(169 days)
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.
Blue colored gel-type substance containing 37% phosphoric acid that corrodes enamel and dentine.
The provided document describes a 510(k) premarket notification for a dental product called DIAETCH, which is a phosphoric acid etchant. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing de novo performance criteria or conducting clinical efficacy studies with human subjects.
Therefore, the acceptance criteria and study information requested in your prompt (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, effect size for human reader improvement with AI) are not applicable to this type of medical device submission. These details are typically required for AI/ML-driven devices or those requiring clinical performance data to establish safety and effectiveness.
This submission relies on non-clinical performance data to demonstrate substantial equivalence to its predicate devices (Seity 37% Phosphoric Acid Etching Gel and Acid Etchant).
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are implicitly based on demonstrating similar physical and chemical properties to the predicate devices and passing standard biocompatibility tests.
| Test | Acceptance Criteria (Implied) | DIAETCH Performance | Primary Predicate Device Performance (Seity 37% Phosphoric Acid Etching Gel) | Reference Predicate Device Performance (Acid Etchant) |
|---|---|---|---|---|
| pH | Similar to predicates | $1.4 \pm 0.2$ | 1.52 | < 2 |
| Viscosity | Similar to predicates | 60,000 cps | 60,000 cps | Thick gel (no specific value, but consistency is similar) |
| Density | (Not explicitly specified for predicates) | 1.2 | (Not specified) | (Not specified) |
| Consistency | Thick gel | Thick gel | Thick gel | Thick gel |
| Color | Blue or Dark Blue | Blue or Dark Blue | Blue or Green | Blue or Green |
| Cytotoxicity | Pass (per ISO 10993-5) | Pass | (Not explicitly stated, assumed to pass for predicate) | (Not explicitly stated, assumed to pass for predicate) |
| Sensitization | Pass (per ISO 10993-10) | Pass | (Not explicitly stated, assumed to pass for predicate) | (Not explicitly stated, assumed to pass for predicate) |
| Oral Mucosa Irritation | Pass (per ISO 10993-10) | Pass | (Not explicitly stated, assumed to pass for predicate) | (Not explicitly stated, assumed to pass for predicate) |
Regarding the other points of your request:
- 2. Sample sized used for the test set and the data provenance: Not applicable. The tests performed are laboratory-based physical/chemical and biocompatibility tests, not clinical test sets with patient data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant to this submission. Biocompatibility tests follow established standard protocols.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to clinical data adjudication, which was not part of this submission.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental etchant, not an AI-assisted diagnostic tool or system that involves human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a 510(k) for this type of device. The "ground truth" here is adherence to specified physical/chemical parameters and passing international biocompatibility standards.
- 8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable. See point 8.
In summary, the substantial equivalence for DIAETCH was demonstrated through:
- Comparison of Indications for Use: Showing that DIAETCH's intended use is substantially similar to the predicate devices.
- Comparison of Technological Characteristics: Demonstrating similar physical and chemical compositions, and properties (pH, viscosity, consistency, color).
- Non-Clinical Performance Data: Passing standard biocompatibility tests (cytotoxicity, sensitization, oral mucosa irritation) according to ISO 10993 series, which confirm the device's biological safety.
