(287 days)
The Novidia™ Flowable Composite is indicated for:
- Class III and V restorations
- Restoration of minimally invasive cavity preparations (including small, non-stress bearing occlusal restorations)
- As base/liner under direct or indirect restorations
- Repair of small defects in esthetic indirect restorations
- Pit and fissure sealing
- Blocking out of undercuts
- Repair of resin and acrylic temporary materials
Novidia™ Flowable Composite is a low viscosity, visible light activated, radiopaque, flowable composite indicated for minimally invasive cavity preparations as well as various other indications. The resin matrix of the Novidia™ Flowable Composite contains Urethane dimethacrylate (UDMA), Bisphenol-a glycidyl dimethacrylate (Bis-GMA) and triethylene glycol dimethacrylate (TEGDMA). The inorganic filler of the Novidia™ Flowable Composite is a mix of particles of alumino-silicate-based glasses, silica dioxide and pigments. A small percentage of the silica-based filler particles are covalently bound to quaternary ammonium residues (OASi), added to maintain the integrity of the restoration. The Novidia™ Flowable Composite is provided in syringes (2 g) and in single-dose capsules (0.2 g) and is available in three shades (A1, A2 and A3).
The provided text describes a 510(k) submission for a dental device, the Novidia™ Flowable Composite. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study proving acceptance criteria for a new AI/medical image analysis device. Therefore, much of the requested information regarding acceptance criteria, study details, and AI-specific metrics is not available in the provided text.
However, I can extract and structure the available information regarding performance data, which in this case refers to non-clinical testing.
1. Table of acceptance criteria and the reported device performance:
The document outlines a series of non-clinical (bench) tests performed on the Novidia™ Flowable Composite. For several key physical properties, it states that the device was tested according to ISO 4049:2009 standards, which would implicitly define the acceptance criteria, as the statement of "performing as intended" implies meeting these standards. However, the specific numerical acceptance criteria (e.g., minimum flexural strength value) are not explicitly stated in the text, nor are the precise numerical results for the Novidia™ Flowable Composite.
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Implicitly Meets Standard) |
|---|---|
| Flexural Strength (ISO 4049:2009) | Tested and performs as intended |
| Elastic Modulus | Tested and performs as intended |
| Compression Strength | Tested and performs as intended |
| Shade and Color Stability | Tested and performs as intended |
| Polymerization Conversion Degree | Tested and performs as intended |
| Viscosity | Tested and performs as intended |
| Spontaneous Polymerization Sensitivity (Ambient Light) (ISO 4049:2009) | Tested and performs as intended |
| Water Solubility (ISO 4049:2009) | Tested and performs as intended |
| Water Sorption (ISO 4049:2009) | Tested and performs as intended |
| Depth of Cure (ISO 4049:2009) | Tested and performs as intended |
| Radio-opacity (ISO 4049:2009) | Tested and performs as intended |
| Knoop Hardness | Tested and performs as intended |
| Preservation of Surface Integrity (Resistant to microbial degradation) | Novidia Flowable Composite with 1.2% (wt/wt) QASi filler is resistant to microbial degradation evidenced by preserved surface roughness in presence of continuous microbial challenge. |
Biocompatibility Testing:
| Biocompatibility Test (Standard Reference) | Reported Device Performance (Implicitly Meets Standard) |
|---|---|
| Cytotoxicity (ISO 10993 and ISO 7405) | Biocompatible |
| Oral Mucosal Irritation Test (ISO 10993 and ISO 7405) | Biocompatible |
| Acute Systemic Toxicity (ISO 10993 and ISO 7405) | Biocompatible |
| Material Mediated Pyrogenicity (ISO 10993 and ISO 7405) | Biocompatible |
| Bacterial Reverse Mutation (ISO 10993 and ISO 7405) | Biocompatible |
| Mouse Lymphoma Assay (ISO 10993 and ISO 7405) | Biocompatible |
| Biological Risk Assessment (ISO 10993 and ISO 7405) | Biocompatible |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any of the bench tests.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given these are bench tests rather than clinical studies, these terms are less applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided. The data comes from physical/chemical bench testing, not expert interpretation of medical images or conditions.
4. Adjudication method for the test set:
- This information is not applicable and not provided. Adjudication is relevant for clinical or image-based studies where multiple readers interpret data.
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:
- This information is not applicable and not provided. The device is a dental material, not an AI or medical image analysis device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable and not provided. The device is a dental material, not an AI or algorithm.
