(84 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of an etching gel, with no mention of AI or ML.
No
The device is described as an etching gel used for preparing tooth surfaces and cleaning restorative materials, not for treating a disease or condition. Its function is to modify the surface for bonding, which is a preparatory step for dental restorative procedures.
No.
The device is an etching gel used to prepare tooth surfaces and dental restorative materials. Its listed intended uses and performance studies relate to its efficacy in etching and bonding, not in diagnosing conditions.
No
The device description clearly outlines physical components like etching gel, syringes, nozzles, and materials (polypropylene, polyethylene, stainless steel), indicating it is a hardware device with a chemical component, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses are "Etching of enamel and dentin" and "Cleaning of dental restorative materials." These are procedures performed directly on the tooth surface and dental materials, not on samples taken from the body for diagnostic purposes.
- Device Description: The device is an etching gel applied externally to the tooth.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose any condition or disease. Its function is purely procedural (etching and cleaning).
- Performance Studies: The performance studies focus on the physical effects of the etching process (pH, decalcification, bond strength) rather than diagnostic accuracy or measurement of biological markers.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
-
- Etching of enamel and dentin
-
- Cleaning of dental restorative materials
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
The subject device is an etching gel that consists of 35% phosphoric acid aqueous solution and colloidal silica. It allows for precise and selective placement thanks to its flowable but not runny consistency. This device is filled in a syringe made of polypropylene and polyethylene. The etching agent is applied to tooth surface through a nozzle attached to tip of the syringe. The nozzle is made of polypropylene and stainless steel(SUS304).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel and dentin, tooth surface
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)
(l) pH: It was confirmed that the pH value of the subject device was equivalent to those of the predicate devices.
(2) Enamel and dentin decalcification: It was confirmed that the etching pattern treated by the subject device was equivalent to those by the predicate devices.
(3) Tensile bond strength of a bonding agent to tooth surface which was etched: Each tensile bond strength of a bonding agent which had been used after treatment of the subject device was not statistically (P>0.05) different from the corresponding measured value of the predicate device.
(4) Tensile bond strength of a bonding agent to various prosthetic restorations which were treated by an etching agent: Each tensile the bond strength of a bonding agent which had been used after treatment of the subject device was not statistically (P>0.05) different from the corresponding measured value of the predicate device.
As the results of the above testings, it was concluded that the effectiveness and performance of the subject device were substantially equivalent to those of the predicate devices.
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.
K062409, K101485, K032455, K012740, K031968
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.
Not Found
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
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
[K-ETCHANT Syringe, Kuraray Norita Section 3: Summa
Date: November 12, 2013
510(k) Summary
3-1. 510(k) owner (submitter)
I) Name
-
Address
-
Contact person
-
Contact person in US
Kuraray 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
-
Common name
3-3. Predicate device
-
UNI ETCH
-
PANAVIA F 2.0
-
CLEARFIL AP-X
-
K-ETCHANT GEL
K-ETCHANT Syringe
Resin Tooth Bonding Agent (21 CFR section 872.3200 Product code: KLE)
Phosphoric Acid Gel
510(k) Number:
Classification:
Product Code:
Applicant:
21 CFR Section:
510(k) Number:
Classification:
Product Code:
Applicant:
21 CFR Section:
510(k) Number:
Classification:
Product Code:
Applicant:
21 CFR Section:
510(k) Number:
Classification:
Product Code:
Applicant:
21 CFR Section:
K062409 Tooth Shade Resin Material EBF 872.3690 Kuraray Noritake Dental Inc.
K101485 Resin Tooth Bonding Agent KLE 872.3200 Bisco, Inc.
K032455 Dental Cement EMA 872.3275 Kuraray Noritake Dental Inc.
K012740 Tooth Shade Resin Material EBF 872.3690 Kuraray Noritake Dental Inc.
- CERABIEN ZR 510(k) Number: K031968 Classification: Porcelain Powder for clinical use Product Code: EIH 21 CFR Section: 872.6660 Applicant: Kuraray Noritake Dental Inc.
1
3-4. Device Description
The subject device is an etching gel that consists of 35% phosphoric acid aqueous solution and colloidal silica. It allows for precise and selective placement thanks to its flowable but not runny consistency.
