(120 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 the use of AI/ML.
No.
The device is a dental composite used for restorations, splinting, and core build-ups, which are structural and restorative functions rather than therapeutic ones.
No.
The device is a dental composite used for restoring teeth, not for diagnosing medical conditions.
No
The device description clearly states it is a methacrylate-based, visible-light activated, radiopaque, universal composite, which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that Nanova Universal Dental Composite is a material used for direct restorations, core build-ups, splinting, and indirect restorations on teeth. It is a physical material applied to the tooth structure.
- No Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device is used directly on the patient's teeth.
Therefore, based on the provided information, Nanova Universal Dental Composite is a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Nanova Universal Dental Composite is indicated for use in:
- · Direct anterior and posterior restorations (including occlusal surfaces)
- Core Build-ups
- · Splinting
- · Indirect restorations including inlays, onlays and veneers
Product codes
EBF
Device Description
Nanova™ Universal Dental Composite is a methacrylate based, visible-light activated, radiopaque, universal composite. This device is available in twist syringe and ampule packaging. Nanova™ Universal Dental Composite is available in a variety of tooth colored shades. Nanova"™ Universal Dental Composite contains methacrylate resins, photo-initiator, and inorganic filler material. Inorganic filler loading is approximately 77% 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™ Universal Dental Composite formulation is based off of several FDA approved commercially available universal 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™ Universal Dental Composite using standard risk assessment techniques and consideration of FDA & International Standards, including ISO 10993 Parts 5 and 10.
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 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. All biocompatibility tests completed were passed.
Results for individual tests:
Radiopacity Evaluation - Passed
Color Stability - Passed
Flexural Strength - Passed
Compressive Strength - Passed
Depth of Cure - Passed
Microtensile Strength - Passed
Water Sorption and Solubility - Passed
Knoop Hardness - Passed
Double Bond Conversion (Degree of Conversion) - Passed
ISO Agarose Overlay Using L-929 Mouse Fibroblast Cells - Passed
ISO Intracutaneous Irritation Test - Passed
ISO Guinea Pig Maximization Sensitization Test - Passed
ISO MEM Elution Using L-929 Mouse Fibroblast Cells - Passed
Shelf life - Passed
Surface Gloss - Passed
Surface Roughness - Passed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a human face in profile, with three overlapping profiles to represent the department's focus on health, human services, and the well-being of the nation. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2015
Nanova Biomaterials, Inc. Mr. Andrew Ritts Senior Research Scientist 3806 Mojave Ct Columbia, Missouri, 65202
Re: K152004
Trade/Device Name: Nanova™ Universal Dental Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: II Product Code: EBF Dated: October 12, 2015 Received: October 19, 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 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,
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
Nanova Biomaterials. Inc. Nanova™ Universal 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): K152004
Device Name: Nanova 204 Universal Dental Composite
Indications for Use:
Nanova Universal Dental Composite is indicated for use in:
- · Direct anterior and posterior restorations (including occlusal surfaces)
- Core Build-ups
- · Splinting
- · Indirect restorations including inlays, onlays and veneers
Prescription Use X X
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 F NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows the word "NANOVA" in blue, with each letter in a bold, sans-serif font. The letters are evenly spaced and aligned horizontally. The overall impression is clean and modern.
Nanova Biomaterials, Inc. Nanova™ Universal Dental Composite Dental Composite K152004
Section 5. 510(k) Summary
-
- Submitted By: Nanova Biomaterials, Inc 3806 Mojave Ct Columbia, MO 65202 USA 573-875-6682
| | Contact Person: Andrew Ritts
Secondary Contact: Liang Chen | Phone: (573) 823-3114
Phone: (573) 239-8952 |
|----|---------------------------------------------------------------|---------------------------------------------------------------------|
| 2) | Establishment Registration No.: | 3011430871 |
| 3) | Date Prepared: | October 12, 2015 |
| 4) | Device Trade Name: | Nanova™ Universal Dental Composite |
| 5) | Device Common Name: | Universal Dental Composite |
| 6) | Device Classification Name: | Material, Tooth Shade, Resin
Product code: EBF, Reg. #: 872.3690 |
| 7) | Classification Panel: | Dental |
| 8) | Device Class: | Class II |
-
- Predicate Devices: Nanova™ Universal Dental Composite is believed to be substantially equivalent to the following marketed products: Filtek Supreme Ultra Universal Restorative (K083610) product code EBF manufactured by 3M ESPE.
