(115 days)
- Base under Class I and II direct restorations
- Liner under direct restorative materials
- Class III and V restorations
- Undercut Blockout
- Minimally invasive cavities (including small non stress-bearing occlusal restorations)
- Tunnel preparations
- Repair of small enamel defects
- Repair of small defects in esthetic indirect restorations
- Repair of resin and acrylic temporary materials
The new Bulk Fill Flowable Composite manufactured by Septodont Louisville is a low viscosity, radiopaque flowable composite which sets upon exposure to a high-intensity blue light source. After polymerization, it exhibits low stress on the bond with the tooth, and it has a high polymerization conversion. This high degree of polymerization is achieved with short curing times and creates improved physical and mechanical properties. The new Bulk Fill Flowable Composite is packaged in single dose capsules and syringes. The shades offered with Bulk Fill Flowable Composite are: A1, A2, A3, A3.5.
The provided text is a 510(k) summary for a dental device, "Bulk Fill Flowable Composite." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and performance data from bench tests. It is not a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details) because this document does not describe such a study for an AI/ML device.
Instead, the document focuses on:
- Bench testing: Physical tests conducted according to ISO 4049:2009 for properties like Depth of Cure, Conversion, Compressive Strength, Diametral Tensile Strength, Microhardness, Volume Shrinkage Stress, Water Absorption, and Solubility.
- Biocompatibility testing: Following ISO 10993-1:2009 and ISO 7405:2008.
- Comparison to predicate devices: Demonstrating similar indications for use and technological characteristics.
Here's a summary of what information is available related to performance and testing, but it does not fit the requested format for an AI/ML device study:
1. Table of Acceptance Criteria and Reported Device Performance: This document does not provide a table of acceptance criteria or specific numerical performance results for the listed physical tests. It only states that the device "was tested following" the ISO standards and that the data "evaluate the performance... in comparison with its predicates." The conclusion is that the device is "substantially equivalent" and "biocompatible and safe for its intended use."
2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML device test set. The document refers to "bench testing" of the "Bulk Fill Flowable Composite" itself. No specific sample sizes for these bench tests are mentioned, nor is data provenance in the sense of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML performance evaluation (e.g., expert labels on images) is not relevant to this bench testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental material, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the physical properties, the "ground truth" would be the standard scientific measurements themselves as defined by the ISO 4049:2009 standard. For biocompatibility, it would be the results against the criteria in ISO 10993-1:2009 and ISO 7405:2008.
8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires training data.
9. How the ground truth for the training set was established: Not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 14,2014
Septodent-Louisville Cora Bracho- Troconis Director of Secintific and Regulatory Affairs 416 S. Taylor Avenue Louisville, Co 80027
Re: K141994
Trade/Device Name: Bulk Fill Flowable Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin materal Regulatory Class: II Product Code: EBF Dated: August 15, 2014 Received: August 19, 2014
Dear Ms. Bracho-Troconis:
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. 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.
Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a symbol of three stylized human profiles facing to the right, overlapping each other.
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, mA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 004: Indications for Use Statement
(As Required by 21 CFR § 807.87)
510(k) Number: K141994
Device Name: Bulk Fill Flowable Composite
Indications for Use:
- Base under Class I and II direct restorations
- Liner under direct restorative materials
- Class III and V restorations
- Undercut Blockout
- Minimally invasive cavities (including small non stress-bearing occlusal restorations)
- Tunnel preparations
- Repair of small enamel defects
- Repair of small defects in esthetic indirect restorations
- Repair of resin and acrylic temporary materials
Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) 10
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Section 005: 510(k) Summary
(As Required By 21 CFR 807.92)
| 510(k) Applicant: | Septodont, Inc.416 S. Taylor AveLouisville, Co. 80027(303) 655-7535 |
|---|---|
| Contact Person: | Cora Bracho-TroconisDirector of Scientific and Regulatory AffairsPhone: (303) – 665-7535Fax: (303) – 666-4320cbracho@septodont.com |
| Date Summary was Prepared: | July 14th, 2014 |
| Trade Name: | Bulk Fill Flowable Composite |
| Common Name: | Bulk Fill Flowable Composite |
| Classification Name: | Material, Tooth Shade, Resin |
Predicate Devices:
| 510(k)# | Product | Manufacturer |
|---|---|---|
| K091635 | Venus Diamond Flow | Heraeus Kulzer |
| K120453 | Filtek Bulk Fill FlowableRestorative | 3M ESPE |
| K123773 | X-Tra Base | VOCO (GmbH) |
Device Description:
The new Bulk Fill Flowable Composite manufactured by Septodont Louisville is a low viscosity, radiopaque flowable composite which sets upon exposure to a high-intensity blue light source. After polymerization, it exhibits low stress on the bond with the tooth, and it has a high polymerization conversion. This high degree of polymerization is achieved with short curing times and creates improved physical and mechanical properties.
