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 document describes the TEETHMATE DESENSITIZER device and its substantial equivalence to a predicate device, SUPER SEAL. The manufacturer's goal is to demonstrate that the new device is as safe and effective as the predicate.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the typical sense (e.g., "sensitivity must be > 90%"). Instead, it focuses on demonstrating "substantial equivalence" to the predicate device, SUPER SEAL, in terms of effectiveness and performance. The acceptance criteria are implicitly defined by showing comparable outcomes to the predicate device across specific performance tests.

Acceptance Criteria	Reported Device Performance (TEETHMATE DESENSITIZER vs. SUPER SEAL)
Effectiveness and Performance:
Occlusion of dentinal tubules	The subject device (TEETHMATE DESENSITIZER) "transforms to a hardened material of hydroxyapatite and it suppresses hypersensitivity by sealing the dentin tubules and microcracks in the enamel." This is compared to SUPER SEAL which "demineralizes the organic and mineral debris... and restructures the demineralized material as a calcium oxalate precipitate. It creates an acid resistant lining layer bound both to the surface as well as into the dentinal tubules." Both devices achieve the goal of occluding dentinal tubules to reduce hypersensitivity, though by different mechanisms. The study concluded that the subject device was "substantially equivalent in effectiveness and performance" with respect to occlusion of dentinal tubules.
Dentin permeability inhibition	The study evaluated "dentin permeability inhibition" and concluded that the subject device was "substantially equivalent in effectiveness and performance" to the predicate device. Specific data or metrics for the inhibition were not provided in this summary.
Tensile bond strength to bovine dentin	The study evaluated "tensile bond strength to bovine dentin when used with bonding agent and composite resin" and concluded that the subject device was "substantially equivalent in effectiveness and performance" to the predicate device. Specific data or metrics were not provided in this summary.
Biocompatibility:	The subject device was evaluated referring to ISO 10993 series and ISO 7405. The results confirmed its biocompatibility, and it was concluded that the subject device was "substantially equivalent in biological safety to the predicate device."

Study Details:

Sample size used for the test set and the data provenance:
- The document does not specify the sample size for the test set for any of the performance studies (Occlusion of dentinal tubules, dentin permeability inhibition, tensile bond strength).
- The provenance for the tensile bond strength test is "bovine dentin," indicating an in vitro study using animal teeth. The provenance for the other tests is not explicitly stated but implies in vitro or potentially ex vivo lab studies, as human clinical data is not mentioned in this section.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The studies described are non-clinical, focusing on material science and dental properties rather than clinical outcomes requiring expert interpretation of patient data.
Adjudication method for the test set:
- This information is not applicable/provided. The studies are non-clinical performance tests, not clinical evaluations requiring adjudication of expert interpretations.
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 type of study was not done. This device is a dental material, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a dental material, not an algorithm. The performance evaluation is standalone in the sense that it's evaluating the material's properties directly, without human intervention in the application of the material during the test, beyond standard lab procedures.
The type of ground truth used:
- For the non-clinical performance studies ("Occlusion of dentinal tubules," "dentin permeability inhibition," and "tensile bond strength"), the "ground truth" is established through direct measurement and comparison to an established predicate device's performance using standardized laboratory methods. For biocompatibility, the ground truth is established by adherence to international standards (ISO 10993 series and ISO 7405).
The sample size for the training set:
- This information is not applicable/provided. The document describes the evaluation of a dental material, not a machine learning or AI model. Therefore, there is no "training set" in the context of AI.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device submission.

Summary

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Kizzy zi Nov. 12, 2012 Date:

510(k) Summary

DEC 1 1 2012

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

Name
Address
Contact person
Contact person in US

Kuraray Noritake Dental Inc.

1621 Sakazu, Kurashiki, Okayama 710-0801, Japan

Michio Takigawa Quality Assurance Department

Kiyoyuki Arikawa 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
Common name

3-3. Predicate Device

SUPER SEAL
TEETHMATE F-1

· TEETHMATE DESENSITIZER

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

Tooth Desensitizer

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

K983477 Calcium hydroxide cavity liner EJK 872.3250 Phoenix Dental Inc.

K012742 Pit and Fissure Sealant and Conditioner EBC 872.3765 Kuraray Noritake Dental Inc.

