(130 days)
Not Found
No
The device description focuses on the material properties and performance characteristics of a dental composite, with no mention of AI or ML.
No.
The device is a dental restorative material used for filling cavities and other dental repairs, not a device that provides therapy for diseases or conditions.
No
Explanation: The device is a dental restorative material (composite) used for filling and repairing teeth, not for diagnosing medical conditions. Its intended uses are for restorations, splinting, and sealing.
No
The device is a light-curing, radiopaque, nano-hybrid universal composite, which is a physical material used for dental restorations. The description focuses on the material properties and bench testing, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "light-curing, radiopaque, nano-hybrid universal composite for anterior restorations" and lists various dental restoration procedures. This indicates it is a material used in the body for treatment, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details the composition and properties of a dental filling material. It discusses its classification according to dental material standards (ISO 4049), not diagnostic testing standards.
- Performance Studies: The performance studies described are bench tests evaluating the physical and mechanical properties of the material (compressive strength, flexural strength, depth of cure, etc.), which are relevant to its function as a dental restorative material, not its ability to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
In summary, the R&D Series Nova Compo N is a dental restorative material used for filling cavities and other dental procedures, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
EBF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth (anterior and posterior)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional use
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 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.
Key results:
- 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:
- 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
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key Physical Properties:
- Compressive Strength: 360 MPa
- Flexural Strength: 130 MPa
- Depth Of Cure: >=2 mm
- Particle Size Range: 40 nm and 3 µm.
- Water Sorption: 21,2 μg/mm3
- Water Solubility:
§ 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
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
510(k) Number (if known)
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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3
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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: +90 444 71 30 ext: 120
E-mail: sonmez@imicryl.com.tr
Secondary Contact Person: Muhammed Hulusi SONMEZ
Phone: +90 542 372 27 23
E-mail: hsonmez@imicryl.com.tr
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
INFORMATION | NEW DEVICE/R&D SERIES
NOVA COMPO N
Light cure nano hybrid
composite | PREDICATE/TETRIC EVOCERAM | PREDICATE/CLEARFILL
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
composed of
Bis-GMA, hydrophobic aromatic
dimethacrylates, UDMA,
Bis-EMA,
The fillers contain barium glass,
ytterbium trifluoride, nano filler
and prepolymer as an organic
filler and inorganic filler.
dl-Camphorquinone
additives,
initiators,
stabilizers
Accelerators
Pigments. | The monomer matrix is composed
of dimethacrylates.
The fillers contain barium glass,
ytterbium trifluoride, mixed oxide
and copolymers.
Additives,
Initiators,
Stabilizers
Pigments
Urethane dimethacrylates,
Bis-GMA,
Ytterbium trifluoride,
Ethyoxylated bisphenol A
dimethacrylates (Bis-EMA)
dl-Camphorquinone | Silanated barium glass filler.
Pre-polymerized organic filler
including nano filler
Bis-phenol A diglycidyl
methacrylate (Bis-GMA) .
Hydrophobic aromatic
dimethacrylate .
dl-Camphorquinone .
Initiators,
Accelerators
Pigments
YbF3( Ytterbium trifluoride) |
| PHYSICAL PROPERTIES | | | |
| Compressive
Strength (MPa) | 360 | 250 | 356 |
| Flexural Strength
(MPa) | 130 | 120 | 118 |
| Depth Of Cure
(mm) | >=2 | >1,5 | >1,5 |
| Particle Size
Range | 40 nm and 3 µm. | Particle Size Range: 40nm-
3micron | Particle Size Range: 20nm-
3micron |
| Water Sorption (
µg/mm3) | 21,2 | 21,2 | 25,3 |
| Water Solubility
( μg/mm3) |