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The new Bulk Fill Flowable Composite is packaged in single dose capsules and syringes. The shades offered with Bulk Fill Flowable Composite are:
· A1, A2, A3, A3.5
Indications for Use:
- Base under Class I and II direct restorations
- Liner under direct restorative materials
- Class III and V restorations
- Undercut Blockout
- Minimally invasive cavities (including small non stress-bearing occlusal restorations)
- Tunnel preparations
- Repair of small enamel defects
- Repair of small defects in esthetic indirect restorations
- Repair of resin and acrylic temporary materials
Technological Characteristics
The new Bulk Fill Flowable Composite resin system consists of 3 major components. The resin system was designed using our crosslinkable proprietary monomer DDCDMA (Dimer Dicarbamate Dimethacrylate). A system has been designed using DDCDMA where EBPADMA (Ethoxylated Bisphenol "A" Dimethacrylate) is the base resin and UDMA (Urethacrylate) is added as a minor component. This is similar to the resin system used in N'Durance, a Septodont Universal composite cleared by the FDA K072150.
This 3-component resin polymerizes using a modified initiating system The chemistry of this resin system results in low stress on the bond with the tooth and high conversion of monomers into polymers. Additionally, these resins impart a greater hydrophobicity and are less sensitive to changes in atmospheric moisture.
The filler system in the new Bulk Fill Flowable Composite contains Ytterbium Fluoride mono dispersed nano sized particles for dental application. Silica, as well as an acid resistant silanated Barium glass.
When irradiated by light, the methacrylate functionalities of the resins and fillers undergo, in conjunction with the photoinitiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive.
Substantial Equivalence:
Biocompatibility:
Bulk-Fill Flowable composite was tested following ISO 10993-1:2009 and ISO 7405:2008. The conclusion of the assessment is that the product is biocompatible and safe for its intended use.
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Summary of Physical Tests
This 510(k) submission includes data from bench testing to evaluate the performance of Bulk Fill Flowable Composite in comparison with its predicates. The standard utilized was ISO 4049:2009. The properties that were tested include Depth of Cure, Conversion, Compressive Strength, Diametral Tensile Strength, Microhardness, Volume Shrinkage Stress, Water Absorption and Solubility.
Indications
Bulk Fill Flowable Composite has very similar indications as the claimed predicate devices Venus Diamond Flowable Composite (K091635), Filtek Bulk Fill (K120453) and X-Tra Base VOCO (K123773). Specifically, Bulk Fill Flowable Composite and Filtek Bulk Fill (K120453) are very similar in their indications, with the main difference being that Filtek Bulk Fill also includes Pit and Fissure and Core build-up indications.
Technology
The delivery and curing methods for the predicate devices are similar to that of Bulk Fill Flowable composite as well. They are all flowable composites which are applied directly to the site from a syringe or single unit dose tips. Additionally, all of these devices polymerize when irradiated by light to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive.
Conclusion:
Information provided in this 510(k) submission shows that Bulk Fill Flowable Composite is substantially equivalent to the identified predicate devices in terms of intended use, indications for use, physical properties and technological characteristics. In addition to being substantially equivalent, the Bulk Fill Flowable Composite has also been determined to be biocompatible and safe for its intended use.
§ 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.