R&D Series Nova Compo N

K192178 · Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · EBF · Dec 20, 2019 · Dental

Device Facts

• Record ID: K192178
• Device Name: R&D Series Nova Compo N
• Applicant: Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
• Product Code: EBF · Dental
• Decision Date: Dec 20, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

R&D Series Nova Compo N is a light-curing, radiopaque, nano-hybrid universal composite for anterior restorations. It is intended for professional use by below mentioned Indications for Use; - Restorations of deciduous teeth - Splinting of mobile teeth - Restoration in the posterior region (Classes I and II) - Anterior restorations (Classes III, IV) - Class V restorations (cervical caries, root erosion, wedge-shaped defects) - Extended fissure sealing in molars and premolars - Veneering of discoloured anterior teeth - Repair of composite and ceramic veneers

Device Story

R&D Series Nova Compo N is a light-curing, radiopaque, nano-hybrid universal composite material; used by dental professionals for restorative procedures. Input: light energy applied intra-orally to initiate polymerization. Transformation: high molecular weight resin matrix with prepolymerized fillers and nanofillers reduces polymerization shrinkage, improves handling, and enhances wear resistance/surface polish. Output: hardened dental restorative material. Clinical use: applied in clinic settings for cavity filling, splinting, and veneer repair. Benefit: provides durable, aesthetic, and radiopaque tooth restoration with low water absorption and high surface hardness.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-1 and ISO 7405 (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation). Physical performance tested per ISO 4049:2009, including compressive strength (360 MPa), flexural strength (130 MPa), depth of cure (>=2 mm), water sorption (21.2 µg/mm3), and radiopacity (350% Al).

Technological Characteristics

Nano-hybrid composite; resin matrix (Bis-GMA, UDMA, Bis-EMA, hydrophobic aromatic dimethacrylates); inorganic fillers (barium glass, ytterbium trifluoride); organic fillers (prepolymers); nano fillers. Light-cured (ISO 4049:2009 Type 1, Class 2, Group 1). Particle size 40 nm to 3 µm. Radiopaque. Biocompatible.

Indications for Use

Indicated for professional dental use in patients requiring restorations of deciduous teeth, splinting of mobile teeth, Class I-V restorations, extended fissure sealing in molars/premolars, veneering of discolored anterior teeth, and repair of composite/ceramic veneers.

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

• Tetric Evoceram (K042819)
• Clearfil Majesty Esthetic (K061860)

Submission Summary (Full Text)

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December 20, 2019

Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. Husamettin Sonmez General Manager Fetih Mahallesi Mahir Sokak No:5/201 Konya, 42030 Karatay TURKEY

Re: K192178

Trade/Device Name: R&D Series Nova Compo N Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF Dated: October 1, 2019 Received: October 7, 2019

Dear Husamettin Sonmez:

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

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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 "Nandu" Nandkumar, Ph.D. 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

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# Indications for Use

510(k) Number (if known)

K192178

Device Name

R&D Series Nova Compo N

Indications for Use (Describe)

R&D Series Nova Compo N is a light-curing, radiopaque, nano-hybrid universal composite for anterior restorations. It is intended for professional use by below mentioned Indications for Use;

- · Restorations of deciduous teeth
- · Splinting of mobile teeth
- · Restoration in the posterior region (Classes I and II)
- · Anterior restorations (Classes III, IV)
- · Class V restorations (cervical caries, root erosion, wedge-shaped defects)
- · Extended fissure sealing in molars and premolars
- · Veneering of discoloured anterior teeth
- · Repair of composite and ceramic veneers

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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### K192178

### 510(k) Summary

# R&D SERIES NOVA COMPO N® Light Cure Nano Hybrid Composite

Date of Summary Preparation: July 17, 2019

Type of Submission: Traditional 510(k)

#### Submitter Information:

Company Name: IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.

Company Address: Fetih Mahallesi Mahir Sokak No: 5/201 Zip Code: 42030 Karatay/Konya/TURKEY

Phone Number: 0090 444 71 30

Fax Number: 0090 332 355 76 19

Contact Person: Husamettin SONMEZ

Phone: [phone] ext: 120

E-mail: [e-mail]

#### Secondary Contact Person: Muhammed Hulusi SONMEZ

Phone: [phone]

E-mail: [e-mail]

### Device Information:

Trade Name: R&D SERIES NOVA COMPO N®

Common Name: Light Cure Nano Hybrid Composite

Product Code: EBF

Classification: Class II

Classification Name: Tooth Shade Resin Material

Regulation Number: 872.3690

Review Panel: Dental

#### Predicate Devices:

R&D Series Nova Compo N light cure nano hybrid composite is substantially equivalent to the following marketed products:

