(169 days)
No
The device description and performance studies focus on the chemical and physical properties of a phosphoric acid etchant, with no mention of AI or ML.
No.
The device is an etchant used to prepare tooth surfaces for bonding, primarily a functional rather than a therapeutic treatment.
No.
The device is an etchant used to prepare tooth surfaces for bonding, not to diagnose a condition or disease.
No
The device is described as a "gel-type substance" and performance studies include physical properties like pH, viscosity, and density, as well as biocompatibility testing, indicating it is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to etch enamel and dentin to promote adhesion of dental materials. This is a direct application to the patient's tooth structure, not a test performed on a sample taken from the body.
- Device Description: The description details a substance that corrodes tooth structure, which is a physical/chemical action on the patient, not a diagnostic test.
- Lack of Diagnostic Activity: There is no mention of analyzing a sample (blood, urine, tissue, etc.) or providing information about a patient's health status or condition.
- Performance Studies: The performance studies focus on the physical properties (pH, viscosity, density) and biocompatibility of the material, which are relevant to its use as a dental etchant applied to the patient, not as a diagnostic test.
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
DiaEtch is a 37% phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
Blue colored gel-type substance containing 37% phosphoric acid that corrodes enamel and dentine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel and dentin (tooth structure)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D) / Prescription/Hospital
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)
Non-Clinical performance data:
This device has demonstrated conformance with non-clinical performance requirements through evaluation and testing in accordance with the following harmonized standards:
- ISO 7405 Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)]
- ISO 10993-1 Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process
- ISO 10993-5 Biological evaluation of medical devices - Part 5. Tests for in vitro Cytotoxicity
- ISO 10993-10 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
The following Performance tests were conducted:
- pH
- Viscosity
- Density
- Biocompatibility test
Performance test (Physical properties):
pH: 1.4 +/- 0.2
Viscosity: 60,000 cps
Density: 1.2
Biocompatibility test:
Cytotoxicity (ISO 10993-5): Pass
Sensitization (ISO 10993-10): Pass
Oral Mucosa Irritation (ISO 10993-10): Pass
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
§ 872.3200 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
February 7, 2020
Diadent Group International Kab Lee Quality Assurance Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongu-si, 28161 Kr
Re: K192273
Trade/Device Name: DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: August 1, 2020 Received: August 1, 2020
Dear Kab Lee:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K192273
Device Name DIAETCH
Indications for Use (Describe)
DiaEtch is a 37% phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Product Name : DIAETCH
510(k) Summary
1 Application Information
| Date Prepared: | February 6, 2020 |
|---|---|
| Company Name and | |
| Address: | DiaDent Group International |
| 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju- | |
| si, Chungcheongbuk-do, 28161, Republic of Korea | |
| Contact Person: | Kab Sun, Lee |
| Quality Assurance Manager | |
| Phone: +82-43-266-2315 | |
| FAX: +82-43-235-2315 | |
| Email: diadent32@diadent.co.kr |
2 Device Information
| Device Type: | Agent, Tooth Bonding, Resin |
|---|---|
| Regulation Description: | Resin tooth bonding agent. |
| Review Panel: | Dental |
| Regulation Number: | 21 CFR 872.3200 |
| Product Code: | KLE |
| Device Class: | II |
| Device Name: | DIAETCH |
3 Predicate Devices
The legally marketed devices to which substantial equivalence is being claimed are:
| Primary Predicate Device | Reference Predicate Device | |
|---|---|---|
| 510(k) Number: | K112597 | K172953 |
| Applicant: | MYCONE DENTAL SUPPLY CO., INC. | American Orthodontics |
| Device Name: | seity 37% Phosphoric Acid Etching | |
| Gel | Acid Etchant | |
| Regulation | ||
| Number: | 21 CFR 872.3200 | 21 CFR 872.3200 |
| Product Code: | KLE | KLE |
| Device Class: | II | II |
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4 Products configuration
Each models of subject device configuration is described as following:
| Model Name | Product Configuration |
|---|---|
| Economic Package Type A | Syringes with 5ml of products x 5ea |
| Disposable tips x 20ea | |
| Regular Package | Syringes with 3ml of products x 2ea |
| Disposable tips x 10ea | |
| Refill Package Type A | Syringes with 5ml of products x 1ea |
| Disposable tips x 5ea | |
| Intro Kit | Syringes with 3ml of products x 1ea |
| Disposable tips x 2ea |
5 Device Description
Blue colored gel-type substance containing 37% phosphoric acid that corrodes enamel and dentine.
6 Indications for Use
DiaEtch is a 37% phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials
7. Substantial Equivalence
| Subject Device | Primary Predicate Device | Reference Predicate Device | |
|---|---|---|---|
| Product name | DiaEtch | Seity 37% Phosphoric Acid | |
| Etching Gel | Acid Etchant | ||
| Manufacturer | DiaDent Group International | Mycone Dental | American Orthodontics |
| 510K Number | - | K112597 | K172953 |
| Product Code | KLE | KLE | KLE |
| Indications | |||
| For | |||
| Use | DiaEtch is a 37% phosphoric | ||
| acid etchant used for etching | |||
| enamel and dentin to promote | |||
| adhesion of primer/bonding | |||
| agent | |||
| adhesives | |||
| to tooth | |||
| structure | |||
| and | |||
| restorative | |||
| materials | A thixotropic 37% phosphoric | ||
| acid dental etchant gel | |||
| for | |||
| etching enamel, dentin, | |||
| and | |||
| glass | |||
| ionomer | |||
| cements | |||
| to | |||
| produce the necessary micro- | |||
| retentive surface for successful | |||
| bonding of restorations. | Acid Etchant is a phosphoric acid | ||
| etchant used for etching enamel | |||
| and dentin to promote adhesion | |||
| of | |||
| primer/bonding | |||
| agent | |||
| adhesives to tooth structure and | |||
| restorative materials. |
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Diadent Group International
Product Name : DIAETCH
| Material
Composition | -. Phosphoric acid 37%
-. Water
-. Citric acid anhydrous
-. Silicone dioxide
-. Xanthan Gum
-. Ethyl alcohol
-. Colorant | -. Phosphoric acid 37% | -. Phosphoric acid 25~50%
-. Water
-. Silicon Dioxide
-. Surfactants
-. Blue colorant |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Device
description | Thixotropic dental etchant gel
with 37% phosphoric acid | Thixotropic dental etchant gel
with 37% phosphoric acid | Thixotropic dental etchant gel
with 37% phosphoric acid |
| Physical
and
Mechanical
Properties | -. Ph : $1.4\pm0.2$
-. Viscosity : 60,000cps
-. Consistency : Thick gel
-. Color : Blue or dark blue | -. pH : 1.52
-. Viscosity : 60,000cps
-. Consistency : Thick gel
-. Color : Blue or green | -. pH_