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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
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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 andAddress: | DiaDent Group International16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, Republic of Korea |
| Contact Person: | Kab Sun, LeeQuality Assurance ManagerPhone: +82-43-266-2315FAX: +82-43-235-2315Email: 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 EtchingGel | Acid Etchant |
| RegulationNumber: | 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 5eaDisposable tips x 20ea |
| Regular Package | Syringes with 3ml of products x 2eaDisposable tips x 10ea |
| Refill Package Type A | Syringes with 5ml of products x 1eaDisposable tips x 5ea |
| Intro Kit | Syringes with 3ml of products x 1eaDisposable 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 AcidEtching Gel | Acid Etchant |
| Manufacturer | DiaDent Group International | Mycone Dental | American Orthodontics |
| 510K Number | - | K112597 | K172953 |
| Product Code | KLE | KLE | KLE |
| IndicationsForUse | DiaEtch is a 37% phosphoricacid etchant used for etchingenamel and dentin to promoteadhesion of primer/bondingagentadhesivesto toothstructureandrestorativematerials | A thixotropic 37% phosphoricacid dental etchant gelforetching enamel, dentin,andglassionomercementstoproduce the necessary micro-retentive surface for successfulbonding of restorations. | Acid Etchant is a phosphoric acidetchant used for etching enameland dentin to promote adhesionofprimer/bondingagentadhesives to tooth structure andrestorative materials. |
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Diadent Group International
Product Name : DIAETCH
| MaterialComposition | -. 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 |
|---|---|---|---|
| Devicedescription | Thixotropic dental etchant gelwith 37% phosphoric acid | Thixotropic dental etchant gelwith 37% phosphoric acid | Thixotropic dental etchant gelwith 37% phosphoric acid |
| PhysicalandMechanicalProperties | -. 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_<2-. Consistency : Thick gel-. Color : Blue or green |
| Use | Prescription/Hospital | Prescription/Hospital | Prescription/Hospital |
| Delivery forms(Design) | Pre-filled syringe | Pre-filled syringes | Pre-filled syringe |
- Indications For Use
| Subject Device | Predicate Devices(K112597) | Predicate Devices(K172953) | Discussion |
|---|---|---|---|
| DiaEtch is a 37%phosphoric acid etchantused for etching enameland dentin to promoteadhesion ofprimer/bonding agentadhesives to toothstructure and restorativematerials | A thixotropic 37%phosphoric acid dentaletchant gel for etchingenamel, dentin, and glassionomer cements to producethe necessary micro-retentive surface forsuccessful bonding ofrestorations. | Acid Etchant is a phosphoricacid etchant used for etchingenamel and dentin topromote adhesion ofprimer/bonding agentadhesives to tooth structureand restorative materials. | The substance of the subjectdevice is identical with thepredicate devices (Substanceis Thixotropic dental etchantgel with 37% phosphoric acid)and the main function ofdevices is to help improveadhesion of resin/restorations.Therefore, the Indication foruse of the subject andpredicate device is notsignificantly different and thesafety and performance is notexpected to be affected bythese differences. |
-Composition
| Subject Device | Predicate Device(Primary) | Predicate Device(Reference) | Discussion |
|---|---|---|---|
| -. Phosphoric acid 37%-. Water-. Citric acid anhydrous-. Silicone dioxide-. Xanthan Gum-. Ethyl alcohol-. Colorant | -. Phosphoric acid 37%-. Water-. Additives | -. Phosphoric acid 25~50%-. Water-. Silicon Dioxide-. Surfactants-. Blue colorant | The main ingredient ofsubject and predicatedevices is Phosphoric acid.and the functions of otheradditives are similar (base,thicker, surfactants,colorant).Also, the biocompatibility ofsubject device wasconfirmed by biologicalsafety study. |
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Product Name : DIAETCH
8. 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):
| Test | DiaEtch | Primary predicate device |
|---|---|---|
| pH | $1.4 \pm 0.2$ | 1.52 |
| Viscosity | 60,000 cps | 60,000 cps |
| Density | 1.2 |
Biocompatibility test:
| Test | Standard | Test result |
|---|---|---|
| Cytotoxicity | ISO 10993-5 - Biological evaluation of medical devices -Part 5. Tests for in vitro Cytotoxicity | Pass |
| Sensitization | ISO 10993-10 - Biological Evaluation Of Medical Devices -Part 10: Tests For Irritation And Skin Sensitization | Pass |
| Oral Mucosa Irritation | ISO 10993-10 - Biological Evaluation Of Medical Devices -Part 10: Tests For Irritation And Skin Sensitization | Pass |
9. Conclusion
Based on the above information and all data provided in this submission, including comparison of intended uses, technological characteristics discussion of differences of subject and predicate devices, show that the subject device and the predicate device have similar technical characteristic and chemical composition.
It is demonstrated that the subject device and the legally marketed devices identified in this submission are substantially equivalent.
§ 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.