performance.
Chemical Ingredients/Safety: Maintain identical chemical composition and safety profile as the predicate device.	Chemical Ingredients/Safety: The chemical composition is the same as the predicate device, thus equivalent in terms of safety.
Technological Characteristics/Effectiveness and Performance: Maintain identical technological characteristics, effectiveness, and performance.	Technological Characteristics/Effectiveness and Performance: Contains same chemical ingredients and uses same hypersensitivity-suppressing mechanism as predicate; technological characteristics/effectiveness and performance are the same.
Sealing Performance (before vs. after bleaching): No difference in sealing microcracks in enamel whether applied before or after bleaching.	No difference in sealing performance between before and after bleaching teeth (when sealing microcracks in the enamel).
Effect on Bleaching Performance: The device used before bleaching should not adversely affect the bleaching performance.	The subject device used before bleaching did not affect the bleaching performance.
Biocompatibility: Maintain identical biocompatibility as the predicate device.	Biocompatibility: All chemical ingredients are the same as the predicate; biocompatibility already shown for predicate.

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

Sample Size: Not specified. The document refers to "investigated the ability of the subject device to seal microcrecks" and "investigated the effect of the subject device on the performance of the bleaching material," but does not provide details on the sample sizes used for these investigations.
Data Provenance: Not explicitly stated. Given the context of a 510(k) submission from "Kuraray Noritake Dental Inc." which is based in Japan, it's possible the testing was conducted in Japan, but this is not confirmed. The study type appears to be internal verification.

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

Not applicable/Not specified. The document describes internal investigations rather than clinical studies involving expert consensus on ground truth.

4. Adjudication Method for the Test Set

Not applicable/Not specified.

5. 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. This is not an AI/software device, and no MRMC study was mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a dental desensitizing material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the limited investigations mentioned (sealing performance and effect on bleaching) would likely be in-vitro laboratory measurements or potentially small-scale in-vivo observations. The document states, "it was confirmed that there was no difference in sealing performance..." and "...it was confirmed that the subject device used before bleaching did not affect the bleaching performance...". This suggests direct measurement of physical properties (e.g., microcrack sealing) and functional outcomes (e.g., bleaching efficacy).

8. The sample size for the training set

Not applicable. This is a partial change application for a physical dental device. There is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set for this type of device.

Summary

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[TEETHMATE DESENSITIZER, Kuraray Noritake Dental Inc.] Section 3: Summary

Date: Aug. 27, 2013

K131068

510(k) Summary

K131068

3-1. 510(k) owner (submitter)

Name
Address
Contact person
Contact person in US

Kurarav Noritake Dental Inc.

1621 Sakazu, Kurashiki, Okayama 710-0801, Japan

Michio Takigawa Quality Assurance Department

Goro Asanuma KURARAY AMERICA, INC. 33 Maiden Lane, 6th Floor, New York, NY 10038 Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676 Fax: (212)-867-3543

3-2. Name of Device

Trade / Proprietary name
Classification name

TEETHMATE DESENSITIZER

AUG 27 2013

Calcium hydroxide cavity liner (21 CFR section 872.3250. Product code: EJK)

Tooth Desensitizer

3-3. Predicate Device

Common name
TEETHMATE DESENSITIZER

510(k) Number: Classitication: Product Code: 21 CFR Section: Applicant:

K122421 Calcium hydroxide cavity liner EJK 872.3250 Kuraray Noritake Dental Inc.

3-4. Device Description

This is an application for a partial change of the predicate device. The information of the predicate device is put on the following website.

http://www.accessdata.fda.gov/cdrh_docs/pdf12/[K122421](https://510k.innolitics.com/search/K122421).pdf.

In this application, we want to change the wording of one of the "Indications for use". In the former application dossier, the indication [3] was described as: "Treatment of tooth surface after bleaching". In this application we will change the wording of the indication [3] as follows: "Treatment of tooth surface before and/or after bleaching" in order to improve the usability for dentists based on the fact that the subject device works by physically sealing the dentinal tubules and/ or microcracks in the enamel whether before or after bleaching teeth. Accordingly, this amendment does not substantially affect the effectiveness and performance of the medical device. And the efficacy and safety of the subject device are substantially equivalent to those of the device whose "indication for use" is unchanged.

