Nanova Flowable Composite

K150623 · Nanova Biomaterials, Inc. · EBF · Jun 18, 2015 · Dental

Device Facts

• Record ID: K150623
• Device Name: Nanova Flowable Composite
• Applicant: Nanova Biomaterials, Inc.
• Product Code: EBF · Dental
• Decision Date: Jun 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

Nanova Flowable Dental Composite is a methacrylate-based, low-viscosity, radiopaque, visible-light-activated restorative material. Used by dental professionals in clinical settings for various restorative procedures, including Class III and V restorations, cavity preparations, base/liner applications, and repairs of temporary materials. The device is supplied in syringes or ampules. Upon application, the material is irradiated with a halogen or LED light (400-500 nm range), triggering a photo-initiator system that polymerizes the methacrylate resins and inorganic fillers into a hard composite. This composite bonds to tooth structure via a permanent dental adhesive. The device provides a restorative solution for dental defects, offering improved physical properties such as flexural strength and handling compared to previous formulations. Clinical benefits include structural restoration and aesthetic repair of tooth surfaces.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including radiopacity, color stability, compressive strength (ADA 27), depth of cure (ISO 4049), degree of conversion, flexural strength (ISO 4049), Knoop hardness, microtensile strength, water sorption/solubility (ISO 4049), and biocompatibility testing (ISO 10993 parts 3, 5, 6, 10, 11).

Technological Characteristics

Methacrylate-based resin with ~60% inorganic filler loading. Visible-light activated (400-500 nm). Complies with ISO 4049:2009 and ADA specification 27. Form factor: syringe or ampule. Biocompatibility per ISO 10993.

Indications for Use

Indicated for Class III and V restorations, minimally invasive cavity preparations, base/liner under direct restorations, repair of small defects in esthetic indirect restorations, pit and fissure sealant, undercut blockout, and repair of resin and acrylic temporary materials.

Regulatory Classification

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.

Predicate Devices

• Filtek Supreme Ultra Flowable Restorative (K100235)

Submission Summary (Full Text)

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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.

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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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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 [phone] or [phone] 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

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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)

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#### Section 5. 510(k) Summary

- 1) Submitted By: Nanova Biomaterials, Inc 3806 Mojave Ct Columbia, MO 65202 USA 573-875-6682

| Contact Person: | Andrew Ritts | Phone: [phone] |
|--------------------|---------------------------------|-----------------------------------|
| Secondary Contact: | Liang Chen | Phone: [phone] |
| 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 |

- 9) 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 ●

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#### Section 5. 510(k) Summary - Cont.

- 11) 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.

- 12) Substantial Equivalence:
The document, "Guidance on the CDRH Premarket Notification Review Program, 6/30/86 (K86-3)" was used to determine 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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# 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<br>Composite | Filtek Supreme Ultra Flowable<br>Restorative (K100235) | Comparison |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Indications for<br>use | Class III and V restorations<br>Restoration of minimally<br>invasive cavity preparations<br>(including small, non stress-<br>bearing occlusal<br>restorations)<br>Base/liner under direct<br>restorations<br>Repair of small defects in<br>esthetic indirect restorations<br>Pit and fissure sealant<br>Undercut blockout<br>Repair of resin and acrylic<br>temporary materials | Class III and V restorations<br>Restoration of minimally<br>invasive cavity preparations<br>(including small, non stress-<br>bearing occlusal restorations)<br>Base/liner under direct<br>restorations<br>Repair of small defects in<br>esthetic indirect restorations<br>Pit and fissure sealant<br>Undercut blockout<br>Repair of resin and acrylic<br>temporary materials | Same |
| Composition | Methacrylate resins, photo-<br>initiators, inorganic fillers | Methacrylate resins, photo-<br>initiators, inorganic fillers | Same |
| Flexural<br>Strength | ISO 4049:2009 (E) | ISO 4049:2009 (E) | Same |
| Polymerization<br>Method | Halogen and LED for 20s<br>with minimum intensity 400<br>mW/cm² in the 400-500 nm<br>range | Halogen and LED for 20s with<br>minimum intensity 400<br>mW/cm² in the 400-500 nm<br>range | Same |
| Compressive<br>Strength | ADA specification 27 | ADA specification 27 | Same |
| Shrinkage<br>Stress | Indiana University School of<br>Dentistry | Indiana University School of<br>Dentistry | Nanova less<br>stress |
| Depth of Cure | ISO 4049: 2009 (E) | ISO 4049: 2009 (E) | Both Pass |
| Microtensile<br>Strength | Internal Testing | Internal Testing | Nanova<br>Stronger |
| Water Sorption | ISO 4049:2009 (E) | ISO 4049:2009 (E) | Nanova Less<br>absorption |
| Water<br>Solubility | ISO 4049:2009 (E) | ISO 4049:2009 (E) | Same |
| Packaging | Syringe and Ampule | Syringe and Ampule | Same |

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## Section 5. 510(k) Summary - Cont.

- 13) 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.

| | | 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) |

- 14) 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.