(130 days)
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
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.
The user is asking for specific details about the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA 510(k) summary.
Here's an analysis of the provided text and the answers to your questions:
The provided document is an FDA 510(k) premarket notification for a dental composite material, R&D Series Nova Compo N. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically addressed through comparison to established standards (like ISO) and predicate device performance, along with bench testing.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a separate section. Instead, it presents the performance of the new device (R&D Series Nova Compo N) in comparison to the performance of its predicate devices, implying that performance similar to or better than the predicates, and adherence to relevant ISO standards, constitutes the "acceptance criteria."
The closest representation of this is Table 1 in the "Substantial Equivalence" section of the document, which compares the physical properties of the new device with its predicates. The "acceptance criteria" can be inferred as being at least equivalent to the predicate devices and meeting the requirements of the ISO 4049:2009 standard.
Inferred Acceptance Criteria and Reported Device Performance (from Table 1 and text):
| Physical Property | Device Acceptance Criteria (Inferred from Predicates & ISO 4049:2009) | R&D Series Nova Compo N Performance |
|---|---|---|
| Compressive Strength (MPa) | ≥ 250 MPa (based on predicate Tetric Evoceram) | 360 |
| Flexural Strength (MPa) | ≥ 118 MPa (based on predicate Clearfil Majesty Esthetic) | 130 |
| Depth Of Cure (mm) | > 1.5 mm (based on predicates) | ≥ 2 |
| Particle Size Range | Similar to predicates (40 nm - 3 µm is acceptable) | 40 nm and 3 µm. |
| Water Sorption (µg/mm³) | ≤ 25.3 µg/mm³ (based on predicate Clearfil Majesty Esthetic) | 21.2 |
| Water Solubility (µg/mm³) | ≤ 1.5 µg/mm³ (based on predicate Clearfil Majesty Esthetic) | < 1.0 |
| Elastic Modulus | Around 10 GPa (consistent with predicates) | 10 GPa |
| Radio-opacity (mm of Al) | Within a functional range for dental composites (e.g., 180%-400%) | 350% |
| Working Time (second) | Similar to predicates (e.g., 200-250 seconds) | 250 |
| Curing Time (second) | Similar to predicates (e.g., 20 seconds) | 20 |
| Sensitivity to Ambient Light (second) | Similar to predicates (e.g., 200-250 seconds) | 250 |
| Color stability | YES (consistent with predicates) | YES |
| Biocompatibility | Must meet ISO 10993-1 and ISO 7405 standards | Biocompatible |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the physical property bench tests. It states, "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)." ISO standards typically specify minimum sample sizes for various tests, but these specific numbers are not detailed in the summary.
- Sample Size for Test Set: Not explicitly stated for individual tests.
- Data Provenance: The studies are in-vitro bench tests and biocompatibility tests. No mention of human patient data (retrospective or prospective) for performance evaluation. The submitting company is IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. from Turkey, so it can be inferred the testing was conducted under their purview, likely in Turkey or by an accredited lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the studies are primarily in-vitro bench tests and biocompatibility tests. "Ground truth" in the clinical sense (e.g., expert consensus on medical images or pathology reports) is not required or established for this type of device and testing. The ground truth for these tests comes from the established physical and chemical properties as measured by standardized laboratory methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the in-vitro bench tests and biocompatibility studies described. Adjudication methods are typically employed in clinical studies or studies involving human interpretation of data (e.g., medical imaging) to resolve discrepancies.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a dental composite material, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant nor were they conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a dental composite material, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical properties, the "ground truth" is established by standardized laboratory measurements according to ISO 4049:2009. For biocompatibility, the "ground truth" is established by laboratory tests according to ISO 10993-1 and ISO 7405, which determine the biological response (e.g., cytotoxicity, sensitization). There is no "expert consensus" or "pathology" in the medical diagnostic sense for these tests.
8. The sample size for the training set
This is not applicable. Since this device is a physical material (dental composite) and not an AI algorithm, there is no "training set."
9. How the ground truth for the training set was established
This is not applicable as there is no "training set" for a physical dental composite device.
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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 and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (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
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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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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
| DESCRIPTIVEINFORMATION | NEW DEVICE/R&D SERIESNOVA COMPO NLight cure nano hybridcomposite | PREDICATE/TETRIC EVOCERAM | PREDICATE/CLEARFILLMAJESTY 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 iscomposed ofBis-GMA, hydrophobic aromaticdimethacrylates, UDMA,Bis-EMA,The fillers contain barium glass,ytterbium trifluoride, nano fillerand prepolymer as an organicfiller and inorganic filler.dl-Camphorquinoneadditives,initiators,stabilizersAcceleratorsPigments. | The monomer matrix is composedof dimethacrylates.The fillers contain barium glass,ytterbium trifluoride, mixed oxideand copolymers.Additives,Initiators,StabilizersPigmentsUrethane dimethacrylates,Bis-GMA,Ytterbium trifluoride,Ethyoxylated bisphenol Adimethacrylates (Bis-EMA)dl-Camphorquinone | Silanated barium glass filler.Pre-polymerized organic fillerincluding nano fillerBis-phenol A diglycidylmethacrylate (Bis-GMA) .Hydrophobic aromaticdimethacrylate .dl-Camphorquinone .Initiators,AcceleratorsPigmentsYbF3( Ytterbium trifluoride) | |
| PHYSICAL PROPERTIES | |||
| CompressiveStrength (MPa) | 360 | 250 | 356 |
| Flexural Strength(MPa) | 130 | 120 | 118 |
| Depth Of Cure(mm) | >=2 | >1,5 | >1,5 |
| Particle SizeRange | 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) | < 1,0 | < 1,0 | <1,5 |
| Elastic Modulus | 10 GPa | 10 GPa | 10 GPa |
| Radio-opacity( mm of Al) | %350 | %400 | %180 |
| Working Time(second) | 250 | 200 | 250 |
| Curing Time(second) | 20 | 20 | 20 |
| Sensitivity toAmbient Light(second) | 250 | 200 | 250 |
| Colorstability | 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.
§ 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.