Novidia Bulk Fill Flow Composite

K182714 · Nobio , Ltd. · EBF · Jul 12, 2019 · Dental

Device Facts

• Record ID: K182714
• Device Name: Novidia Bulk Fill Flow Composite
• Applicant: Nobio , Ltd.
• Product Code: EBF · Dental
• Decision Date: Jul 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Novidia™ Bulk Fill Flow Composite is indicated for: 1. Base under Class I and II direct restorations 2. Liner under direct restorative materials 3. Pit and fissure sealant 4. Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations) 5. Class III and V restorations 6. Blocking out of undercuts 7. Repair of small enamel defects 8. Repair of small defects in esthetic indirect restorations 9. Repair of resin and acrylic temporary materials 10. As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown

Device Story

Novidia™ Bulk Fill Flow Composite is a low-viscosity, visible-light-activated, radiopaque flowable composite; used by dentists in clinical settings for restorative dentistry. Device consists of methacrylate resin matrix (UDMA, Bis-GMA, TEGDMA) and inorganic fillers (alumino-silicate glass, silica dioxide, pigments). A portion of silica filler is covalently bound to quaternary ammonium residues (QASi) to maintain restoration integrity. Supplied in syringes or single-dose capsules. Applied by clinician to tooth structure; cured using dental light (430-490 nm). Provides structural support, seals, or repairs tooth defects. Benefits include minimally invasive application and restoration of tooth function/esthetics.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing per ISO 4049 (flexural strength, depth of cure, radio-opacity, water sorption/solubility) and biocompatibility testing per ISO 10993/7405 (cytotoxicity, irritation, systemic toxicity, pyrogenicity, genotoxicity).

Technological Characteristics

Low-viscosity, light-cured composite. Materials: UDMA, Bis-GMA, TEGDMA resins; alumino-silicate glass, silica dioxide, and QASi-modified silica fillers. Curing: 430-490 nm wavelength, ≥550 mW/cm² intensity. Form factor: Syringe or single-dose capsule. Standards: ISO 4049 (performance), ISO 10993/7405 (biocompatibility).

Indications for Use

Indicated for dental patients requiring direct restorations, cavity liners, pit/fissure sealants, minimally invasive cavity preparations, Class III/V restorations, undercut block-outs, repair of enamel/indirect restoration/temporary material defects, and core build-ups.

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™ Bulk Fill Flowable Restorative (K120453)

Reference Devices

• Clearfil Protect Bond (K033938)
• Orthodontic Acrylic (K141439)
• Orthodontic Acrylic 2 (K163482)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 12, 2019

Nobio Ltd. % Shoshana Friedman Regulatory Consultant ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, North Carolina 28269

Re: K182714

Trade/Device Name: Novidia™ Bulk Fill Flow Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: June 11, 2019 Received: June 12, 2019

### Dear Shoshana 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.

{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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for 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)

K182714

Device Name

Novidia™ Bulk Fill Flow Composite

Indications for Use (Describe)

The Novidia™ Bulk Fill Flow Composite is indicated for:

- 1. Base under Class I and II direct restorations
- 2. Liner under direct restorative materials
- 3. Pit and fissure sealant
- 4. Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
- 5. Class III and V restorations
- 6. Blocking out of undercuts
- 7. Repair of small enamel defects
- 8. Repair of small defects in esthetic indirect restorations
- 9. Repair of resin and acrylic temporary materials

10. As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown

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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 510(K) SUMMARY [as required by section 807.92(c)] Novidia™ Bulk Fill Flow Composite 510(k) Number K182714

#### 5.1 SUBMITTER

### Applicant's Name:

Nobio Ltd. 8 Hamatechet St. POB 50502 Kadima, Israel 6092000 Phone: [phone]

### Contact Person:

Shoshana (Shosh) Friedman Regulatory Affairs Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: [phone] [e-mail]

Date Prepared:

July 12, 2019

#### 5.2 DEVICE

Trade Name: Novidia™ Bulk Fill Flow Composite

Classification: Name: Tooth Shade Resin Material Product Code: EBF Regulation No: 872.3690 Class: 2 Review Panel: Dental

#### 5.3 PREDICATE DEVICE

Filtek™ Bulk Fill Flowable Restorative, manufactured by 3M ESPE Dental Products, cleared under K120453 is the primary predicate device.

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 2cleared under K163482.

{4}------------------------------------------------

#### 5.4 DEVICE DESCRIPTION

Novidia™ Bulk Fill Flow 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™ Bulk Fill Flow Composite contains Urethane dimethacrylate (UDMA), Bisphenol-a glycidyl dimethacrylate (Bis-GMA) and triethylene glycol dimethacrylate (TEGDMA).

The inorganic filler of the Novidia™ Bulk Fill Flow 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 (QASi), added to maintain the integrity of the restoration.

Note: "Clinical studies demonstrating that the presence of QASi in this device improves clinical outcomes have not been conducted".

The Novidia™ Bulk Fill Flow Composite is provided in syringes (2 g) and in singledose capsules (0.2 g) and is available in two shades (A2 and A3).

