(267 days)
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No
The document describes a dental resin cement and its physical properties and performance in bench tests. There is no mention of AI or ML.
No
The device is a resin cement used for dental restorations, which is not considered a therapeutic device.
No
This device is a resin cement used for the permanent cementation of dental restorations. It is a material used for treatment, not for diagnosing conditions.
No
The device description clearly indicates it is a physical resin cement material used for dental restorations, not a software product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this product is a resin cement for the cementation of dental restorations (inlays, onlays, bridges, posts, veneers, crowns). It is applied directly to the patient's teeth and the dental restoration, not used to test a sample taken from the body.
- The performance studies are bench tests. The studies described are in-vitro bench tests evaluating the physical and mechanical properties of the cement itself (film thickness, strength, setting time, etc.). These are not studies evaluating the diagnostic performance of a test on biological samples.
This device is a dental material used for restorative procedures, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Nova Resin dual cure, self adhesive resin cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, bridges, posts and veneers. *
Additional indications include core-buildup material, pit and fissure sealant, and cementation of crowns restorations to implants.
- Adhesive application on the prep is required for veneer cementation using Nova Resin dual cure, self adhesive resin cement.
Product codes (comma separated list FDA assigned to the subject device)
EMA, EBC, EBF
Device Description
Resin Cement dual cure, self adhesive resin cement for the cementation of indirect restorations made of high strength all ceramic, composite, metal-ceramic and metal.
When Resin Cement dual cure, self adhesive resin cement is used, additional bonding agents are not required. The automix double syringe enables saving time direct application of the luting cement into restoration.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing was conducted.
Biocompatibility Testing:
In accordance with ISO 10993-1 (Biological Assessment Medical Devices-Part1: Evaluation and Testing) standard, biocompatibility was evaluated for Nova Resin dual cure, self adhesive resin cement. According to the test results, the device; is biocompatible.
Physical Testing:
In-vitro bench tests were performed on the Nova Resin dual cure, self adhesive resin cement according to the requirements in TS EN ISO 4049:2019.
Bench tests included in support of the substantial equivalence of Nova Resin dual cure, self adhesive resin cement are:
- Film Thickness
- Working Time
- Setting Time
- Flexural Strength
- Water Sorption and Solubility
- Radio-opacity
- Compressive Strength
- Elastic Modulus
- Intensity for Curing
- Depth of Cure
- Wavelength for Curing
- Surface Hardness
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Film Thickness (μm): 17
Working Time (sec.): 150
Setting Time (min.): 3'10"
Flexural Strength (Mpa): 130
Water Sorption (µg/mm³): 9.8
Water Solubility (µg/mm³): 6.9
Radio-Opacity (mm of Al): 7
Compressive Strength (MPa): 360
Elastic Modulus (GPa): 4±0.5
Intensity for Curing (second): 10
Depth of Cure (mm): 2
Wavelength for Curing (nm): 470
Particle Size (μm): 1.5
Surface Hardness (KHN): 7
Curing Time (second): 10
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 9, 2022
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. Hüsamettin Sonmez General Manager Fetih Mahallesi Mahir Sokak No:5/201 Konya, Karatay 42030 Turkey
Re: K213609
Trade/Device Name: NOVA RESIN dual cure, self adhesive resin cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA, EBC, EBF Dated: May 31, 2022 Received: June 6, 2022
Dear Hüsamettin 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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 Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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
NOVA RESIN dual cure, self adhesive resin cement
Indications for Use (Describe)
Nova Resin dual cure, self adhesive resin cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, bridges, posts and veneers. *
Additional indications include core-buildup material, pit and fissure sealant, and cementation of crowns restorations to implants.
- Adhesive application on the prep is required for veneer cementation using Nova Resin dual cure, self adhesive resin cement.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 201.2 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for IMICRYL. The logo consists of a blue circle with the letters "IMI" inside, followed by the word "IMICRYL" in blue, with a registered trademark symbol. Below the word "IMICRYL" is the text "DIŞ MALZEMELERI SAN. VE TIC A.Ş." in smaller blue font.
K213609
510(k) Summary
NOVA RESIN Dual cure, self adhesive resin cement
Date of Summary Preparation: December 28, 2020
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: 0090 444 71 30 ext: 120
E-mail: kaliteguvence@imicryl.com
Secondary Contact Person: Muhammed Hulusi SONMEZ
Phone: 0090 542 372 27 23
E-mail: hsonmez@imicryl.com.tr
DEVICE INFORMATION:
Trade Name: NOVA RESIN dual cure, self adhesive resin cement
Common Name: Dental Cement
Primary Product Code: EMA
Secondary Product Code: EBF, EBC
Classification: Class II
Classification Name: Cement, Dental
Regulation Number: 872.3275
Review Panel: Dental
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Image /page/4/Picture/0 description: The image shows the logo for IMICRYL. The logo consists of a circular graphic with the letters "IMI" inside, followed by the word "IMICRYL" in large, bold, blue letters. Below the word is the text "DIŞ MALZEMELERI SAN. VE TIC A.Ş." in smaller, black letters.
PREDICATE DEVICES:
Nova Resin dual cure, self adhesive resin cement is substantially equivalent to the following marketed product:
| COMPANY | DEVICE | 510(k) NUMBER | PRODUCT CODE |
|---|---|---|---|
| Kerr Corporation | Maxcem 2 | K073209 | MZW, EMA |
INDICATION FOR USE:
Nova Resin dual cure, self adhesive resin cement is intended for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, bridges, posts and veneers.*
Additional indications include core-buildup material, pit and fissure sealant, and cementation of crowns restorations to implants.