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| COMPANY | DEVICE | 510(k) NUMBER | PRODUCT CODE |
|--------------------------------|---------------------------|---------------|--------------|
| Ivoclar Vivadent, Incorporated | Tetric Evoceram | K042819 | EBF |
| Kuraray Medical, Inc. | Clearfil Majesty Esthetic | K061860 | EBF |

### Indication for Use:

R&D Series Nova Compo N is a light-curing, radiopaque, nano-hybrid universal composite for anterior and posterior restorations. It is intended for professional use by below mentioned Indications for Use;

- . Restorations of deciduous teeth
- Splinting of mobile teeth ●
- Restoration in the posterior region (Classes I and II) ●
- Anterior restorations (Classes III, IV)
- . Class V restorations (cervical caries, root erosion, wedge-shaped defects)
- . Extended fissure sealing in molars and premolars
- Veneering of discoloured anterior teeth .
- Repair of composite and ceramic veneers .

### Device Description:

R&D Series Nova Compo N is a light-curing, radiopaque, nano hybrid composite for anterior and posterior restorations.

According to the applicable FDA recognized consensus standard: ISO 4049:2009 "Dentistry-Polymer Based Restorative Materials", this device is classified into the following:

- -Type 1: polymer-based filling and restorative materials;
-Class 2: Materials whose setting is effected by light;

-Group 1: Materials whose use requires the energy to be applied intra-orally.

R&D Series Nova Compo N light cure nano hybrid composite is designed with the high reduced shrinkage resin. The higher molecular weight of the resin results in less shrinkage, reduced aging and a slightly softer resin matrix. Additionally these resins impart a greater hydrophobicity and are less water absorption. Prepolymerized fillers provide low stress, non-sticky, easy handling and shaping formulation. High loading Prepolymerized fillers provide better wear resistance than traditional less loaded Prepolymerized fillers in other marketing composites. The nanofillers provide high polish, high wear, surface hardness and making the material smooth.

R&D Series Nova Compo N light cure nano hybrid composite was tested for biocompability and found to be biocompatible as a result of testing.

### Substantial Equivalence:

The applicant device has the same intended use as the 510(k) cleared predicates listed above.

Table 1 below shows a comparison of R&D Series Nova Compo N light cure nano hybrid composite and the predicates.

### Table 1

| DESCRIPTIVE<br>INFORMATION | NEW DEVICE/R&D SERIES<br>NOVA COMPO N<br>Light cure nano hybrid<br>composite | PREDICATE/TETRIC EVOCERAM | PREDICATE/CLEARFILL<br>MAJESTY ETSHETIC |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INDICATION FOR USE | Restorations of deciduous teeth Splinting of mobile teeth Restorations in the posterior region (classes I and II) Anterior restorations (classes III, IV) | Restorations in the posterior region (Classes I and II) Anterior restorations (Classes III, IV) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Veneering of discoloured | Direct restorations for all cavity classes in anterior and posterior teeth Direct veneers Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.) |
| | Class V restorations (cervical caries, root erosion, wedge-shaped defects) Extended fissure sealing in molars and premolars Veneering of discoloured anterior teeth Repair of composite and ceramic veneers | anterior teeth Splinting of mobile teeth Repair of composite/ceramic veneers | Intraoral repairs of fractured restorations |
| COMPOSITION | | | |
| | The monomer matrix is<br>composed of<br>Bis-GMA, hydrophobic aromatic<br>dimethacrylates, UDMA,<br>Bis-EMA,<br>The fillers contain barium glass,<br>ytterbium trifluoride, nano filler<br>and prepolymer as an organic<br>filler and inorganic filler.<br>dl-Camphorquinone<br>additives,<br>initiators,<br>stabilizers<br>Accelerators<br>Pigments. | The monomer matrix is composed<br>of dimethacrylates.<br>The fillers contain barium glass,<br>ytterbium trifluoride, mixed oxide<br>and copolymers.<br>Additives,<br>Initiators,<br>Stabilizers<br>Pigments<br>Urethane dimethacrylates,<br>Bis-GMA,<br>Ytterbium trifluoride,<br>Ethyoxylated bisphenol A<br>dimethacrylates (Bis-EMA)<br>dl-Camphorquinone | Silanated barium glass filler.<br>Pre-polymerized organic filler<br>including nano filler<br>Bis-phenol A diglycidyl<br>methacrylate (Bis-GMA) .<br>Hydrophobic aromatic<br>dimethacrylate .<br>dl-Camphorquinone .<br>Initiators,<br>Accelerators<br>Pigments<br>YbF3( Ytterbium trifluoride) |
| PHYSICAL PROPERTIES | | | |
| Compressive<br>Strength (MPa) | 360 | 250 | 356 |
| Flexural Strength<br>(MPa) | 130 | 120 | 118 |
| Depth Of Cure<br>(mm) | >=2 | >1,5 | >1,5 |
| Particle Size<br>Range | 40 nm and 3 µm. | Particle Size Range: 40nm-<br>3micron | Particle Size Range: 20nm-<br>3micron |
| Water Sorption (<br>µg/mm3) | 21,2 | 21,2 | 25,3 |
| Water Solubility<br>( μg/mm3) | < 1,0 | < 1,0 | <1,5 |
| Elastic Modulus | 10 GPa | 10 GPa | 10 GPa |
| Radio-opacity<br>( mm of Al) | %350 | %400 | %180 |
| Working Time<br>(second) | 250 | 200 | 250 |
| Curing Time<br>(second) | 20 | 20 | 20 |
| Sensitivity to<br>Ambient Light<br>(second) | 250 | 200 | 250 |
| Color<br>stability | YES | YES | YES |

