(258 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of dental cements, with no mention of AI or ML.
No.
The device is described as a cement for dental restorations and not as a device used to treat or cure a disease or condition.
No
Explanation: The device description and intended use clearly state that Nova Glass Cements are used for the cementation of various dental restorations and appliances, and as temporary fillings or bases/liners. These are restorative and adhesive functions, not diagnostic ones. The performance studies focus on physical properties and biocompatibility, not on detecting or identifying medical conditions.
No
The device description clearly states that the device is a cement based on the reaction of silicate glass powder and polyalkeonic acid, provided as a powder and liquid portion that are combined. This indicates a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed for the Nova Glass products are all related to dental procedures performed directly on a patient's teeth (cementation, restoration, base/liner, core build-up). These are therapeutic or restorative applications, not diagnostic ones.
- Device Description: The description focuses on the chemical composition and setting process of the cement, which is relevant to its function as a dental material. It does not mention any diagnostic purpose or the analysis of biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies described are focused on biocompatibility and physical properties relevant to a dental material's performance in the mouth, not on diagnostic accuracy or analytical performance.
In vitro diagnostics are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The Nova Glass cements do not fit this definition. They are dental materials used for treatment and restoration.
N/A
Intended Use / Indications for Use
Nova Glass L:
-Cementation of all types of metal, porcelain fused to metal, resin crowns, inlays, onlays & bridges
-Cementation of orthodontic bands
-Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns
-Base/liner
Nova Glass F:
-Class III, V and limited class I cavities
-Restoration of primary teeth
-Core Build Up
Nova Glass LC:
-Class III and V restorations
-Restoration of Cervical erosions and root surface caries
-Core build up
-Base/liner
Nova Glass BF:
-Class I & II cavities
-Decidious teeth: final restorative for Class I, II and V
-Long term restorative in non-load bearing areas of Class I, II and V
-Intermediate restorative & sandwich material for heavy stress bearing
-Core build up material
Nova Glass L Plus:
-Metal-based restorations
-Ceramic inlays
-Reinforced ceramic crowns and bridges
-All kinds of acrylic/resin crowns, inlays, onlays and bridges
Product codes
EMA
Device Description
- Nova Glass Cements are devices intended to serve as a temporary tooth filling or as a base ● cement to affix a temporary tooth filling.
- . Nova Glass Cements are based on the reaction of silicate glass powder and polyalkeonic acid. (acid-base reaction)
- . Nova Glass Cements are formulated to provide a powder and a liquid portion. In use the two are combined and a chemical reaction takes place to provide set cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 conducted in accordance with ISO 10993-1. Tests included Cytotoxicity, Acute Systemic Toxicity, Genotoxicity (OECD 487 and OECD 471), Sensitization, Subacute Systemic Toxicity, Irritation, and Implantation. Results indicate no adverse biological effects (cytotoxicity, acute systemic toxicity, genotoxic potential, mutagenic potential, sensitization, subacute systemic effect, irritation, implantation). Physical Testing focused on in-vitro bench tests according to ISO 9917-1:2007. Tests included Film Thickness, Setting Time, Compressive Strength, Acid Erosion, Opacity, Acid Soluble Pb Content, Mixing Time, and Working Time. The conclusion is that the device is safe and effective and substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
November 2, 2021
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. Hüsamettin Sonmez General Manager Fetih Mahallesi Mahir Sokak No: 5/201 Konya, Karatay 42030 Turkey
Re: K210473
Trade/Device Name: Nova Glass Cements (Nova Glass F, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: September 30, 2021 Received: October 5, 2021
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
2
Indications for Use
510(k) Number (if known) K210473
Device Name
Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)
| Indications for Use (Describe) | |
|---|---|
| Products | Indications For Use |
| Nova Glass L | -Cementation of all types of metal, porcelain fused to metal, resin crowns, inlays, onlays & |
| bridges | |
| -Cementation of orthodontic bands | |
| -Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel | |
| crowns | |
| -Base/liner | |
| Nova Glass F | -Class III, V and limited class I cavities |
| -Restoration of primary teeth | |
| -Core Build Up | |
| Nova Glass LC | -Class III and V restorations |
| -Restoration of Cervical erosions and root surface caries | |
| -Core build up | |
| -Base/liner | |
| Nova Glass BF | -Class I & II cavities |
| -Decidious teeth: final restorative for Class I, II and V | |
| -Long term restorative in non-load bearing areas of Class I, II and V | |
| -Intermediate restorative & sandwich material for heavy stress bearing | |
| -Core build up material | |
| Nova Glass L Plus | -Metal-based restorations |
| -Ceramic inlays | |
| -Reinforced ceramic crowns and bridges | |
| -All kinds of acrylic/resin crowns, inlays, onlays and bridges | |
| 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.
