(59 days)
Not Found
No
The summary describes a light-curing composite material for dental restorations and does not mention any AI or ML components or functionalities.
No
The device is a light-curing composite material used for dental restorations, which is a material rather than a therapeutic device that actively treats disease or injury.
No
The device description indicates it is a "Light Cure Composite" for "restorative therapy," which means it is used to repair or restore teeth, not to diagnose a condition.
No
The device description clearly states it is a "paste contained in PP syringe" and is a "light-curing, radiopaque, nano-hybrid composite," 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 clearly describes a material used for restoring teeth (filling cavities, veneering, splinting). This is a direct treatment applied to the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a light-curing composite paste for restorative therapy. This aligns with a dental material used for treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
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
Anterior restorations (Class III, IV) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Restorations in the posterior region (Class I and II) Veneering of discolored anterior teeth Splinting of mobile teeth Repair of composite and ceramic veneers
Product codes
EBF
Device Description
Light Cure Composite is a state-of-the-art light-curing, radiopaque, nano-hybrid composite for the restorative therapy. The device cures with light at the wavelength range of 400–500 nm (blue light). The device is paste contained in PP syringe.
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
All the groups
Intended User / Care Setting
Dental prosthetics and authorized laboratories and clinics
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
Non-clinical performance data was provided for the following test items: "Outward appearance-ISO 4049", "Sensitivity to ambient light-ISO 4049", "Depth of Cure-ISO 4049", "Flexural strength-ISO 4049", "Water sorption-ISO 4049", "solubility-ISO 4049", "Shade-ISO 4049", "Color comparison for color stability-ISO 4049", "Appearance of container-ISO 4049", "Delivery performance of container-ISO 4049", "Compressive Strength", "Elastic Modulus", "Surface Hardness", "particle size", and "Radio-opacity". All tests met the specified acceptance criteria. Biocompatibility testing met ISO 10993-1.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(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 includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 15, 2024
Sincera Technology (Changchun) Co., Ltd. % Eva Li Consultant Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave. Shanghai, China
Re: K240112
Trade/Device Name: Light Cure Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: January 16, 2024 Received: January 16, 2024
Dear Eva Li:
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.
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"
1
(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 OS 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).
Sincerely.
Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices
2
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240112
Device Name Light Cure Composite
Indications for Use (Describe) Anterior restorations (Class III, IV) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Restorations in the posterior region (Class I and II) Veneering of discolored anterior teeth Splinting of mobile teeth Repair of composite and ceramic veneers
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."
4
510(K) Summary
1. Information of the submitter:
Submitter's Name: Sincera Technology (Changchun) Co., Ltd. Address: No. 177 Changda Rd, Hi-tech District, Changchun City, Jilin Province, P. R. China Contact person: Tony Su
Tel: +8615143153582
Email: tony.su@sinceradental.com
Preparation Date: Jan 2nd, 2024
2. Basic information of the device
Classification Name: Material, Tooth Shade, Resin Common / Usual Name: Tooth shade resin material. Proprietary Name: Light Cure Composite Product Code: EBF Class: Class II Regulation: 21 CFR 872.3690
3. Predicate Device
K042819 TETRIC EVOCERAM VOCLAR VIVADENT, INC.
4. Indication for Use
Anterior restorations (Class III, IV) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Restorations in the posterior region (Class I and II) Veneering of discolored anterior teeth Splinting of mobile teeth Repair of composite and ceramic veneers
5. Device Description
Light Cure Composite is a state-of-the-art light-curing, radiopaque, nano-hybrid composite for the restorative therapy. The device cures with light at the wavelength range of 400–500 nm (blue light). The device is paste contained in PP syringe.
