(99 days)
Not Found
No
The device description focuses on the chemical composition and physical properties of a dental composite material, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a restorative material for dental use, specifically a flowable composite for fillings and repairs, which does not inherently qualify it as a therapeutic device.
No
This device is a dental composite used for restorations and sealants, which are treatments, not diagnostic procedures.
No
The device description clearly states it is a "methacrylate based, low viscosity, visible-light activated, radiopaque, flowable composite" and contains "methacrylate resins, photo-initiator, and inorganic filler material." This describes 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 uses listed are all related to the direct restoration and repair of tooth structure. This is a therapeutic and restorative function performed directly on the patient's tooth.
- Device Description: The description details a material that is applied to the tooth and then light-cured to form a hard composite. This is a physical material used for structural repair.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
- Anatomical Site: The anatomical site is the "Tooth structure," which is where the material is applied and functions.
- Performance Studies: The performance studies mentioned are related to biocompatibility and benchtop assessments of physical properties, not the analysis of biological samples.
In summary, the Nanova™ Flowable Dental Composite is a dental restorative material used directly on the tooth for structural purposes, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Class III and V restorations o
- 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 o
Product codes
EBF
Device Description
Nanova™ Flowable Dental Composite is a methacrylate based, low viscosity, visible-light activated, radiopaque, flowable composite. This device is available in syringe and ampule packaging. Nanova™ Flowable Dental Composite is available in a variety of tooth colored shades. Nanova™ Flowable Dental Composite contains methacrylate resins, photo-initiator, and inorganic filler material. Inorganic filler loading is approximately 60% by weight.
When irradiated by light, the methacrylate functionalities of the resins and surface-treated fillers undergo, in conjunction with the photo-initiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive.
Nanova™ Flowable Dental Composite formulation is based off of several FDA cleared commercially available flowable dental composites. The formulation was modified to improve physical properties, such as flexural strength, and handling properties. As a result of the reformulation, a biocompatibility assessment was developed for Nanova™ Flowable Dental Composite using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines, including ISO 10993 Parts 3, 5, 6, 10 and 11.
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
Non-clinical and biological testing was completed to assess its performance and biocompatibility to support substantial equivalence. The data provided in this 510(k) submission shows that the composition is biocompatible based on the biocompatibility assessment conducted based on ISO 10993 and benchtop assessment based on UCM071631, ADA specification 27, and ISO 4049.
List of Tests Completed on Nanova™ Flowable Composite:
Radiopacity Evaluation
Color Stability Test
Compressive Strength
Depth of Cure
Double Bond Conversion (Degree of Conversion)
Flexural Strength
Knoop Hardness
Microtensile Strength
Sensitivity to Ambient Light
Shelf Life Depth of Cure
Shelf Life Flexural Strength
Water Sorption and Solubility
Custom Acute Systemic Injection
ISO Agarose Overlay Using L-929 Mouse Fibroblast Cells (GLP)
ISO Intracutaneous Irritation Test (GLP-2 Extracts)
ISO Guinea Pig Maximization Sensitization Test (GLP-2 Extracts)
ISO MEM Elution Using L-929 Mouse Fibroblast Cells (GLP)
Clinical performance data was not included.
Key Metrics
Shrinkage Stress: Nanova less stress
Microtensile Strength: Nanova Stronger
Water Sorption: Nanova Less absorption
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of a human figure, represented by three overlapping profiles facing to the right. The profiles are stylized and appear to be connected, creating a sense of unity and collaboration.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 18, 2015
Nanova Biomaterials, Inc. Mr. Andrew Ritts Senior Research Scientist 3806 Mojave Ct Columbia, Missouri 65202
Re: K150623
Trade/Device Name: Nanova Flowable Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: II Product Code: EBF Dated: May 6, 2015 Received: May 12, 2015
Dear Mr. Ritts:
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.
1
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,
Tina
Kiang -S
for 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
2
Image /page/2/Picture/0 description: The image shows the word "NANOVA" in blue font. The letters are bold and slightly blurred. The "O" in the word is stylized with a square shape in the center.
Nanova Biomaterials, Inc. Nanova™ Flowable Dental Composite Dental Composite 510(k) Notification
Section 4. Indications for Use Statement
(As Required by 21 CFR 807.87(e))
510(k) Number (if known): K150623
Device Name: Nanova™ Flowable Dental Composite
Indications for Use:
- Class III and V restorations o
- 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 o
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(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)
3
Image /page/3/Picture/0 description: The image shows the word "NANOVA" in blue font. The letters are all capitalized and sans-serif. The background is white. The image is slightly blurry.
Section 5. 510(k) Summary
-
- Submitted By: Nanova Biomaterials, Inc 3806 Mojave Ct Columbia, MO 65202 USA 573-875-6682
| Contact Person: | Andrew Ritts | Phone: (573) 823-3114 |
|---|---|---|
| Secondary Contact: | Liang Chen | Phone: (573) 239-8952 |
| 2) | Establishment Registration No.: | NA |
| 3) | Date Prepared: | March 5, 2015 |
| 4) | Device Trade Name: | Nanova™ Flowable Dental Composite |
| 5) | Device Common Name: | Flowable Dental Composite |
| 6) | Device Classification Name: | Material, Tooth Shade, Resin |
| 7) | Classification Panel: | Dental |
| 8) | Device Class: | Class II |
-
- Predicated Devices: Nanova™ Flowable Dental Composite is believed to be substantially equivalent to the following marketed products: Filtek Supreme Ultra Flowable Restorative (K100235) product code EBF manufactured by 3M ESPE.