7. The type of ground truth used:
- The "ground truth" for the non-clinical performance and biocompatibility data is established by objective measurements and standardized protocols (e.g., ISO 4049, ISO 10993, ISO 7405 benchmarks for material properties and biological responses). For the "Preservation of Surface Integrity" test, the ground truth was the measured surface roughness under microbial challenge.
8. The sample size for the training set:
- This information is not applicable and not provided. This is a material science submission, not an AI/machine learning submission, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
- This information is not applicable and not provided, as there is no training set mentioned or implied.
In summary, the provided document describes the substantial equivalence of a dental material based on its physical, chemical, and biological properties evaluated through non-clinical bench testing. It does not contain information relevant to AI/medical image analysis device evaluation criteria such as clinical study design, expert consensus, or reader performance metrics.
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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 3, 2019
Nobio Ltd. % Shoshanna Friedman CEO ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, North Carolina 28269
Re: K182580
Trade/Device Name: Novidia Flowable Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: June 3, 2019 Received: June 4, 2019
Dear Shoshanna Friedman:
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.
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
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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 medical devices and radiation-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,
Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental 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
510(k) Number (if known)
Device Name Novidia™ Flowable Composite
Indications for Use (Describe)
The Novidia™ Flowable Composite is indicated for:
-
Class III and V restorations
-
Restoration of minimally invasive cavity preparations (including small, non-stress bearing occlusal restorations)
-
As base/liner under direct or indirect restorations
-
- Repair of small defects in esthetic indirect restorations
-
- Pit and fissure sealing
-
- Blocking out of undercuts
-
- Repair of resin and acrylic temporary materials
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) SUMMARY [as required by section 807.92(c)] Novidia™ Flowable Composite 510(k) Number K182580
5.1 SUBMITTER
Applicant's Name:
Nobio Ltd. 8 Hamatechet St. POB 50502 Kadima, Israel 6092000 Phone: +972-3-9059966
Contact Person:
Shoshana (Shosh) Friedman Regulatory Affairs Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: 704-430-8695 s.friedman@promedoss.com
Date Prepared:
June 3, 2019
5.2 DEVICE
Trade Name: Novidia™ Flowable Composite
Classification: Name: Material, Tooth Shade, Resin Product Code: EBF Regulation No: 872.3690 Class: 2 Review Panel: Dental
5.3 PREDICATE DEVICE
Filtek™ Supreme Ultra Flowable Restorative, manufactured by 3M Company, cleared under K100235.
Additionally, we are using the following reference devices as examples of FDAcleared devices that incorporate quaternary ammonium in their formulation:
- Clearfil Protect Bond cleared under K033938
- . Orthodontic Acrylic cleared under K141439 and Orthodontic Acrylic 2 cleared under K163482.
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DEVICE DESCRIPTION 5.4
Novidia™ Flowable Composite is a low viscosity, visible light activated, radiopaque, flowable composite indicated for minimally invasive cavity preparations as well as various other indications.
The resin matrix of the Novidia™ Flowable Composite contains Urethane dimethacrylate (UDMA), Bisphenol-a glycidyl dimethacrylate (Bis-GMA) and triethylene glycol dimethacrylate (TEGDMA).
The inorganic filler of the Novidia™ Flowable Composite is a mix of particles of alumino-silicate-based glasses, silica dioxide and pigments. A small percentage of the silica-based filler particles are covalently bound to quaternary ammonium residues (OASi), added to maintain the integrity of the restoration.
Note: "Clinical studies demonstrating that the presence of OASi in this device improves clinical outcomes have not been conducted".
The Novidia™ Flowable Composite is provided in syringes (2 g) and in single-dose capsules (0.2 g) and is available in three shades (A1, A2 and A3).
ર્સ્ડ INDICATIONS FOR USE
Novidia™ Flowable Composite is indicated for use in:
-
- Class III and V restorations
-
- Restoration of minimally invasive cavity preparations (including small, nonstress-bearing occlusal restorations)
-
- As base/liner under direct or indirect restorations
-
- Repair of small defects in esthetic indirect restorations
-
- Pit and fissure sealant
-
- Blocking out of undercuts
-
- Repair of resin and acrylic temporary materials
5.6 SUBSTANTIAL EQUIVALENCE
The Novidia™ Flowable Composite has the same indications as the Filtek™ Supreme Ultra Flowable Restorative.
