(287 days)
No
The device description and performance studies focus on the material composition and physical properties of a dental composite, with no mention of AI or ML.
No
This device is a dental composite used for restorations and fillings, which are not considered therapeutic interventions in the medical sense. It is a material used to repair and restore tooth structure.
No
The device is a flowable composite material used for restorative dental procedures, such as filling cavities and as a base/liner, rather than for diagnosing conditions. Its intended use focuses on treatment and repair.
No
The device description clearly states it is a "low viscosity, visible light activated, radiopaque, flowable composite" and details its chemical composition and physical form (syringes and capsules). This describes a physical material, not software.
Based on the provided information, the Novidia™ Flowable Composite is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended uses listed are for dental restorations and related procedures performed directly on a patient's teeth. This is a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The description details the composition of a dental filling material.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on biocompatibility, mechanical properties (like resistance to microbial degradation), and surface integrity, which are relevant to a dental restorative material, not a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. The Novidia™ Flowable Composite is a material used on the body for treatment and restoration.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
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).
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)
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".
Biocompatibility tests included: Cytotoxicity, Oral Mucosal Irritation Test, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Bacterial Reverse Mutation, Mouse Lymphoma Assay, Biological Risk Assessment.
Bench testing included: 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.
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 data was not included.
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.
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 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
1
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
2
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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3
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.
4
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 Flowable
Restorative |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K100235 |
| Classification | EBF | EBF |
| Indications | • 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 sealant
• Blocking out of undercuts
• Repair of resin and acrylic
temporary materials | • Class III and V restorations
• Restoration of minimally invasive
cavity preparations (including
small, non-stress- bearing occlusal
restorations)
• Base/liner under direct
restorations
• Repair of small defects in esthetic
indirect restorations
• Pit and fissure sealant
• Undercut blockout
• Repair of resin and acrylic
temporary 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 |
| Flexural
Strength | ISO 4049:2009 | ISO 4049:2009 |
| Intensity for curing | ≥550 mW/cm2 | 400 -1000 mW/cm2 |
| Wavelength for
curing | 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 |
| Water
Solubility | ISO 4049:2009 | ISO 4049:2009 |
| Spontaneous
Polymerization
Sensitivity at
Ambient 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.
7
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.