10) Indication for Use:
- 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 ●
4
Section 5. 510(k) Summary - Cont.
-
- Device Description:
Nanova™ Flowable Dental Composite is a methacrylate based, low viscosity, visible-light activated, radiopaque, flowable composite. This device is available in syringe and ampule packaging. Nanova™ Flowable Dental Composite is available in a variety of tooth colored shades. Nanova™ Flowable Dental Composite contains methacrylate resins, photo-initiator, and inorganic filler material. Inorganic filler loading is approximately 60% by weight.
- Device Description:
When irradiated by light, the methacrylate functionalities of the resins and surface-treated fillers undergo, in conjunction with the photo-initiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive.
Nanova™ Flowable Dental Composite formulation is based off of several FDA cleared commercially available flowable dental composites. The formulation was modified to improve physical properties, such as flexural strength, and handling properties. As a result of the reformulation, a biocompatibility assessment was developed for Nanova™ Flowable Dental Composite using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines, including ISO 10993 Parts 3, 5, 6, 10 and 11.
-
- Substantial Equivalence:
The document, "Guidance on the CDRH Premarket Notification Review Program, 6/30/86 (K86-3)" was used to determine substantial equivalence:
- Substantial Equivalence:
a) The applicant device has the same intended use as the 510(k) cleared predicate listed above.
b) The technological characteristics of this product are believed to be substantially equivalent as those for the predicate device and other methacrylate based products currently on the market. Table 5.1 below shows a comparison of Nanova™ Flowable Composite and the predicate.
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Image /page/5/Picture/0 description: The image shows the word "NANOVA" in blue font. The letters are bold and sans-serif. The word is horizontally oriented and centered.
Section 5. 510(k) Summary - Cont.
| Table 5.1. Technical Comparison of Nanova™ Flowable Dental Composite and Filtek | ||
|---|---|---|
| Supreme Ultra Flowable Restorative (K100235). |
| Name | Nanova™ Flowable Dental
Composite | Filtek Supreme Ultra Flowable
Restorative (K100235) | Comparison |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Indications for
use | 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 | 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 | Same |
| Composition | Methacrylate resins, photo-
initiators, inorganic fillers | Methacrylate resins, photo-
initiators, inorganic fillers | Same |
| Flexural
Strength | ISO 4049:2009 (E) | ISO 4049:2009 (E) | Same |
| Polymerization
Method | Halogen and LED for 20s
with minimum intensity 400
mW/cm² in the 400-500 nm
range | Halogen and LED for 20s with
minimum intensity 400
mW/cm² in the 400-500 nm
range | Same |
| Compressive
Strength | ADA specification 27 | ADA specification 27 | Same |
| Shrinkage
Stress | Indiana University School of
Dentistry | Indiana University School of
Dentistry | Nanova less
stress |
| Depth of Cure | ISO 4049: 2009 (E) | ISO 4049: 2009 (E) | Both Pass |
| Microtensile
Strength | Internal Testing | Internal Testing | Nanova
Stronger |
| Water Sorption | ISO 4049:2009 (E) | ISO 4049:2009 (E) | Nanova Less
absorption |
| Water
Solubility | ISO 4049:2009 (E) | ISO 4049:2009 (E) | Same |
| Packaging | Syringe and Ampule | Syringe and Ampule | Same |
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Image /page/6/Picture/0 description: The image shows the word "NANOVA" in a sans-serif font. The word is written in blue. The letters are slightly blurred, giving the image a soft focus.
Section 5. 510(k) Summary - Cont.
-
- Non-Clinical Performance Testing:
Non-clinical and biological testing was completed to assess its performance and biocompatibility to support substantial equivalence. The data provided in this 510(k) submission shows that the composition is biocompatible based on the biocompatibility assessment conducted based on ISO 10993 and benchtop assessment based on UCM071631, ADA specification 27, and ISO 4049.
- Non-Clinical Performance Testing:
| Table 5.2 List of Tests Completed on Nanova™ Flowable Composite | |||
|---|---|---|---|
| -- | -- | ----------------------------------------------------------------- | -- |
| Name |
|---|
| Radiopacity Evaluation |
| Color Stability Test |
| Compressive Strength |
| Depth of Cure |
| Double Bond Conversion (Degree of Conversion) |
| Flexural Strength |
| Knoop Hardness |
| Microtensile Strength |
| Sensitivity to Ambient Light |
| Shelf Life Depth of Cure |
| Shelf Life Flexural Strength |
| Water Sorption and Solubility |
| Custom Acute Systemic Injection |
| ISO Agarose Overlay Using L-929 Mouse Fibroblast Cells (GLP) |
| ISO Intracutaneous Irritation Test (GLP-2 Extracts) |
| ISO Guinea Pig Maximization Sensitization Test (GLP-2 Extracts) |
| ISO MEM Elution Using L-929 Mouse Fibroblast Cells (GLP) |
-
- Clinical Performance Testing: Clinical performance data was not included.
Conclusion:
Nanova Biomaterials Inc. believes that Nanoval™ Flowable Dental Composite is substantially equivalent to currently legally marketed products. It does not introduce new indications for use, has similar technological characteristics and does not introduce new potential hazards or safety risks.