(90 days)
Not Found
No
The 510(k) summary describes a dental composite material and its performance testing based on ISO standards, with no mention of AI or ML technology.
No
The device is a dental composite used for restorations, which is a structural material rather than a therapeutic agent for treating disease or injury.
No
Explanation: The device is described as a "light-cured, radiopaque, universal composite" used for "restorations," "core build-ups," and "splinting." These are explicit therapeutic and restorative uses, not diagnostic ones. Performance studies also focus on material properties like "flexural strength," "water solubility," and "radiopacity," which are relevant to a restorative material's effectiveness, not its ability to diagnose conditions.
No
The device description clearly states it is a "light-cured, radiopaque, universal composite," which is a physical material, not software. The performance studies also focus on material properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are for direct and indirect dental restorations, core build-ups, and splinting. These are procedures performed directly on or in the patient's mouth.
- Device Description: The device is described as a light-cured, radiopaque, universal composite. This is a material used for filling cavities and restoring tooth structure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples. This device is used inside the body as a restorative material.
N/A
Intended Use / Indications for Use
- Direct anterior and posterior restorations
- Core build ups
- Splinting
- Indirect restorations including inlays, onlays, and veneers
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
Quantium is a light-cured, radiopaque, universal composite. Quantium is designed to blend with the tooth structure when used alone or in the layering technique.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth structure
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)
Nonclinical testing of Quantium and the predicate device was selected from the FDA Guidance Document, Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff, issued October 2005. Sensitivity to light, depth of cure, flexural strength, water solubility, shade/color stability, and radiopacity were tested according to ISO 4049:2019. Additionally, compressive strength, flexural modulus, and hardness after cure were also tested.
Clinical testing is Not Applicable.
The nonclinical tests performed on Quantium and the predicate device showed Quantium performed equal to or better than the predicate. In addition, both devices meet the requirements set forth in ISO 4049:2019. These results demonstrate that Quantium is as safe, as effective, and performs as well as the predicate.
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
§ 872.3690 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 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.
December 17, 2024
Bisco. Inc. Jessica Berstein Global Regulatory Affairs Manager 1100 West Irving Park Road Schaumburg, Illinois 60193
Re: K242816
Trade/Device Name: Quantium Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: September 12, 2024 Received: September 18, 2024
Dear Jessica Berstein:
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
2
assistance/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, 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) | K242816 |
|---|---|
| Device Name | Quantum |
| Indications for Use (Describe) | Direct anterior and posterior restorationsCore build upsSplintingIndirect restorations including inlays, onlays, and veneers |
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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510(k) #: K242816
510(k) Summary
Prepared on: 2024-09-18
Contact D
21 CFR 807.92(a)(1)
| Applicant Name | Bisco, Inc. |
|---|---|
| Applicant Address | 1100 West Irving Park Road Schaumburg IL 60193 United States |
| Applicant Contact Telephone | 847-534-6034 |
| Applicant Contact | Ms. Jessica Bernstein |
| Applicant Contact Email | jbernstein@bisco.com |
21 CFR 807.92(a)(2)
| Device Trade Name | Quantium |
|---|---|
| Common Name | Tooth shade resin material |
| Classification Name | Material, Tooth Shade, Resin |
| Regulation Number | 872.3690 |
| Product Code(s) | EBF |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K202063 | TrusFIL Universal Composite Restorative | EBF |
Device Description Summary
21 CFR 807.92(a)(4)
Quantium is a light-cured, radiopaque, universal composite. Quantium is designed to blend with the tooth structure when used alone or in the layering technique.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
• Direct anterior and posterior restorations
• Core build ups
• Splinting
• Indirect restorations including inlays, onlays, and veneers
Indications for Use Comparison
21 CFR 807.92(a)(5)
The indications for use are similar. The additional text in the first indication of the predicate does not change the intended use; both the devices are indicated for direct anterior and posterior restorations.
Technological Comparison
21 CFR 807.92(a)(6)
Both Quantium and the predicate TrusFIL are methacrylate-based, radiopaque, light-cure pastes. Both also require the use of a dentalBoth Quantium and the predicate TrusFIL are methacrylate-based, radiopaque, light-cure pastes. Both also require the use of a dental adhesive and are available in a syringe and unit-dose capsule. The chemical composition of TrusFIL. All components of Quantium are based upon industry The difference in filler is Quantium's use of Ytterbium Fluoride, an industry standard filler, and is substantially equivalent in performance to TrusFIL's fillers.
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Nonclinical testing of Quantium and the predicate device was selected from the FDA Guidance Document, Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff, issued October 2005. Sensitivity to light, depth of cure, flexural strength, water solubility, shade/color stability, and radiopacity were tested according to ISO 4049:2019. Additionally, compressive strength, flexural modulus, and hardness after cure were also tested.
Clinical testing is Not Applicable.
The nonclinical tests performed on Quantium and the predicate device showed Quantium performed equal to or better than the predicate. In addition, both devices meet the requirements set forth in ISO 4049:2019. These results demonstrate that Quantium is as safe, as effective, and performs as well as the predicate.