10) Indication for Use: Nanova Universal Dental Composite is indicated for use in:
- Direct anterior and posterior restorations (including occlusal surfaces)
- Core Build-ups
- Splinting ●
- . Indirect restorations including inlays, onlays and veneers
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Image /page/4/Picture/0 description: The image shows the word "NANOVA" in a sans-serif font. The word is written in a bright blue color. The letters are all capitalized and evenly spaced. The background is white.
Nanova Biomaterials, Inc. Nanova™ Universal Dental Composite Dental Composite K152004
Section 5. 510(k) Summary - Cont.
-
- Device Description:
Nanova™ Universal Dental Composite is a methacrylate based, visible-light activated, radiopaque, universal composite. This device is available in twist syringe and ampule packaging. Nanova™ Universal Dental Composite is available in a variety of tooth colored shades. Nanova"™ Universal Dental Composite contains methacrylate resins, photo-initiator, and inorganic filler material. Inorganic filler loading is approximately 77% 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™ Universal Dental Composite formulation is based off of several FDA approved commercially available universal 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™ Universal Dental Composite using standard risk assessment techniques and consideration of FDA & International Standards, including ISO 10993 Parts 5 and 10.
-
- 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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Section 5. 510(k) Summary - Cont.
Table 5.1 Technical Comparison of NanovaTM Universal Dental Composite and Filtek Supreme Ultra Universal Restorative (K083610)
| Name | Nanova™ Universal Dental Composite | Filtek Supreme Ultra Universal Restorative (K083610) | Comparison |
|---|---|---|---|
| Indications for use | Direct anterior and posterior restorations (including occlusal surfaces) | ||
| Core Build-ups | |||
| Splinting | |||
| Indirect restorations including inlays, onlays and veneers | Direct anterior and posterior restorations (including occlusal surfaces) | ||
| Core Build-ups | |||
| Splinting | |||
| Indirect restorations including inlays, onlays and veneers | Indicated for the same purposes | ||
| Composition | Methacrylate resins, photo-initiators, inorganic fillers | Methacrylate resins, photo-initiators, inorganic fillers | Chemistries are similar |
| Flexural Strength | ISO 4049:2009 (E) | ISO 4049:2009 (E) | Both above 100 MPa |
| Compressive Strength | ADA specification 27 | ADA specification 27 | Both above 300 MPa |
| Depth of Cure | Passes ISO 4049:2009(E) | Passes ISO 4049:2009(E) | Passed |
| Water Sorption | ISO 4049:2009 (E) | ISO 4049:2009 (E) | Nanova Less Adsorption |
| Water Solubility | ISO 4049:2009 (E) | ISO 4049:2009 (E) | Nanova Less Solubility |
| Packaging | Twist Syringe and Ampule | Twist Syringe and Ampule | Both use twist syringe and ampules |
Nanova™ Universal Dental Composite fulfilled ISO 4049 requirements as well as FDA 's guidance ucm071576 Dental Composite Resin Devices. The strength and physical properties show Nanova™ Universal Dental Composite performs equivalently to the predicate device. ISO 10993 biocompatibility (including cytotoxicity, irritation, and sensitization) confirms the material is biocompatible. The fulfillment of ISO 4049 and ISO 10993 show Nanova Universal Dental Composite is substantially equivalent to the predicate.
These differences do not affect the equivalence.
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Image /page/6/Picture/0 description: The image shows the word "NANOVA" in blue font. The letters are bold and slightly blurred. The background is white.
Nanova Biomaterials, Inc. Nanova™ Universal Dental Composite Dental Composite K152004
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. All biocompatibility tests completed were passed.
| Name | Result |
|---|---|
| Radiopacity Evaluation | Passed |
| Color Stability | Passed |
| Flexural Strength | Passed |
| Compressive Strength | Passed |
| Depth of Cure | Passed |
| Microtensile Strength | Passed |
| Water Sorption and Solubility | Passed |
| Knoop Hardness | Passed |
| Double Bond Conversion (Degree of Conversion) | Passed |
| ISO Agarose Overlay Using L-929 Mouse Fibroblast Cells | Passed |
| ISO Intracutaneous Irritation Test | Passed |
| ISO Guinea Pig Maximization Sensitization Test | Passed |
| ISO MEM Elution Using L-929 Mouse Fibroblast Cells | Passed |
| Shelf life | Passed |
| Surface Gloss | Passed |
| Surface Roughness | Passed |
Table 5.2 List of Tests Completed on Nanova™ Universal Composite
-
- Clinical Performance Testing: Clinical performance data was not included.
Conclusion:
Nanova Biomaterials Inc. believes that Nanova™ Universal 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 risks.