(105 days)
Not Found
No
The description focuses on the chemical and physical properties of a dental adhesive and its polymerization process. There is no mention of AI, ML, image processing, or data-driven analysis.
Yes
The device is described as a dentin adhesive system used for direct and indirect restorations, desensitizing/sealing of teeth, and intra-oral repairs, which are therapeutic interventions aimed at treating or preventing damage to teeth.
No
The device is a dentin adhesive system used for restorative dentistry procedures, not for identifying the presence of a disease or condition. Its indicated uses are for direct and indirect restorations, desensitizing/sealing of teeth, and intra-oral repairs.
No
The device description clearly states it is a "dentin adhesive system" and describes a physical product that is applied to the tooth surface and polymerized. This indicates a hardware component (the adhesive material itself) is the primary function of the device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are all related to dental procedures performed directly on the tooth surface (restorations, desensitizing, repairs). These are clinical procedures, not laboratory tests performed on samples taken from the body.
- Device Description: The description clearly states it's a dentin adhesive system applied to the tooth surface and polymerized. This is a material used in a clinical setting, not a diagnostic tool.
- Anatomical Site: The anatomical sites mentioned are the tooth surface, dentin, and enamel, which are the targets of the clinical application.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the physical and biological properties of the adhesive (film thickness, bonding strength, biocompatibility), which are relevant to its function as a dental material, not its diagnostic capability.
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
-
- 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
It is a 7th generation dentin adhesive system that handles all the functions of the conditioner primer bonding resin. The polymerization method is photopolymerization type, and after being applied to the tooth surface, the solvent is volatilized and polymerized in the drying process to perform the function as a dentine adhesive.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
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 tests:
- Cytotoxicity Study (Result: Not Compatible BSE (Note: 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.))
- Bacterial Reverse Mutation Study (Result: Compatible)
- In vitro Mammalian Chromosomal Aberration Test (Result: Compatible)
- Mammalian Erythrocyte Micronucleus (Result: Compatible)
- Skin Sensitization Test (Result: Compatible)
- Oral Mucosa Irritation Test (Result: Compatible)
- Acute Systemic Toxicity (Result: 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 31, 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: K213401
Trade/Device Name: DIAPLUS Universal Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: August 29, 2021 Received: October 18, 2021
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) K213401
Device Name DIAPLUS 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
1 Application Information
| Date Prepared: | Jan 27, 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 | K213401 |
|---|---|
| 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 | DIAPLUS Universal |
3 Predicate Devices
The legally marketed devices to which substantial equivalence is being claimed are:
| Primary Predicate Device | |
|---|---|
| 510(k) Number: | K161051 |
| Applicant: | BISCO, Inc. |
| Device Name: | All-Bond Universal w/BAC |
| Regulation Number: | 21 CFR 872.3200 |
| Product Code: | KLE |
| Device Class: | II |
4 Device Configuration
DIAPLUS Universal: 1 bottle (5ml, 1ml)
5 Device Description
It is a 7th generation dentin adhesive system that handles all the functions of the conditioner primer bonding resin. The polymerization method is photopolymerization type, and after being applied to the tooth surface, the solvent is volatilized and polymerized in the drying process to perform the function as a dentine adhesive.
6 Intended Use/Indications for Use
-
- All direct restorations
-
- All indirect restorations
-
- Desensitizing/sealing of tooth
-
- Intra-oral repairs
4
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 | DIAPLUS Universal | ALL-BOND Universal w/BAC | Discussion |
| 510(k) | |||
| Number | K213401 | K161051 | - |
| Indication for | |||
| Use | 1. All direct restorations |
- All indirect restorations
- Desensitizing/sealing of tooth
- Intra-oral repairs | 1. all direct restorations
- all indirect restorations
- intra-oral repairs (i.e. repair of any
fixed dental prosthesis containing
zirconia, alumina, metals, glass
ceramics, tooth
structure, and composites) - desensitizing/sealing of tooth
structure - protective varnish for glass ionomer
fillings - priming of enamel for orthodontic
use | Equivalent |
| Composition | - 10-methacryloyloxydecyl
dihydrogenphosphate
- 2-Hydroxyethyl methacrylate
- 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 dihydrogen
phosphate - 2-hydroxyethyl methacrylate
- Bisphenol A diglycidylmethacrylate
- water
- ethanol | |
| 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. | All-Bond Universal is an
ethanol/water-based dental adhesive
which bonds to dentin and cut and un-
cut enamel. | Equivalent |
| Performance
Standard
Conformance | Conformed
ISO 4049 and ISO 29022 | Conformed
ISO 4049 and ISO 29022 | Equivalent |
| | Subject Device | Primary Predicate Device | |
| Common name | Resin tooth bonding agent. | Resin tooth bonding agent. | |
| Trade Name | DIAPLUS Universal | ALL-BOND Universal w/BAC | Discussion |
| Physical
properties | - Film thickness - Sensitivity to light
- Shear bond strength
- Occlusion of dental tubules | - Film thickness
- Shear bond strength | Equivalent |
| Biocompatibil
ity | Biocompatible | Biocompatible | Equivalent |
| Package
Contents | One bottle | One bottle | Equivalent |
| RX only/
OTC | RX Only | RX Only | equivalent |
5
Differences
-Composition
| Subject Device
(DIAPLUS Universal) | Predicate Device
(ALL-BOND Universal w/BAC) | Discussion |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| - 10-methacryloyloxydecyl
dihydrogen phosphate
- 2-Hydroxyethyl methacrylate
- 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 - (+/-) Camphor quinone
- Ethyl 4-dimethyl aminobenzoate
- tert-butyl hydroquinone
- Ethyl alcohol
- Silicon dioxide | - 10-Methacryloyloxydecyl
dihydrogen phosphate - 2-hydroxyethyl methacrylate
- Bisphenol A
diglycidylmethacrylate - water
- ethanol | The main ingredients (10-
methacryloyloxydecyl dihydrogen
phosphate, 2-Hydroxyethyl methacrylate)
are similar, with some different ingredients.
However, the results of biocompatibility
and performance tests confirm that
DIAPLUS Universal similar products are
equivalent. Performance tests confirm that
DIAPLUS Universal similar products are
equivalent. |
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 |
6
| -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 |
(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.
7