This is the new registration application for the subject device and there have not been any prior submissions regarding the subject device.
This device is filled in a syringe made of polypropylene and polyethylene. The etching agent is applied to tooth surface through a nozzle attached to tip of the syringe. The nozzle is made of polypropylene and stainless steel(SUS304).
3-5. Statement of Intended Use
-
- Etching of enamel and dentin
-
- Cleaning of dental restorative materials
3-6. Substantial Equivalence Discussion
-
l) Intended uses
The intended use of the subject device was written up based on that of the predicate devices. Therefore, the intended use of the subject device is substantially equivalent to that of the predicate devices. -
- Chemical ingredients/ Safety
The subject device, K-ETCHANT GEL and UNI ETCH contain similar amount of phosphoric acid.
- Chemical ingredients/ Safety
All ingredients in the subject device have been used in the predicate devices. Regarding the predicate devices, there have not been any reported problems or recalls according to the post market adverse event reporting requirements in the US. In conclusion, it can be said that the safety of the subject device is substantially equivalent to that of the predicate devices.
-
- Technological characteristics/ Effectiveness and Performance
K-ETCHANT GEL, one of the predicate devices, is filled in a bottle, while the subject device is filled in a syringe as the other predicate device. UNI ETCH. The dimension and materials of the subject device's syringe are similar as those of the UNI ETCH's.
- Technological characteristics/ Effectiveness and Performance
Both the subject device and UNI ETCH are directly applied to tooth surface through a nozzle attached to the tip of syringe. On the other hand, K-ETCHANGT GEL is once dispensed to a mixing dish and applied to tooth surface with a small brush.
Since there have not been any international standards concerning performance of this type of device, certain tests were performed on this device considering its intended uses, in comparison with the predicate devices.
The test items and brief description of the results are as follows.
(l) pH:
It was confirmed that the pH value of the subject device was equivalent to those of the predicate devices.
-
(2) Enamel and dentin decalcification:
It was confirmed that the etching pattern treated by the subject device was equivalent to those by the predicate devices. -
(3) Tensile bond strength of a bonding agent to tooth surface which was etched: Each tensile bond strength of a bonding agent which had been used after treatment of the subject device was not statistically (P>0.05) different from the corresponding measured value of the predicate device.
-
(4) Tensile bond strength of a bonding agent to various prosthetic restorations which were treated by an etching agent:
Each tensile the bond strength of a bonding agent which had been used after treatment of the subject device was not statistically (P>0.05) different from the corresponding measured value of the predicate device.
As the results of the above testings, it was concluded that the effectiveness and performance of the subject device were substantially equivalent to those of the predicate devices. Accordingly, it was concluded that the effectiveness and performance of the subject device
2
were substantially equivalent to those of the predicate devices.
3-7. Biocompatibility
The subject device is categorized into the external communicating device that may contact dentin and whose duration of contact is less than 24 hours.
All the chemical ingredients of the subject device are equivalent to those of the predicate devices.
Regarding the predicate devices, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US.
Accordingly, it was considered that the subject device was substantially equivalent in safety to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2013
Kuraray Noritake Dental Incorporated C/O Mr. Goro Asanuma General Manager Kuraray America, Incorporated 33 Maiden Lane, 6th Floor New York, NY 10038
Re: K133078
Trade/Device Name: K-ETCHANT Syringe Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: November 19, 2013 Received: November 21, 2013
Dear Mr. Asanuma:
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. Asanuma
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 Biomctrics/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 vours.
Image /page/4/Picture/8 description: The image shows the text "Kwame O. Ulmer-S" in a bold, sans-serif font. The text is arranged in two lines, with "Kwame O." on the top line and "Ulmer-S" on the bottom line. Behind the text, there are some geometric shapes, including a circle and a triangle, which appear to be part of a logo or design element.
for
Erin I. Keith, M.S. Acting 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
K133078 510(k) Number (if known):
Device Name: K-ETCHANT Syringe
Indications for Use:
-
Etching of enamel and dentin
-
Cleaning of dental restorative materials
Prescription Use _ 1 (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)
Susan Runner
Mary S. Runner -5
2019
18:15:05'00"