(90 days)
No
The device description and performance studies focus on the chemical composition and physical properties of a dental adhesive, with no mention of AI or ML.
No.
The device is a dental adhesive used for various restorative and protective dental procedures, not for treating diseases or conditions.
No
The device description and intended uses indicate it is a dental adhesive for restoration and sealing, not for diagnosing conditions.
No
The device description clearly states it is a "light-curing dentin adhesive system composed of several resin monomers, inorganic fillers, polymerization-related initiators and accelerators, ethyl alcohol, and antioxidants." This describes a chemical substance, not software. The performance studies also focus on physical properties like film thickness, polymerization depth, and adhesive strength, further indicating a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to dental procedures performed directly on the patient's tooth structure (restorations, repairs, desensitizing, sealing, priming). These are clinical applications, not laboratory tests performed on samples taken from the body.
- Device Description: The description details a dental adhesive system used for bonding materials to tooth structure. This aligns with a clinical dental product, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the physical and adhesive properties of the material in relation to dental applications (film thickness, polymerization depth, adhesive strength, pH, dentinal tubule blockage). These are relevant to the device's function in a clinical setting, not its diagnostic accuracy.
In summary, the Hi-Bond Universal is a dental material used for bonding and sealing tooth structure during restorative and other dental procedures. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
-
- 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
Product codes
KLE, EBF, LBH
Device Description
The Hi-Bond Universal is a light-curing dentin adhesive system composed of several resin monomers, inorganic fillers, polymerization-related initiators and accelerators, ethyl alcohol, and antioxidants. The Hi-Bond Universal is a light-curing type dental adhesive offering etching. priming, and bonding at once. The Hi-Bond Universal is packaged in a bottle made of polyethylene and polypropylene, and then packaged in a box.
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
The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.
- Appearance
- Volume Accuracy
- Packing
- Film Thickness in accordance with ISO 4049
- Sensitivity to ambient light in accordance with ISO 4049
- Polymerization depth in accordance with ISO 4049
- Adhesive strength (Dentin, self-etch) in accordance with ISO 11405
- Adhesive strength (Enamel, total-etch) in accordance with ISO 11405
- pH
- Dentinal tubule blockage
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
May 22, 2023
Mediclus Co., LTD. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave Ste 160 Irvine, California 92612
Re: K230465
Trade/Device Name: Hi-Bond Universal Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE, EBF, LBH Dated: February 21, 2023 Received: February 21, 2023
Dear Priscilla Chung:
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 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 -5
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 Page 2
Enclosure
2
Indications for Use
510(k) Number (if known) K230465
Device Name Hi-Bond Universal
Indications for Use (Describe)
-
- 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
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)
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
K230465 - 510(k) Summary
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Feb 21, 2023 Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date:
1. Applicant / Submitter:
MEDICLUS CO., LTD. No. 1210, 134 Gongdan-ro, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea Tel : +82-43-211-2877 Fax : +82-43-211-2866
Submission Correspondent: 2.
Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com
3. Device:
| Proprietary Name: | Hi-Bond Universal |
|---|---|
| Common Name: | Dental adhesive material |
| Classification Name: | Agent, Tooth Bonding, Resin |
| Classification: | Class II, 21 CFR 872.3200 |
| Classification Product Code: | KLE |
PrimaryPredicate Device: 4.
All-Bond Universal w/ BAC (K161051) by Bisco, Inc.
4
5. Device Description:
The Hi-Bond Universal is a light-curing dentin adhesive system composed of several resin monomers, inorganic fillers, polymerization-related initiators and accelerators, ethyl alcohol, and antioxidants. The Hi-Bond Universal is a light-curing type dental adhesive offering etching. priming, and bonding at once. The Hi-Bond Universal is packaged in a bottle made of polyethylene and polypropylene, and then packaged in a box.
6. Indications for Use:
-
- 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
7. Performance Data (Non-Clinical):
The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.
- Appearance
- Volume Accuracy
- Packing
- Film Thickness in accordance with ISO 4049 ■
- Sensitivity to ambient light in accordance with ISO 4049
- Polymerization depth in accordance with ISO 4049
- Adhesive strength (Dentin, self-etch) in accordance with ISO 11405
- Adhesive strength (Enamel, total-etch) in accordance with ISO 11405
- pH
- Dentinal tubule blockage
8. Substantial Equivalence
8.1. Comparison Chart
| Subject Device | Predicate Device | |
|---|---|---|
| 510(K) Number | - | K161051 |
| Device Name | Hi-Bond Universal | All-Bond Universal w/ BAC |
| Manufacturer | MEDICLUS CO., LTD. | Bisco, Inc. |
| Product Code | KLE | KLE |
5
| Design | Image: Hi-Bond bottle | Image: All-Bond Universal bottle | |
|---|---|---|---|
| Indications for Use | 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 | 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 | |
| Method of
polymerization | Light Cured | Light Cured | |
| Material Composition | - 10-Methacryloyl-oxydecyl
dihydrogen phosphate
- 2-Hydroxyethyl methacrylate
- Bisphenol A glycerolate
Dimethacrylate - Water
- Ethanol
- Ethyl 4-dimethylaminobenzoate | - 10-Methacryloyl-oxydecyl
dihydrogen phosphate - 2-Hydroxyethyl methacrylate
- Bisphenol A diglycidylmethacrylate
- Water
- Ethanol | |
| Method of application | Single component adhesive | Single component adhesive | |
| Physical /
Mechanical
Property
Comparison | Film
thickness
Etch
Methods | 12μm | 3.4μm |
| | | Self-etch and total-etch | Self-etch and total-etch |
8.2. Substantial Equivalence Discussion
The subject device has the same indications for use statement as well as technological characteristics as the predicate device (K161051, All-Bond Universal w/ BAC). Both devices are a single component system offering self-etching and total etching. The difference is in chemical compositions; however, the test results of biocompatibility and performance tests supports that the subject device is substantially equivalent to the predicate device.
9. Conclusion:
Based on the information submitted herein, MEDICLUS CO., LTD. concludes that the Hi-Bond Universal is substantially equivalent to the predicate device.