3-4. Device Description

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

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3-6. Substantial Equivalence Discussion

1) Intended uses

The intended uses of the subject device are substantially equivalent to the predicate device as shown on the following comparative table.

	Subject device	Predicate device
	TEETHMATE DESENSITIZER	SUPER SEAL
510(k) Number	TBD	K983477
Applicant	Kuraray Noritake Dental Inc.	Phoenix Dental Inc.
Regulationnumber	872.3250	872.3250
Classificationproduct code	EJK	EJK
Classificationname	Calcium hydroxide cavity liner	Calcium hydroxide cavity liner
Common name	Tooth Desensitizer	Tooth Desensitizer
Indications foruse	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[2] Treatment of dentin after mechanical toothcleaning, scaling and/or root planing[3] Treatment of tooth surface after bleaching[4] Treatment of prepared dentin for fillingsand/or prosthetic restorations	Application prior to restoration of the toothsurface or for general root sensitivity.For all crown preparations witheugenol-containing cements andnon-eugenol temporary cements.On root cementum and exposed roots thatare sensitive to temperature or air stimuli.On the dentin of all cavity preparations foramalgam alloys and resin compositerestorations.On all prepared tooth structure (vitaldentin), both before and after allprophylaxis treatments (scaling & rootplaning).Following all bleaching procedures eitherin office (power and assisted) or take homesystems.Following periodontal surgery.As a diagnostic aid to assist indifferentiating between reversible pulpitis(hyperemia) and irreversible pulpinflammation. SUPER SEAL willpositively affect dentin problems (fluidflow mechanism) by sealing the tubulesand preventing fluid flow movement in thetubules.
TechnologicalCharacteristics	Occlusion of dentinal tubules:The paste mixed POWDER which containscalcium phosphate and LIQUID applied tothe affected area transforms to a hardenedmaterial of hydroxyapatite and it suppresseshypersensitivity by sealing the dentin tubulesand microcracks in the enamel.	Occlusion of dentinal tubules:It demineralizes the organic and mineraldebris of the smear layer and the outermostring of peritubular dentin (the very hardmineralized dentin of each tubule complex)and restructures the demineralized materialas a calcium oxalate precipitate. It creates anacid resistant lining layer bound both to thesurface as well as into the dentinal tubules.
Materialcomposition	Calcium Phosphate, Water	Potassium oxalate, Oxalic Acid
Application	Powder/Liquid	Gel

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2) Chemical ingredients / Safety

The subject device contains new ingredients. Therefore, we evaluated the subject device referring to ISO 10993 series and ISO 7405. As the result, its biocompatibility was confirmed. The details concerning the biocompatibility of the subject device are described in "Section 9: Biocompatibility".

3 ) Technological characteristics /Effectiveness and Performance

Since there have not been any international standards concerning performance of this type of device, certain tests were performed on this device, in comparison with the predicate device and it was confirmed that this device was substantially equivalent to the predicate device in terms of the effectiveness and performance.

The brief overview of the non-clinical testing was as follows.

"Occlusion of dentinal tubules", "dentin permeability inhibition" and "tensile bond strength to bovine dentin when used with bonding agent and composite resin" were evaluated to validate the substantial equivalence of the subject device with the predicate device in terms of effectiveness and performance for the intended uses. These test results exhibited that the subject device was substantially equivalent in effectiveness and performance to the predicate device.

3-7. Biocompatibility

The safety of the subject device has been evaluated referring to ISO 10993 series and ISO 7405. As the result, it was confirmed that the device was biologically safe.

Accordingly, it was concluded that the subject device was substantially equivalent in biological safety to the predicate device.

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/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & 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 image of an eagle or bird-like figure with outstretched wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 11, 2012

Mr. Michio Takigawa Manager Kurarav Noritake Dental Incorporated Ote Center Building 7F, 1-1-3, Otemachi Chiyoda-Ku, Tokyo, Japan 100-0004

Re: K122421

Trade/Device Name: TeethMate Desensitizer Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: II Product Code: EJK Dated: November 12, 2012 Received: November 14, 2012

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. 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): K122 42)

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 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)

2012.12.11
Susan Runner DDS, MA
15:03:25 -05'00'

(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices

510(k) Number:

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.