#### ર્ડ INDICATIONS FOR USE

Novidia™ Bulk Fill Flow Composite is indicated for:

- 1. Base under Class I and II direct restorations
- 2. Liner under direct restorative materials
- 3. Pit and fissure sealant
- 4. Restoration of minimally invasive cavity preparations (including small, nonstress-bearing occlusal restorations)
- 5. Class III and V restorations
- 6. Blocking out of undercuts
- 7. Repair of small enamel defects
- 8. Repair of small defects in esthetic indirect restorations
- Repair of resin and acrylic temporary materials 9.
- 10. As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown

#### 5.6 SUBSTANTIAL EQUIVALENCE

The Novidia™ Bulk Fill Flow Composite has the same indications as the Filtek™ Bulk Fill Flowable Restorative.

The technological characteristics of the Novidia™ Bulk Fill Flow 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™ Bulk Fill Flow Composite and the predicate device.

{5}------------------------------------------------

| Feature | Novidia™ Bulk Fill Flow<br>Composite | Filtek Bulk Fill<br>Flowable<br>Restorative | Comparison |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K182714 | K120453 | NA |
| Classification | EBF | EBF | Same |
| Indications | • Base under Class I and II<br>direct restoration<br>• Liner under direct restorative<br>materials<br>• Pit and fissure sealant<br>• Restoration of minimally<br>invasive cavity preparations<br>(including small, non-stress-<br>bearing occlusal restorations)<br>• Class III and V restorations<br>• Blocking out of undercuts<br>• Repair of small enamel defects<br>• Repair of small defects in<br>esthetic indirect restorations<br>• Repair of resin and acrylic<br>temporary materials<br>• As a core build-up where at<br>least half the coronal tooth<br>structure is remaining to<br>provide structural support for<br>the crown | • Base under Class I and<br>II direct restorations<br>• Liner under direct<br>restorative materials<br>• Pit and fissure sealant<br>• Restoration of minimally<br>invasive cavity preparations<br>(including small, non-stress<br>bearing occlusal<br>restorations)<br>• Class III and V restorations<br>• Undercut blockout<br>• Repair of small enamel defects<br>• Repair of small defects in<br>esthetic indirect<br>restorations<br>• Repair of resin and<br>acrylic temporary<br>materials<br>• As a core build-up where at<br>least half the coronal tooth<br>structure is remaining to<br>provide structural support<br>for<br>the crown | Same |
| Composition | Methacrylate resins, photo-<br>initiators, inorganic fillers | Methacrylate resins,<br>photo- initiators, inorganic<br>fillers | Similar |
| Packaging | Syringe and single-dose capsule | Syringe and ampule | Same |
| Flexural<br>Strength | ISO 4049:2009 | ISO 4049:2009 | Both met<br>acceptance<br>criteria of ≥80<br>MPa |
| Intensity for<br>curing | $≥550 mW/cm²$ | $400 -1000 mW/cm²$ | Similar |
| Wavelength for<br>curing | 430-490 nm | 400-500 nm | Same |
| Curing time | 20 sec. | Opaque shades 40 sec;<br>All other shades 20 | Same |
| Radio-opacity | ISO 4049: 2009 | ISO 4049: 2009 | Both met<br>acceptance<br>criteria of >1.0<br>mm Al |
| Depth of Cure | ISO 4049: 2009 | ISO 4049: 2009 | Both met<br>acceptance<br>criteria of $\ge$ 2mm<br>at an intensity of<br>$\ge$ 550 mW/cm2 for<br>20 seconds |
| Water Sorption | ISO 4049:2009 | ISO 4049:2009 | Both met<br>acceptance<br>criteria of $\le$<br>40 $\mu$ g/mm3 |
| Water<br>Solubility | ISO 4049:2009 | ISO 4049:2009 | Both met<br>acceptance<br>criteria of $\le$ 7.5<br>$\mu$ g/mm3 |
| Spontaneous<br>Polymerization<br>Sensitivity at<br>Ambient Light | ISO 4049:2009 | ISO 4049:2009 | Both met<br>acceptance<br>criteria of 60 $\pm$ 5<br>sec. (physically<br>homogenous by<br>visual inspection) |

# Table 5-1: Comparison of Novidia™ Bulk Fill Flow Composite and Filtek™ Bulk Fill Flowable Restorative

{6}------------------------------------------------

{7}------------------------------------------------

#### 5.7 PERFORMANCE DATA

## Non=Clinical Performance Testing:

Non-clinical and biological testing was completed to assess the performance and biocompatibility of the Novidia™ Bulk Fill Flow 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.

Table 5-2: List of Tests Completed on Novidia™ Bulk Fill Flow Composite

| 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 | | |
| Preservation of Surface Integrity | | |

### Animal and Clinical Performance Testing:

Animal and clinical performance data was not included.

{8}------------------------------------------------

#### 5.8 CONCLUSION

Nobio Ltd. believes that Novidia™ Bulk Fill Flow Composite is substantially equivalent to the Filtek™ Bulk Fill Flow Restorative and other legally marketed products.