(89 days)
Not Found
No
The description focuses on the chemical composition and bonding properties of a dental adhesive, with no mention of AI or ML. The performance studies are standard biocompatibility and physical property tests for dental materials.
No
This device is a universal adhesive for dental restorations, designed for bonding and sealing, not for treating or preventing disease.
No
The device, Dia-X Bond Universal, is an adhesive used for direct and indirect restorations and desensitizing teeth. Its intended use is to bond materials to the tooth, not to diagnose a condition or disease.
No
The device description clearly states it is a "single bottle of etching, primer, and adhesive resin," indicating it is a physical chemical product, not software. The performance studies also focus on material properties and biocompatibility, consistent with a physical substance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly indicate that this product is a dental adhesive used for bonding restorations directly to the tooth. It is applied to the tooth, not used to analyze a sample taken from the body.
- The description focuses on the chemical composition and application of the adhesive. There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information.
- The performance studies are related to the physical and biological properties of the adhesive, such as bonding strength, film thickness, and biocompatibility, which are relevant to its function as a dental material, not a diagnostic tool.
Therefore, Dia-X Bond Universal is a dental material used for restorative procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- All direct restorations
- All indirect restorations
- Desensitizing/sealing of tooth
- Intra-oral repairs
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
Dia-X Bond Universal is a universal adhesive capable of total, self, and selective etching as it consists of a single bottle of etching, primer, and adhesive resin. It can be used for both direct bonding of restorations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-Clinical performance data:
- Film Thickness
- Shear Bonding Strength
- Sensitivity to Ambient Light
- Occlusion of dentinal tubules
Biocompatibility tests:
- Cytotoxicity Study: Not Compatible BSE
- Bacterial Reverse Mutation Study: Compatible
- In vitro Mammalian Chromosomal Aberration Test: Compatible
- Mammalian Erythrocyte Micronucleus: Compatible
- Skin Sensitization Test: Compatible
- Oral Mucosa Irritation Test: Compatible
- Acute Systemic Toxicity: Compatible
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.
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
June 15, 2022
Diadent Group International Kab Lee Quality Assurance Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si, Chungcheongbuk-do 28161 SOUTH KOREA
Re: K220804
Trade/Device Name: Dia-X Bond Universal Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: May 11, 2022 Received: May 16, 2022
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220804
Device Name Dia-X Bond Universal
Indications for Use (Describe)
- All direct restorations
- All indirect restorations
- Desensitizing/sealing of tooth
- Intra-oral repairs
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Diadent Group International
Special 510(k) Summary
1 Application Information
| Date Prepared: | May 11, 2022 |
|---|---|
| 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
| 510(k) Number | K220804 |
|---|---|
| Classification Name | Agent, Tooth Bonding, Resin |
| Common Name | Resin tooth bonding agent. |
| Review Panel: | Dental |
| Regulation Number: | 21 CFR 872.3200 |
| Product Code: | KLE |
| Device Class: | II |
| Trade Name | Dia-X Bond Universal |
3 Predicate Devices
The legally marketed devices to which substantial equivalence is being claimed are:
| Primary Predicate Device | |
|---|---|
| 510(k) Number: | K213401 |
| Applicant: | DiaDent Group International |
| Device Name: | DIAPLUS Universal |
| Regulation Number: | 21 CFR 872.3200 |
| Product Code: | KLE |
| Device Class: | II |
4 Device Configuration
Dia-X Bond Universal: 1 bottle (5ml, 1ml)
5 Device Description
Dia-X Bond Universal is a universal adhesive capable of total, self, and selective etching as it consists of a single bottle of etching, primer, and adhesive resin. It can be used for both direct bonding of restorations.