3
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 PRAStaff@fda.hhs.gov
"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."
4
Image /page/4/Picture/0 description: The image shows the logo for IMICRYL. The logo consists of a circular emblem with the letters "IMI" inside, followed by the word "IMICRYL" in bold, blue letters. Below the logo is the text "DIS MALZEMELERI SAN. VE TIC A.S."
510(k) Summary
NOVA GLASS CEMENTS (NOVA GLASS L, NOVA GLASS F, NOVA GLASS LC, NOVA GLASS BF, NOVA GLASS L PLUS)
Date of Summary Preparation: September 28, 2021
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 Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)
510(k) Number: K210473
Common Name: Glass Ionomer Cements
Product Code: EMA
Classification: Class II
Classification Name: Cement, Dental
Regulation Number: 872.3275
Review Panel: Dental
5
Image /page/5/Picture/0 description: The image shows the logo for IMICRYL. The logo consists of a blue oval shape with the letters "IMI" inside, followed by the word "IMICRYL" in large, bold, blue letters. Below the word "IMICRYL" is the text "DİŞ MALZEMELERİ SAN. VE TİC A.Ş." in smaller, blue letters.
PREDICATE DEVICES:
Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) is substantially equivalent to the following marketed product:
| COMPANY | DEVICE | 510(k) NUMBER | PRODUCT CODE |
|---|---|---|---|
| Silmet Ltd. | ProGlass Cements (ProGlass One, | ||
| ProGlass Two, ProGlass Two LC, ProGlass | |||
| Nine, ProGlass Plus, ProGlass Silver) | K101869 | ||
| (Primary Predicate) | EMA |
INDICATION FOR USE:
| Nova Glass L | -Cementation of all types of metal, Porcelain fused to metal, resin crowns, inlays,
onlays & bridges
-Cementation of orthodontic bands
-Cementation of stainless steel crowns or orthodontic appliances retained with
stainless steel crowns
-Base/liner |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Nova Glass F | -Class III, V and limited class I cavities
-Restoration of primary teeth
-Core Build Up |
| Nova Glass LC | -Class III and V restorations
-Restoration of Cervical erosions and root surface caries
-Core Build Up
-Base/Liner |
| Nova Glass BF | -Class I & II cavities
-Decidious teeth: final restorative for Class I, II and V
-Long term restorative in non-load bearing areas of Class I, II and V
-Intermediate restorative & sandwich material for heavy stress bearing
-Core build up material |
| Nova Glass L Plus | -Metal-based restorations
-Ceramic inlays
-Reinforced ceramic crowns and bridges
-All kind of acrylic/resin crowns, inlays, onlays and bridges |
DEVICE DESCRIPTION:
- Nova Glass Cements are devices intended to serve as a temporary tooth filling or as a base ● cement to affix a temporary tooth filling.
- . Nova Glass Cements are based on the reaction of silicate glass powder and polyalkeonic acid. (acid-base reaction)
- . Nova Glass Cements are formulated to provide a powder and a liquid portion. In use the two are combined and a chemical reaction takes place to provide set cement.
6
Image /page/6/Picture/0 description: The image shows the logo for IMICRYL. The logo consists of the word "IMICRYL" in large, bold, blue letters, with a registered trademark symbol to the right of the word. To the left of the word is a blue circle containing the letters "IMI" in white. Below the word "IMICRYL" is the text "DİŞ MALZEMELERİ SAN. VE TİC A.Ş." in smaller, blue letters.
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 Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) and the predicates.
