(124 days)
No
The device description and performance studies focus on the chemical and physical properties of the material used for desensitization, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment planning.
Yes
The device is indicated for the reduction of tooth hypersensitivity and functions by sealing dentin tubules and microcracks, which are therapeutic actions to alleviate a medical condition.
No
Explanation: The device is a desensitizer that treats tooth hypersensitivity by sealing dentin tubules and microcracks. It is not used to diagnose a condition but rather to treat one.
No
The device description clearly states it consists of a powder and a liquid that are mixed to form a paste, which is a physical material applied to the tooth. This is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a treatment applied directly to the tooth surface to reduce hypersensitivity. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a paste applied to the tooth that hardens and seals dentin tubules. This is a physical and chemical interaction with the tooth structure, not a test performed on a sample taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample (like blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth, dentin, enamel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
"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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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:
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
1
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 | ||
| number | 872.3250 | 872.3250 |
| Classification | ||
| product code | EJK | EJK |
| Classification | ||
| name | Calcium hydroxide cavity liner | Calcium hydroxide cavity liner |
| Common name | Tooth Desensitizer | Tooth 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 | Application prior to restoration of the tooth
surface or for general root sensitivity.
For all crown preparations with
eugenol-containing cements and
non-eugenol temporary cements.
On root cementum and exposed roots that
are sensitive to temperature or air stimuli.
On the dentin of all cavity preparations for
amalgam alloys and resin composite
restorations.
On all prepared tooth structure (vital
dentin), both before and after all
prophylaxis treatments (scaling & root
planing).
Following all bleaching procedures either
in office (power and assisted) or take home
systems.
Following periodontal surgery.
As a diagnostic aid to assist in
differentiating between reversible pulpitis
(hyperemia) and irreversible pulp
inflammation. SUPER SEAL will
positively affect dentin problems (fluid
flow mechanism) by sealing the tubules
and preventing fluid flow movement in the
tubules. |
| Technological
Characteristics | Occlusion of dentinal tubules:
The paste mixed POWDER which contains
calcium phosphate and LIQUID 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. | Occlusion of dentinal tubules:
It demineralizes the organic and mineral
debris of the smear layer and the outermost
ring of peritubular dentin (the very hard
mineralized dentin of each tubule complex)
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. |
| Material
composition | Calcium Phosphate, Water | Potassium oxalate, Oxalic Acid |
| Application | Powder/Liquid | Gel |
2
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.
3
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.
4
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
5
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: