TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID

K122421 · Kuraray Noritake Dental, Inc. · EJK · Dec 11, 2012 · Dental

Device Facts

• Record ID: K122421
• Device Name: TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID
• Applicant: Kuraray Noritake Dental, Inc.
• Product Code: EJK · Dental
• Decision Date: Dec 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3250
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

Device consists of powder (calcium phosphate) and liquid (water) mixed to form a paste. Applied by dental professionals to affected tooth surfaces. Paste transforms into hardened hydroxyapatite material; seals dentin tubules and enamel microcracks. Mechanism suppresses hypersensitivity by blocking fluid flow within tubules. Used in clinical dental settings. Benefits patient by reducing sensitivity to temperature or air stimuli.

Clinical Evidence

Bench testing only. Evaluated dentin permeability inhibition, occlusion of dentinal tubules, and tensile bond strength to bovine dentin. Results demonstrate performance equivalent to predicate device.

Technological Characteristics

Two-component system (powder/liquid) forming hydroxyapatite paste. Principle: physical occlusion of dentinal tubules. Biocompatibility per ISO 10993 and ISO 7405. No electronic or software components.

Indications for Use

Indicated for reduction of tooth hypersensitivity in patients with dentin exposure due to abrasion, recession, periodontal disease, or acid erosion; post-mechanical cleaning/scaling/root planing; post-bleaching; or for prepared dentin prior to restorative procedures.

Regulatory Classification

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.

Predicate Devices

• SUPER SEAL (K983477)
• TEETHMATE F-1 (K012742)

Submission Summary (Full Text)

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Kizzy zi Nov. 12, 2012 Date:

## 510(k) Summary

# DEC 1 1 2012

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

1) Name

2) Address

3) Contact person

4) 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: [phone] (Ext. 115) or (800)-879-1676 Fax: [phone]

#### 3-2. Name of Device

1) Trade / Proprietary name

2) Classification name

3) Common name

#### 3-3. Predicate Device

1) SUPER SEAL

2) 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:

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

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.

#### 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. |
| Regulation<br>number | 872.3250 | 872.3250 |
| Classification<br>product code | EJK | EJK |
| Classification<br>name | Calcium hydroxide cavity liner | Calcium hydroxide cavity liner |
| Common name | Tooth Desensitizer | Tooth Desensitizer |
| Indications for<br>use | TEETHMATE DESENSITIZER is indicated<br>for reduction of tooth hypersensitivity by the<br>following treatments:<br><br>[1] Treatment of dentin exposed by toothbrush<br>abrasion, gingival recession, periodontal<br>disease and/or acid erosion<br><br>[2] Treatment of dentin after mechanical tooth<br>cleaning, scaling and/or root planing<br><br>[3] Treatment of tooth surface after bleaching<br><br>[4] Treatment of prepared dentin for fillings<br>and/or prosthetic restorations | Application prior to restoration of the tooth<br>surface or for general root sensitivity.<br><br>For all crown preparations with<br>eugenol-containing cements and<br>non-eugenol temporary cements.<br><br>On root cementum and exposed roots that<br>are sensitive to temperature or air stimuli.<br><br>On the dentin of all cavity preparations for<br>amalgam alloys and resin composite<br>restorations.<br><br>On all prepared tooth structure (vital<br>dentin), both before and after all<br>prophylaxis treatments (scaling & root<br>planing).<br><br>Following all bleaching procedures either<br>in office (power and assisted) or take home<br>systems.<br><br>Following periodontal surgery.<br><br>As a diagnostic aid to assist in<br>differentiating between reversible pulpitis<br>(hyperemia) and irreversible pulp<br>inflammation. SUPER SEAL will<br>positively affect dentin problems (fluid<br>flow mechanism) by sealing the tubules<br>and preventing fluid flow movement in the<br>tubules. |
| Technological<br>Characteristics | Occlusion of dentinal tubules:<br>The paste mixed POWDER which contains<br>calcium phosphate and LIQUID applied to<br>the affected area transforms to a hardened<br>material of hydroxyapatite and it suppresses<br>hypersensitivity by sealing the dentin tubules<br>and microcracks in the enamel. | Occlusion of dentinal tubules:<br>It demineralizes the organic and mineral<br>debris of the smear layer and the outermost<br>ring of peritubular dentin (the very hard<br>mineralized dentin of each tubule complex)<br>and restructures the demineralized material<br>as a calcium oxalate precipitate. It creates an<br>acid resistant lining layer bound both to the<br>surface as well as into the dentinal tubules. |
| Material<br>composition | 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 [phone] or [phone] 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: