(366 days)
K81380
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a dental bonding adhesive, with no mention of AI or ML technologies.
No
The device is a bonding adhesive used for dental restorations, which is a material rather than a device designed to treat or prevent a disease or condition directly.
No
Explanation: The device description states its purpose is for bonding dental restorations and procedures, and it consists of methylmethacrylates and solvent that polymerize to form a strong bonding membrane. This is a material used in treatment, not for diagnosing conditions.
No
The device description clearly states the device is a dental bonding adhesive composed of chemical substances (methylmethacrylates and solvent) that are applied and polymerized, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for bonding in dental restoration procedures. This is a therapeutic and restorative application, not a diagnostic one.
- Device Description: The description details a bonding adhesive used to create a strong membrane for dental procedures. This aligns with a material used in vivo (within the body) for treatment, not a test performed in vitro (outside the body) to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing information for diagnosis or monitoring of a disease or condition.
- Performance Studies: The performance studies focus on biocompatibility and bench testing related to the physical properties and bonding strength of the adhesive, which are relevant for a dental material used in treatment. They do not involve evaluating diagnostic accuracy.
IVD devices are specifically designed 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
Bonding for all Classes of direct composite restoration
Bonding for indirect procedures involving metal, porcelain and composite
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
DX. Bond V Dental Bonding Adhesive is a multi-purpose dental bonding adhesive for all classes of direct composite restoration as well as for indirect procedures involving metal, porcelain and composite. DX. Bond V is also used for amalgam, self- cure composite and orthodontic brackets bonding. DX. Bond V consists of methylmethacrylates and solvent. After applied to bonding area with thin layer, methylmethacrylates are initiated by free radical with blue light and then polymerized to form cross-linking polymer network resulting in solid and strong bonding membrane. The adhesive is dropped onto a mixing pad before application.
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)
Biocompatibility testing:
DX. Bond V Dental Bonding Adhesive is considered a communicating device in long term contact with tissue/bone/dentin. A biological risk assessment and testing were conducted to assess the biocompatibility of the DX. Bond V:
- Cytotoxicity tests (ISO 10993-5:2009)
- Sensitivity Test (ISO 10993-10:2010)
- Irritation Test (ISO 10993-23:2021)
- Acute Systemic toxicity (ISO 10993-11:2017)
- Genotoxicity (ISO 10993-3:2014).
The results of the biocompatibility testing and risk assessment demonstrates a low potential for an unacceptable adverse biological response from contact of the component materials of the device with the body.
Non-clinical performance data:
Bench testing was conducted to determine the performance of the DX. Bond V compared to the predicate devices. The tests performed were:
- Film thickness: ISO 4049:2010
- Shear bonding: ISO/TS 11405:2015; ISO29022:2013
- Light sensitivity: ISO 4049:2010
- Microleakage: ISO/TS 11405:2015
Bench testing demonstrated the DX. Bond V Dental Bonding Adhesive met the relevant ISO standard requirement, where applicable, and performed comparably to the predicate devices for the parameters tested.
Clinical performance data:
This section is not applicable.
Electrical safety and electromagnetic compatibility (EMC):
This section is not applicable.
Software verification and validation testing:
This section is not applicable.
Mechanical and acoustic testing:
This section is not applicable.
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.
K81380
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 & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
September 22, 2023
Sino-Dentex Co., Ltd. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K232978
Trade/Device Name: DX. Bond V Dental Bonding Adhesive Regulation Number: 21 CFR 872.3200 Regulation Name: Resin tooth bonding agent Regulatory Class: Class II Product Code: KLE Dated: September 21, 2023 Received: September 21, 2022
Dear Prithul Bom:
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.
1
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 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 -S
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
DX. Bond V Dental Bonding Adhesive (Universal-003, Universal-005)
Indications for Use (Describe)
[ Bonding for all Classes of direct composite restoration
[ Bonding for indirect procedures involving metal, porcelain and composite
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.
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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."
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Image /page/3/Picture/1 description: The image shows the logo for DENTEX. The word "DENTEX" is written in a bold, sans-serif font and is blue. Below the word "DENTEX" is the Chinese translation of the word. To the right of the Chinese translation is the registered trademark symbol.
DX. Bond V Dental Bonding Adhesives Traditional 510(k) Notification
SINO-DENTEX CO.,LTD.
Kxxxxxxx
510 K SUMMARY
1. SUBMITTER INFORMATION
| Applicant Information: | SINO-DENTEX CO.,LTD.
721Chenggong Road,
High-Tech Development District, Changchun,
Jilin P.R. China,130000
Email: dentex-ypt@163.com
Tel: (086) 18943173317
Fax: (086) 431-87855157 |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer Contact: | SINO-DENTEX CO., LTD.
721Chenggong Road, High-Tech Development
District, Changchun, Jilin P.R. China,130000
Contact: Pengtao Yan
Owner Operator Number: 10083627
Facility Registration Number: 3018283083
Email: dentex-ypt@163.com
Tel: (086) 18943173317
Fax: (086) 431-87855157 |
| Summary Preparation Date: | 8/25/2023 |
| Type of 510(k) Submission: | Traditional 510 (k) |
| 2. DEVICE DETAIL: | |
| Device Classification Name:
Device Trade Name:
Common Name:
Model Number: | Agent, tooth bonding, resin
DX. Bond V Dental Bonding Adhesive
Dental Bonding Adhesive
Universal-003, Universal-005 |
21 CFR 872.3200
Regulation Number:
4
Image /page/4/Picture/0 description: The image contains the logo for DENTEX. The word "DENTEX" is written in blue, block letters at the top of the image. Below the word "DENTEX" is the Chinese translation of the word, also written in blue. To the right of the Chinese translation is the registered trademark symbol.
SINO-DENTEX CO.,LTD.
| Regulation Medical Specialty: | Dental |
|---|---|
| Regulatory Class: | Class II |
| Product Code: | KLE |
3. LEGALLY MARKETED PREDICATE DEVICE:
| Device Classification Name: | Agent, tooth bonding, resin |
|---|---|
| Device Trade Name: | Scotchbond Dental Adhesive |
| Common Name: | Dental Bonding Adhesive |
| Regulation Number: | 21 CFR 872.3200 |
| Regulation Medical Specialty: | Dental |
| Regulatory Class: | Class II |
| Product Code: | KLE |
| 510 K: | K81380 |
| Manufacture: | 3M |
4. DEVICE DESCRIPTION:
DX. Bond V Dental Bonding Adhesive is a multi-purpose dental bonding adhesive for all classes of direct composite restoration as well as for indirect procedures involving metal, porcelain and composite. DX. Bond V is also used for amalgam, self- cure composite and orthodontic brackets bonding. DX. Bond V consists of methylmethacrylates and solvent. After applied to bonding area with thin layer, methylmethacrylates are initiated by free radical with blue light and then polymerized to form cross-linking polymer network resulting in solid and strong bonding membrane. The adhesive is dropped onto a mixing pad before application.
5. INDICATIONS FOR USE:
1.Bonding for all Classes of direct composite restoration 2.Bonding for indirect procedures involving metal, porcelain, and composite
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCIE:
Both Dentex DX. Bond V Dental Bonding Adhesive and the predicate device 3M Scotchbond Dental Adhesive have similar chemistry composition. Both use
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Image /page/5/Picture/0 description: The image shows a logo for a company called "DENTEX". The word "DENTEX" is written in blue, bold letters with a rounded rectangle around it. Below the word "DENTEX" are three Chinese characters, also in blue. To the right of the Chinese characters is the registered trademark symbol.
SINO-DENTEX CO.,LTD.
BisGMA, HEMA as main monomer, and Camphorquinone/ Ethyl-4-dimethyl amino benzoate as initiator system. The major difference is solvent and ethylene dimethacrylate monomer. Dentex DX. Bond V Dental Bonding Adhesive utilizes acetone/ethanol as the solvents and the predicate devices only has ethanol in it. Acetone/ethanol combination is more volatile for reduction of any residual solvent on bonding body which may decrease the curability of the adhesive. Both ethanol and acetone are common materials in dental application and evaporated in short time after application. Dentex DX. Bond V Dental Bonding Adhesive is added with Ethylene dimetharylate monomer which has been applied extensively in dental restorative materials for many years. Its major function is to dilute thick BisGMA. So, the difference has not affected the safety and effectiveness of the device.
7. PERFORMANCE DATA
Biocompatibility testing
DX. Bond V Dental Bonding Adhesive is considered a communicating device in long term contact with tissue/bone/dentin. A biological risk assessment and testing were conducted to assess the biocompatibility of the DX. Bond V:
- Cytotoxicity tests (ISO 10993-5:2009) ●
- Sensitivity Test (ISO 10993-10:2010)
- Irritation Test (ISO 10993-23:2021)
- Acute Systemic toxicity (ISO 10993-11:2017) ●
- . Genotoxicity (ISO 10993-3:2014).
The results of the biocompatibility testing and risk assessment demonstrates a low potential for an unacceptable adverse biological response from contact of the component materials of the device with the body.
Non-clinical performance data
Bench testing was conducted to determine the performance of the DX. Bond V compared to the predicate devices. The tests performed were:
- Film thickness: ISO 4049:2010 ●
- . Shear bonding: ISO/TS 11405:2015; ISO29022:2013
- Light sensitivity: ISO 4049:2010 ●
6
Image /page/6/Picture/0 description: The image shows a logo for a company called "DENTEX". The word "DENTEX" is written in blue, bold letters with a rounded rectangle around it. Below the word "DENTEX" are three Chinese characters, also in blue. To the right of the Chinese characters is the registered trademark symbol.
SINO-DENTEX CO.,LTD.
- Microleakage: ISO/TS 11405:2015 ●
Bench testing demonstrated the DX. Bond V Dental Bonding Adhesive met the relevant ISO standard requirement, where applicable, and performed comparably to the predicate devices for the parameters tested.
Clinical performance data
This section is not applicable.
Electrical safety and electromagnetic compatibility (EMC)
This section is not applicable.
Software verification and validation testing
This section is not applicable.
Mechanical and acoustic testing
This section is not applicable.
8. CONCLUSION REGARDING SUBSTANTIAL EQUIVALENCE
The conclusions drawn from the bench and biocompatibility tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as the legally marketed predicate device, 3M Scotchbond Dental Adhesive cleared under K813180.