The technological characteristics of the Novidia™ Flowable Composite are substantially equivalent to these of the predicate device and other methacrylate-based products currently on the market. Table 5-1 below shows a comparison of Novidia™ Flowable Composite and the predicate device.
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| Feature | Novidia™ Flowable Composite | Filtek Supreme Ultra FlowableRestorative |
|---|---|---|
| 510(k) Number | K100235 | |
| Classification | EBF | EBF |
| Indications | • Class III and V restorations• Restoration of minimally invasivecavity preparations (includingsmall, non-stress-bearing occlusalrestorations)• As base/liner under direct orindirect restorations• Repair of small defects in estheticindirect restorations• Pit and fissure sealant• Blocking out of undercuts• Repair of resin and acrylictemporary materials | • Class III and V restorations• Restoration of minimally invasivecavity preparations (includingsmall, non-stress- bearing occlusalrestorations)• Base/liner under directrestorations• Repair of small defects in estheticindirect restorations• Pit and fissure sealant• Undercut blockout• Repair of resin and acrylictemporary materials |
| Composition | Methacrylate resins, photo-initiators, inorganic fillers | Methacrylate resins, photo-initiators, inorganic fillers |
| Packaging | Syringe and single-dose capsule | Syringe and single-dose capsule |
| FlexuralStrength | ISO 4049:2009 | ISO 4049:2009 |
| Intensity for curing | ≥550 mW/cm2 | 400 -1000 mW/cm2 |
| Wavelength forcuring | 430-490 nm | 400-500 nm |
| Curing time | 20 sec. | Opaque shades 40 sec;All other shades 20 sec. |
| Radio-opacity | ISO 4049: 2009 | ISO 4049: 2009 |
| Depth of Cure | ISO 4049: 2009 | ISO 4049: 2009 |
| Water Sorption | ISO 4049:2009 | ISO 4049:2009 |
| WaterSolubility | ISO 4049:2009 | ISO 4049:2009 |
| SpontaneousPolymerizationSensitivity atAmbient Light | ISO 4049:2009 | ISO 4049:2009 |
Table 5-1: Comparison of Novidia™ Flowable Composite and Filtek™ Supreme Ultra Flowable Restorative
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5.7 PERFORMANCE DATA
Non-Clinical Performance Testing:
Non-clinical and biological testing was completed to assess the performance and biocompatibility of the Novidia™ Flowable Composite and to support substantial equivalence. The data provided in this 510(k) submission shows that the composite is biocompatible based on the biocompatibility assessment conducted as per ISO 10993 and ISO 7405 and performs as intended based on the bench testing per ISO 4049 and FDA guidance document "Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions". The list of these tests is provided in Table 5-2.
| Biocompatibility |
|---|
| Cytotoxicity |
| Oral Mucosal Irritation Test |
| Acute Systemic Toxicity |
| Material Mediated Pyrogenicity |
| Bacterial Reverse Mutation |
| Mouse Lymphoma Assay |
| Biological Risk Assessment |
| Bench Testing |
| Flexural strength |
| Elastic modulus |
| Compression strength |
| Shade and color stability |
| Polymerization conversion degree |
| Viscosity |
| Spontaneous polymerization sensitivity at ambient light |
| Water solubility |
| Water sorption |
| Depth of cure |
| Radio-opacity |
| Knoop hardness |
Table 5-2: List of Tests Completed on Novidia™ Flowable Composite
An additional test that was performed is "Preservation of Surface Integrity". This study used the atomic force microscopy (AFM) method to test the hypothesis that incorporation of QASi into the Novidia Flowable Composite prevents the increase of surface roughness (a surrogate measure of material degradation) caused by biofilm. The study concluded that the Novidia Flowable Composite with 1.2% (wt/wt) QASi filler is resistant to microbial degradation evidenced by preserved surface roughness in presence of continuous microbial challenge and therefore supports the thesis that 1.2% QASi filler improves the integrity of the dental composite restorations and preserves its functionality over time. Clinical studies demonstrating that the addition of 1.2% wt/wt QASi results in enhanced clinical outcomes have not been conducted.
Animal and Clinical Performance Testing:
Animal and clinical performance data was not included.
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5.8 CONCLUSION
Nobio Ltd. believes that Novidia™ Flowable Composite is substantially equivalent to the Filtek™ Supreme Ultra Flowable Restorative and other legally marketed products. It does not introduce new indications for use, has similar technological characteristics and does not introduce any new safety or effectiveness concerns.
§ 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.