*Adhesive application on the prep is required for veneer cementation using Nova Resin dual cure, self adhesive resin cement.
DEVICE DESCRIPTION:
Resin Cement dual cure, self adhesive resin cement for the cementation of indirect restorations made of high strength all ceramic, composite, metal-ceramic and metal.
When Resin Cement dual cure, self adhesive resin cement is used, additional bonding agents are not required. The automix double syringe enables saving time direct application of the luting cement into restoration.
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 Nova Resin dual cure, self adhesive resin cement and the predicates.
| DESCRIPTIVE
| INFORMATION | NEW DEVICE | PREDICATE DEVICE |
|---|---|---|
| NOVA RESIN Dual Cure, Self | ||
| Adhesive Resin Cement | ||
| (K213609) | Maxcem2 (K073209) | |
| INDICATIONS FOR USE | Nova Resin dual cure, self- | |
| adhesive resin cement is | ||
| intended for cementation of all | ||
| indirect restorations including | ||
| ceramic, resin and metal-based | ||
| inlays, onlays, bridges, posts and | Maxcem 2 is intended for cementation | |
| of all indirect restorations including | ||
| ceramic, resin and metal-based inlays, | ||
| onlays, bridges, posts and veneers.* | ||
| Additional indications include core- | ||
| buildup material, pit and fissure |
Table 1: Comparison with Predicate Device
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Image /page/5/Picture/0 description: The image shows the logo for IMICRYL. The logo consists of a blue circle with a white oval inside, containing the letters "IMI" in blue. To the right of the circle is the word "IMICRYL" in large, bold, blue letters, with a registered trademark symbol above the "L". A thin blue line runs horizontally beneath the logo.
DIŞ MALZEMELERI SAN. VE TIC A.Ş.
| PHYSICAL PROPERTIES | ||
|---|---|---|
| veneers.* | ||
| Additional indications include | ||
| core-buildup material, pit and | ||
| fissure sealant, and cementation | ||
| of crowns restorations to | ||
| implants. | ||
| *Adhesive application on the | ||
| prep is required for veneer | ||
| cementation using Nova Resin | ||
| dual cure, self-adhesive resin | ||
| cement. | sealant, and cementation of crowns | |
| restorations to implants. | ||
| *Adhesive application on the prep is | ||
| required for veneer cementation using | ||
| Maxcem2. | ||
| Film Thickness (μm) | 17 | 15 |
| Working Time (sec.) | 150 | 120 |
| Setting Time (min.) | 3'10" | 3' |
| Flexural Strength (Mpa) | 130 | 112 |
| Water Sorption | ||
| (µg/mm³) | 9.8 | 9.4 |
| Water Solubility | ||
| (µg/mm³) | 6.9 | 6.5 |
| Radio-Opacity (mm of Al) | 7 | 6 |
| Compressive Strength (MPa) | 360 | 351 |
| Elastic Modulus (GPa) | 4±0.5 | 4±0.5 |
| Intensity for Curing (second) | 10 | 10 |
| Depth of Cure (mm) | 2 | 1.5 |
| Wavelength for Curing (nm) | 470 | 470 |
| Particle Size (μm) | 1.5 | 2 |
| Surface Hardness (KHN) | 7 | 8 |
| Curing Time (second) | 10 | 10 |
Similarities
- . Nova Resin dual cure, self adhesive resin cement; it is exactly similar to the equivalent device in terms of composition, indications for use, function and physical properties.
- . We believe that the prior use of these components in legally marketed devices and the performance data and results support the safety and effectiveness of Nova Resin dual cure, self adhesive resin cement for the intended use.
Differences
- . Although the composition amount of the equivalent product is not known exactly, it can be thought that the compositions are the same because the performance test results are the same.
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Image /page/6/Picture/0 description: The image is a logo for IMICRYL. The logo consists of a blue circle with the letters "IMI" inside of a white shape that resembles a tooth. To the right of the circle is the word "IMICRYL" in blue, and below the circle and word is the phrase "DIŞ MALZEMELERI SAN. VE TIC A.Ş." in blue.
NON-CLINICAL PERFORMANCE TESTING:
Biocompatibility Testing:
In accordance with ISO 10993-1 (Biological Assessment Medical Devices-Part1: Evaluation and Testing) standard, biocompatibility was evaluated for Nova Resin dual cure, self adhesive resin cement. According to the test results, the device; is biocompatible.
Physical Testing:
In-vitro bench tests were performed on the Nova Resin dual cure, self adhesive resin cement according to the requirements in TS EN ISO 4049:2019.
Bench tests included in support of the substantial equivalence of Nova Resin dual cure, self adhesive resin cement are:
- Film Thickness
- Working Time
- Setting Time
- Flexural Strength
- Water Sorption and Solubility
- Radio-opacity
- Compressive Strength
- Elastic Modulus
- Intensity for Curing
- Depth of Cure
- Wavelength for Curing
- Surface Hardness
CONCLUSION
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 872.3275, and based on the information provided in this pre-market notification, IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. concludes that the Nova Resin dual cure, self adhesive resin cement 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.