(61 days)
Not Found
No
The document describes a dental bonding agent and its performance in standard bonding tests. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies.
No.
The device's intended use is for bonding dental restorations and desensitizing root surfaces, which are restorative and preventative measures, not therapeutic interventions aimed at treating a disease or condition.
No
The device description and intended use indicate it is a bonding system for dental restorations, not a device used to identify a disease or condition. The performance studies focus on bonding strength and dentinal tubule blockage, not diagnostic accuracy.
No
The device description clearly states it is a "bonding system" and a "single-component bonding agent," indicating it is a physical substance (a chemical or material) used for bonding, 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 listed (bonding composite restorations, repairs, root surface desensitization) are all procedures performed directly on a patient's teeth. IVDs are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health.
- Device Description: The description focuses on the chemical properties and application of the bonding agent for use in dental procedures.
- Anatomical Site: The anatomical sites mentioned (dentin, enamel, root surface) are parts of the tooth, which is consistent with a dental restorative material, not an IVD.
The information provided clearly describes a dental material used for direct application in the mouth, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
-Bonding of all direct composite restorations
-Bonding of dual/self cure composite and core build-ups
-Repairs of composite fillings
-Root surface desensitization
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
K-Bond Universal is a bonding system that offers exceptional bonding strength through a convenient single bottle application. This single-component bonding agent is specifically formulated to effectively bond various types of direct composite restorations to dentin, enamel, as well as composite.
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)
Shear bond test of the subject device (K-Bond Universal) and the predicate device (Single Bond Universal) was performed in accordance with ISO 29022. Also, we conducted dentin tubule block gevice to confirm the root surface desensitization effect.
The shear bond strength test showed that the bonding strength of the subject device is as good as the dentinal blockage test showed that the subject device also can block the dentinal tubule. Therefore, It can be considered that our subject device is as safe, effective and performs as well as or better than the predicate device.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 22, 2024
Spident Co., Ltd. Eunok Choi RA Manager 203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu Incheon, Incheon 405-821 SOUTH KOREA
Re: K241445
Trade/Device Name: K-Bond Universal Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: May 14, 2024 Received: May 22, 2024
Dear Eunok Choi:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA 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
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Indications for Use
Submission Number (if known)
Device Name
K-Bond Universal
Indications for Use (Describe)
-Bonding of all direct composite restorations
-Bonding of dual/self cure composite and core build-ups
-Repairs of composite fillings
-Root surface desensitization
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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| K241445 | ||
|---|---|---|
| 510(k) Summary | Prepared on: 2024-06-19 | |
| Contact Details | 21 CFR 807.92(a)(1) |
| Applicant Name | SPIDENT CO., LTD. |
|---|---|
| Applicant Address | 203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, |
| Incheon, Korea, 405-821 Incheon Incheon 405-821 Korea, South | |
| Applicant Contact Telephone | +821042226153 |
| Applicant Contact | Mrs. Eunok Choi |
| Applicant Contact Email | eochoi@spident.co.kr |
| Device Name | 21 CFR 807.92(a)(2) | |
|---|---|---|
| Device Trade Name | K-Bond Universal (K-Bond Universal) | |
| Common Name | Resin tooth bonding agent | |
| Classification Name | Agent, Tooth Bonding, Resin | |
| Regulation Number | 872.3200 | |
| Product Code(s) | KLE |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
|---|---|---|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K110302 | Adhesive EXL 759 (Single Bond Universal) | KLE |
| Device Description Summary | 21 CFR 807.92(a)(4) | |
|---|---|---|
| K-Bond Universal is a bonding system that offers exceptional bonding strength through a convenient single bottle application. This | ||
| single-component bonding agent is specifically formulated to effectively bond various types of direct composite restorations to dentin, | ||
| enamel, as well as composite. |
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | |
|---|---|---|
| -Bonding of all direct composite restorations | ||
| -Bonding of dual/self cure composite and core build-ups | ||
| -Repairs of composite fillings | ||
| -Root surface desensitization |
| Indications for Use Comparison | 21 CFR 807.92(a)(5) | |
|---|---|---|
| The indication for use of the subject device are all included in the indication for use of the predicate device. There are some differences | ||
| in expression, but they both can be used in bonding of all direct composite restorations, bonding of dual/self cure composite and core | ||
| build-ups, repairs of composite fillings and root surface desensitization. Therefore, this would not raise any new questions of safety and | ||
| effectiveness. |
| Technological Comparison | 21 CFR 807.92(a)(6) | |
|---|---|---|
| -------------------------- | -- | --------------------- |
Principle Operation, Biocompatibility, Application Area, Target Population of subject device are the same. The
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performance results of the subject device and predicate device are not the same, but all products meet the internal requirements (dentin : ≥15 MPa, enamel : 8 MPa).
Light curing time between the subject device is different, but the light curing time of the subject device is longer than that of the predicate device. This would not raise any new questions of safety and effectiveness. Also, both subject device and predicate device have the similar intended operator.
In case of storage condition, both products have similar limit of temperature.
Therefore, K-Bond Universal is substantially equivalent with predicate device, Single Bond Universal.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Shear bond test of the subject device (K-Bond Universal) and the predicate device (Single Bond Universal) was performed in accordance with ISO 29022. Also, we conducted dentin tubule block gevice to confirm the root surface desensitization effect.
Not Applicable
The shear bond strength test showed that the bonding strength of the subject device is as good as the dentinal blockage test showed that the subject device also can block the dentinal tubule. Therefore, It can be considered that our subject device is as safe, effective and performs as well as or better than the predicate device.