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# Similarities

- Tetric Evo Ceram, Clearfil Majesty and Nova Compo N are light cured glass filled nano hybrid composites. All . devices have the same basic structure. The basic structures are glass fillers and methacrylate resins.
- . Tetric Evo Ceram and Nova Compo N contain the same resin matrix is UDMA (Urethane Dimethacrylate), Bis-GMA, Bis-EMA (Ethoxylated bisphenol-A dimethacrylate) and dl-comphoroquione. Clearfil Majesty and Nova Compo N have similar resin matrix. The similar resins are Bis-gma, hydrophotic aromatic dimethacrylate, dl-comphoroquione.

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- . All devices have inorganic (ba-glass etc.) and organic fillers (prepolymers, copolymers). Tetric Evo Ceram, Nova Compo N and Clearfil Majesty are containing organic fillers are called prepolymer in Nova Compo N, Clearfil Majesty and copolymer in Tetric Evo Ceram. Basically prepolymer and copolymers mean the same material. Prepolymers are being used in composite formulations to reduce the polymerization shrinkage and improve the handling properties. Prepolymer and copolymers: The composite resins and fillers are mixed, moulded, polymerized and grind to small particles. As a result sometimes the material is called prepolymer. Copolymer is a prepolymer. Because prepolymer is produced from different base materials.
- All devices contain ba-glass, ytterbium triflouride for radiopacity as inorganic filler.
- . Nova Compo N and Clearfil Majesty also contain nano filler.
- The usage areas and purposes of the products are the same.
- Physical Property data similar to the predicate device. ●

### Differences

- Tetric Evo Ceram contains mixed oxide and Nova Compo N contains nano filler. The aim of both mixed oxide and nano filler materials are improve the surface gloss, increase mechanical properties and to fill the voids of bigger particles.
- Clearfil Majesty does not contain UDMA and Bis-EMA but Tetric Evo Ceram and Nova Compo N contain these monomer. But all devices have similar resin ratio. In Clearfil Majesty Bis-gma and hydrophobic aromatic dimethacrylate are used instead of UDMA and Bis-EMA. But it is not significant because they are both used extensively in Dental composites, have no substantial history of adverse events.

#### Non-Clinical Performance Testing:

#### Biocompatibility Testing:

In accordance with ISO 10993-1 (Biological Assessment Medical Devices-Part1: Evaluation and Testing) and ISO 7405 (Dentistry - Biocompatibility of Medical Devices used in Dentistry) standards, biocompatibility was evaluated for R & D Series Nova Compo N light cure nano hybrid composite.

The biocompatibility data for R & D Series Nova Compo N light cure nano hybrid composite are given in the table below.

| TEST NAME | RESULT |
|----------------------------|----------------------------------------------|
| In vitro cytotoxicity | Does not have cytotoxic potential |
| Sensitization | Does not cause sensitivity |
| Irritation | Does not cause irritation |
| Acute systemic toxicity | Does not have acute systemic toxic effect |
| Subacute systemic toxicity | Does not have subacute systemic toxic effect |
| Genotoxicity | Does not have genotoxic potential |
| Implantation | Irritant effect was not found |

#### Physical Properties:

In-vitro bench tests were performed on the R&D Series Nova Compo N light cure nano hybrid composite according to the requirements in ISO 4049: 2009 (Dentistry - Polymer-based restorative).

Bench tests included in support of the substantial equivalence of R&D Series Nova Compo N light cure nano hybrid composite are:

- Compressive Strength
- Flexural Strength
- •Depth of Cure
- Particle Size Range
- Water Sorption
- Water Solubility
- Elastic Modulus
- Radiopacity
- Working Time
- Curing Time
- Sensitivity to Ambient Light
- Color Stability

The results from bench tests included in this premarket notification support the substantial equivalence of the R&D Series Nova Compo N light cure nano hybrid composite.

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# Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. concludes that the R&D SERIES NOVA COMPO N light cure nano hybrid composite is safe, effective and substantially equivalent to the predicate devices as described herein. It does not introduce new indications for use, has similar technological characteristics and does not introduce new potential hazards or risks.