(132 days)
No
The device description and performance studies focus on the chemical and physical properties of the material for sealing dentin tubules and microcracks, with no mention of AI or ML.
Yes
The device is indicated for the reduction of tooth hypersensitivity and transforms into a hardened material that suppresses hypersensitivity by sealing dentin tubules and microcracks, which are therapeutic actions.
No
This device is indicated for the reduction of tooth hypersensitivity by treating and sealing dentin tubules and microcracks, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it consists of "POWDER" and "LIQUID" which are mixed to form a paste, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a treatment applied directly to the tooth surface to reduce hypersensitivity by sealing dentin tubules and microcracks. This is a therapeutic action performed on the patient's body.
- Device Description: The device is a paste applied to the tooth surface that hardens into hydroxyapatite. This is a material applied externally to the body for a therapeutic effect.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples (like blood, urine, tissue, etc.) outside of the body to diagnose a condition or provide information about a patient's health status. The performance studies described focus on the device's sealing ability and effect on bleaching, which are related to its therapeutic function on the tooth.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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
Product codes
EJK
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth/Dentin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
[TEETHMATE DESENSITIZER, Kuraray Noritake Dental Inc.] Section 3: Summary
Date: Aug. 27, 2013
K131068
510(k) Summary
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
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.
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.
1
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 indicated | |
| for reduction of tooth hypersensitivity by the | |
| following treatments: | 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 | [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 | [2] Treatment of dentin after mechanical tooth |
| cleaning, scaling and/or root planing | |
| [3] Treatment of tooth surface after bleaching | [3] Treatment of tooth surface before and/ or |
| after bleaching | |
| [4] Treatment of prepared dentin for fillings | |
| and/or prosthetic restorations | [4] Treatment of prepared dentin for fillings |
| and/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.
2
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.
3
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
4
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