| Item | Subject device | Predicated device | Comparison |
|---|---|---|---|
| Device Name | Light Cure Composite | TETRIC VOCERAM | N/A |
| 510(K) No. | K042819 | N/A | |
| Classification | Class II | Class II | Same |
| Regulation | 21 CFR 872.3690 | 21 CFR 872.3690 | Same |
| Indication for use | Anterior restorations | Anterior restorations (Class) | Same |
| No. 177 Changda Rd, Hi-tech District, Changchun City, Jilin Province, P. R. China | |||
| (Class III, IV) | |||
| Class V restorations | |||
| (cervical caries, root | |||
| erosion, wedge-shaped | |||
| defects) | |||
| Restorations in the | |||
| posterior region (Class I | |||
| and II) | |||
| Veneering of discolored | |||
| anterior teeth | |||
| Splinting of mobile teeth | |||
| Repair of composite and | |||
| ceramic veneers | (Class III, IV) | ||
| Class V restorations | |||
| (cervical caries, root | |||
| erosion, wedge-shaped | |||
| defects) | |||
| Restorations in the | |||
| posterior region (Class I | |||
| and II) | |||
| Veneering of discolored | |||
| anterior teeth | |||
| Splinting of mobile teeth | |||
| Repair of composite and | |||
| ceramic veneers | |||
| Product Code | EBF | EBF | Same |
| Patient Population | All the groups | All the groups | Same |
| Prescription Use | Rx only | Rx only | Same |
| Environment | Dental prosthetics and | ||
| authorized laboratories | |||
| and clinics | Dental prosthetics and | ||
| authorized laboratories | |||
| and clinics | Same | ||
| Applicable Standards | ISO 4049; ISO 10993-1 | ISO 4049; ISO 10993-1 | Same |
| Device Sterilization | No | No | Same |
| Shelf life | 2 years | 3 years | Different*1 |
| Light curing unit | Power: ≥ 400mW/cm2 | ||
| Wavelength: 400-500nm | |||
| Curing time:20s | Power: ≥500mW/cm2 | ||
| Wavelength: 400-500nm | |||
| Curing time:20s | Different*2 | ||
| particle size | 0.4-2μm | 0.4-3μm | Different*3 |
| Elastic Modulus(GPa) | Mean:8.5 | Mean:7.4 | Different*3 |
| Compressive | |||
| Strength(MPa) | Mean:286.5 | Mean:248.4 | Different*3 |
| Surface | Mean:63.1 | Mean:53.8 | Different*3 |
| Hardness(HV) | |||
| Radio-opacity | Mean:2.27mm | Not provided | N/A |
6. Technological Characteristics Comparison:
5
7. Non-clinical performance Data:
| Test Item | Acceptance criterial | Result |
|---|---|---|
| Outward appearance-ISO 4049 | According to visual 1nspect1on, the product should be uniform in texture and should be a paste without visible impurities and foreign matter. | Meet the requirement |
| Sensitivity to ambient light-ISO 4049 | The material of sample remains physically homogeneous. | Meet the requirement |
| Depth of Cure-ISO 4049 | ≥1.5mm | ≥1.5mm |
| Flexural strength-ISO 4049 | ≥80Mpa | ≥80Mpa |
| Water sorption-ISO 4049 | ≤40µg/mm³ | ≤40µg/mm³ |
| solubility-ISO 4049 | ≤7.5µg/mm³ | ≤7.5µg/mm³ |
6
Sincera Technology (Changchun) Co., Ltd. No. 177 Changda Rd, Hi-tech District, Changchun City, Jilin Province, P. R. China
| Shade-ISO 4049 | Without the need for a magnifying glass to observe with the naked eye, the cured material should be evently coloredk | Meet the requirement |
|---|---|---|
| Color comparison for color stability-ISO 4049 | Only slight changes are allowed | Meet the requirement |
| Appearance of container-ISO 4049 | Visually observe that the surface of the container should be smooth, without scratches, cracks, burrs, small notches or macroscopic defects caused by mechanical processing. | Meet the requirement |
| Delivery performance of container-ISO 4049 | Remove the syringe cap and turn the container push rod clockwise allowing resin to be smoothly squeezed out of the syringe without obstruction | Meet the requirement |
| Compressive Strength | $\ge$ 200 Mpa | Meet the requirement |
| Elastic Modulus | $\ge$ 6 Gpa | Meet the requirement |
| Surface Hardness | $\ge$ 60(HV) | Meet the requirement |
| particle size | 0.4-2μm | |
| Radio-opacity | Mean: 2.27mm |
8. Biocompatibility
Meet ISO 10993-1 - Biological evaluation of medical devices — Part 1: Evaluation and testing.
9. Conclusion
The results of the testing described above provide reasonable assurance that the subject device is as safe and effective as the predicate device(s) which cleared under K042819 and supports a determination of substantial equivalence.