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3-5. Statement of Intended Use

TEETHMATE DESENSITIZER is indicated for reduction of tooth hypersensitivity by the following treatments:

[1] Treatment of dentin exposed by toothbrush abrasion, gingival recession, periodontal disease and/or acid erosion
[2] Treatment of dentin after mechanical tooth cleaning, scaling and/or root planing
[3] Treatment of tooth surface before and/ or after bleaching
|4| Treatment of prepared dentin for fillings and/or prosthetic restorations

3-6. Substantially Equivalence Discussion

l ) Intended uses

Predicate device	Subject device
TEETHMATE DESENSITIZER is indicatedfor reduction of tooth hypersensitivity by thefollowing treatments:	TEETHMATE DESENSITIZER is indicatedfor reduction of tooth hypersensitivity by thefollowing treatments:
[1] Treatment of dentin exposed by toothbrushabrasion, gingival recession, periodontaldisease and/or acid erosion	[1] Treatment of dentin exposed by toothbrushabrasion, gingival recession. periodontaldisease and/or acid erosion
[2] Treatment of dentin after mechanical toothcleaning, scaling and/or root planing	[2] Treatment of dentin after mechanical toothcleaning, scaling and/or root planing
[3] Treatment of tooth surface after bleaching	[3] Treatment of tooth surface before and/ orafter bleaching
[4] Treatment of prepared dentin for fillingsand/or prosthetic restorations	[4] Treatment of prepared dentin for fillingsand/or prosthetic restorations

2) Chemical ingredients / Safety

The chemical composition of subject device is the same as that of the predicate device. Therefore, the subject device is equivalent to the predicate device in terms of the safety.

3) Technological characteristics/ Effectiveness and Performance

The subject device contains the same chemical ingredients and uses the same hypersensitivity-suppressing mechanism as the predicate device, and hence it can be said that their technological characteristics/ effectiveness and performance are the same.

And it was confirmed that there was no difference in sealing performance between before and after bleaching teeth when investigated the ability of the subject device to seal microcracks in the enamel before and after bleaching. Moreover, it was confirmed that the subject device used before bleaching did not affect the bleaching performance when investigated the effect of the subject device on the performance of the bleaching material.

3-7. Biocompatibility

The subject device is categorized the external communicating device (tissue/ bone/ dentin) and of permanent contact device.

All chemical ingredients of the subject device are the same as those of the predicate device. We have already shown the biocompatibility of the predicate device in its application.

Conclusion

The test results exhibited that the subject device was substantially equivalent in effectiveness and biocompatibility to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, featuring a staff with a snake winding around it.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 27, 2013

Kuraray Noritake Dental, Incorporated Mr. Michio Takigawa Quality Assurance Department OTE Center Building 7F 1-1-3, Otemachi Chiyoda-KU, Tokyo 100-0004 JAPAN

Re: K131068

Trade/Device Name: TEETHMATE DESENSITIZER Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: II Product Code: EJK Dated: August 2, 2013 Received: August 5, 2013

Dear Mr. Takigawa:

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. 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.

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Page 2 - Mr. Takigawa

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: TEETHMATE DESENSITIZER

Indications for Use:

TEETHMATE DESENSITIZER is indicated for reduction of tooth hypersensitivity by the following treatments:

[1] Treatment of dentin exposed by toothbrush abrasion, gingival recession, periodontal disease and/or acid erosion

[2] Treatment of dentin after mechanical tooth cleaning, scaling and/or root planing

[3] Treatment of tooth surface before and/ or after bleaching

[4] Treatment of prepared dentin for fillings and/or prosthetic restorations

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ N/A (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) . .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Andrew I. Steen -S 2013.08.22 10:32:51 -04'00'

Division Sign-Off) ·vision of Anesthesiology, General Hospital ifection Control, Dental Devices

510(k) Number: 长131068

Regulation Number and Section

§ 872.3250 Calcium hydroxide cavity liner.

(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.