6 Intended Use/Indications for Use
- All direct restorations
- All indirect restorations
- Desensitizing/sealing of tooth
- Intra-oral repairs
4
Diadent Group International
7 Comparison Table and Discussion
This device compares to the legally marketed devices as follows:
| Subject Device | Primary Predicate Device | ||
|---|---|---|---|
| Common name | Resin tooth bonding agent. | Resin tooth bonding agent. | |
| Trade Name | Dia-X Bond Universal | DIAPLUS Universal | Discussion |
| 510(k) | |||
| Number | K220804 | K213401 | |
| Indication for | |||
| Use | - All direct restorations |
- All indirect restorations
- Desensitizing/sealing of tooth
- Intra-oral repairs | - All direct restorations
- All indirect restorations
- Desensitizing/sealing of tooth
- Intra-oral repairs | Equivalent |
| Composition | - 10-methacryloyloxydecyl
dihydrogenphosphate - 2-Hydroxyethyl methacryalate
- Bis[2-(methacryloyloxy)ethyl]
phosphate - 3-(Trimethoxysilyl)propyl
methacrylate - Trimethylolpropane trimethacrylate
- BisGMA/TEGDMA Monomer Blend
- Poly(ethylene glycol) dimethacrylate
- Diphenyliodonium
hexafluorophosphate - Phenyl Bis(2,4,6-
Trimethylbenzoyl)phosphineoxide - (+/-)Camphorquinone
- Ethyl 4-dimethyl aminobenzoate
- tert-butyl hydroquinone
- Ethyl alcohol
- Silicon dioxide | - 10-methacryloyloxydecyl
dihydrogenphosphate - 2-Hydroxyethyl methacryalate
- Bis[2-(methacryloyloxy)ethyl]
phosphate - 3-(Trimethoxysilyl)propyl
methacrylate - Trimethylolpropane trimethacrylate
- BisGMA/TEGDMA Monomer Blend
- Poly(ethylene glycol) dimethacrylate
- Diphenyliodonium
hexafluorophosphate - Phenyl Bis(2,4,6-
Trimethylbenzoyl)phosphineoxide - (+/-)Camphorquinone
- Ethyl 4-dimethyl aminobenzoate
- tert-butyl hydroquinone
- Ethyl alcohol
- Silicon dioxide | Equivalent |
| Principle of
operation | After being applied to the tooth
surface, the solvent is volatilized and
photopolymerized in the drying
process to perform the function as a
dentin adhesive. The main material,
MDP contains a hydrophobic long
carbon chain and a hydrophilic
phosphate group, so it has excellent
surface activity and can easily
permeates dentin & enamel. It
increases bonding to hydroxyapatite
remaining in dentin. | After being applied to the tooth
surface, the solvent is volatilized and
photopolymerized in the drying
process to perform the function as a
dentin adhesive. The main material,
MDP contains a hydrophobic long
carbon chain and a hydrophilic
phosphate group, so it has excellent
surface activity and can easily
permeates dentin & enamel. It
increases bonding to hydroxyapatite
remaining in dentin. | Equivalent |
| Performance
Standard
Conformance | Conformed
ISO 4049 and ISO 29022 | Conformed
ISO 4049 and ISO 29022 | Equivalent |
| Physical
properties | - Film thickness - Sensitivity to light
- Shear bond strength
- Occlusion of dental tubules | - Film thickness
- Sensitivity to light
- Shear bond strength
- Occlusion of dental tubules | Equivalent |
| Biocompatibil
ity | Biocompatible | Biocompatible | Equivalent |
| Package
Contents | One bottle | One bottle | Equivalent |
| RX only/
OTC | RX Only | RX Only | Equivalent |
5
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 4049 | Dentistry -- Polymer-based restorative materials |
|---|---|
| -ISO 7405 | Dentistry - Evaluation of Biocompatibility of Medical Devices Used In Dentistry |
| [Including: Amendment 1 (2013)] | |
| -ISO 29022 | Dentistry - Adhesive - Notched-edge sheer bond strength test |
| -ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a |
| risk management process | |
| -ISO 10993-3 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity |
| carcinogenicity and reproductive toxicity | |
| -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 | |
| -ISO 10993-11 | Biological evaluation of medical devices - Part 11: Tests for Systemic toxicity |
The following Performance tests were conducted.
- Film Thickness
- Shear Bonding Strength
- Sensitivity to Ambient Light
- Occlusion of dentinal tubules
Biocompatibility test:
| Test | Standard | Test result |
|---|---|---|
| Cytotoxicity Study | •10993-5 - Biological Evaluation of Medical Devices - | |
| Part 5: Tests for In Vitro Cytotoxicity | Not | |
| Compatible | ||
| BSE | ||
| Bacterial Reverse | ||
| Mutation Study | •10993-3 - Biological Evaluation of Medical Devices - | |
| Part 3: Tests for genotoxicity, carcinogenicity and | ||
| reproductive toxicity | Compatible | |
| In vitro Mammalian | ||
| Chromosomal | ||
| Aberration Test | •10993-3 - Biological Evaluation of Medical Devices - | |
| Part 3: Tests for genotoxicity, carcinogenicity and | ||
| reproductive toxicity | Compatible | |
| Mammalian | ||
| Erythrocyte | ||
| Micronucleus | •10993-3 - Biological Evaluation of Medical Devices - | |
| Part 3: Tests for genotoxicity, carcinogenicity and | ||
| reproductive toxicity | Compatible | |
| Skin Sensitization | ||
| Test | •10993-10 - Biological Evaluation of Medical Devices - | |
| Part 10: Tests for Irritation and Skin Sensitization | Compatible | |
| Oral Mucosa | ||
| Irritation Test | •10993-10 - Biological Evaluation of Medical Devices - | |
| Part 10: Tests for Irritation and Skin Sensitization | Compatible | |
| Acute Systemic | ||
| Toxicity | •10993-11 - Biological Evaluation of Medical Devices - | |
| Part 11: Tests for Systemic Toxicity | Compatible |
6
Diadent Group International
(Among the components of this product, 10-MDP is an acidic monomer, and depending on the acidity, it is a substance that causes cytotoxicity according to the principle of action of this product, so cytotoxicity test setting the test item is meaningless.
9 Clinical Performance Data
No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices.
10. Conclusion
Based on the above information and all data provided in this submission, the comparison of intended uses, technological characteristics, and non-clinical performance testing demonstrates that the subject device is substantially equivalent to the legally marketed devices identified in this submission.