Table 1
| DESCRIPTIVE
INFORMATION | NEW DEVICE
NOVA GLASS CEMENTS (K210473) | PREDICATE DEVICE
ProGlass Cements (K101869) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INDICATIONS FOR USE | | |
| | Nova Glass L
-Cementation of all types of metal,
Porcelain fused to metal, resin crowns,
inlays, onlays & bridges
-Cementation of orthodontic bands
-Cementation of stainless steel crowns
or orthodontic appliances retained with
stainless steel crowns
-Base/liner | ProGlass One
-Cementation of all types of metal,
Porcelain fused to metal, resin crowns,
inlays, onlays & bridges
-Cementation of orthodontic bands
-Cementation of stainless steel crowns
or orthodontic appliances retained with
stainless steel crowns
-Base/liner |
| | Nova Glass F
-Class III, V and limited class I cavities
-Restoration of primary teeth
-Core Build Up | ProGlass Two
-Class III, V and limited class I cavities
-Restoration of primary teeth
-Core Build Up |
| | Nova Glass LC
-Class III and V restorations
-Restoration of Cervical erosions and
root surface caries
-Core Build Up
-Base/Liner | ProGlass Two LC
-Class III and V restorations
-Restoration of Cervical erosions and
root surface caries
-Core Build Up
-Base/Liner |
| | Nova Glass BF
-Class I & II cavities
-Decidious teeth: final restorative for
Class I, II and V
-Long term restorative in non-load
bearing areas of Class I, II and V
-Intermediate restorative & sandwich
material for heavy stress bearing
-Core build up material | ProGlass Nine
-Class I & II cavities
-Decidious teeth: final restorative for
Class I, II and V
-Long term restorative in non-load
bearing areas of Class I, II and V
-Intermediate restorative & sandwich
material for heavy stress bearing
-Core build up material |
| | Nova Glass L Plus
-Metal-based restorations
-Ceramic inlays
-Reinforced ceramic crowns and
bridges
-All kind of acrylic/resin crowns, inlays,
onlays and bridges | ProGlass Plus
-Metal-based restorations
-Ceramic inlays
-Reinforced ceramic crowns and
bridges
-All kind of acrylic/resin crowns, inlays,
onlays and bridges |
| FUNCTION | | |
| | Nova Glass L
Luting Cement | ProGlass One
Luting Cement |
| | Nova Glass F
Restorative | ProGlass Two
Restorative |
| | Nova Glass LC | ProGlass Two LC |
7
Image /page/7/Picture/0 description: The image shows the logo for IMICRYL. The logo consists of a circular emblem on the left and the word "IMICRYL" in large, bold, blue letters on the right. The emblem features the letters "IMI" inside a stylized shape resembling a tooth or a leaf, all enclosed within a blue circle.
DİŞ MALZEMELERİ SA
| Nova Glass BF | ProGlass Nine | ||||
|---|---|---|---|---|---|
| Restorative | |||||
| Base/Liner | Restorative | ||||
| Base/Liner | |||||
| Nova Glass L Plus | |||||
| Luting Cement | ProGlass Plus | ||||
| Luting Cement | |||||
| COMPOSITION | Nova Glass L | ||||
| Powder: Alumino-silicate glass, polyacrylic acid | |||||
| Liquid: Distilled water, polyacrylic acid | ProGlass One | ||||
| Powder: Alumino-silicate glass, polyacrylic acid | |||||
| Liquid: Distilled water, polyacrylic acid | |||||
| Nova Glass F | |||||
| Powder: Alumino-silicate glass, polyacrylic acid | |||||
| Liquid: Distilled water, polyacrylic acid | ProGlass Two | ||||
| Powder: Alumino-silicate glass, polyacrylic acid | |||||
| Liquid: Distilled water, polyacrylic acid | |||||
| Nova Glass LC | |||||
| Powder: Alumino-silicate glass | |||||
| Liquid: Distilled water, polyacrylic acid, 2-hydroxyethyl methacrylate (HEMA), 2,2,4, Trimethyl hexamethylene dicarbonate (TMHMD) | ProGlass Two LC | ||||
| Powder: Alumino-silicate glass | |||||
| Liquid: Distilled water, polyacrylic acid, 2-hydroxyethyl methacrylate (HEMA), 2,2,4, Trimethyl hexamethylene dicarbonate (TMHMD) | |||||
| Nova Glass BF | |||||
| Powder: Alumino-silicate glass, polyacrylic acid | |||||
| Liquid: Polyacrylic acid, tartaric acid, distilled water | ProGlass Nine | ||||
| Powder: Alumino-silicate glass, polyacrylic acid | |||||
| Liquid: Polyacrylic acid, tartaric acid, distilled water | |||||
| Nova Glass L Plus | |||||
| Powder: Alumino-silicate glass | |||||
| Liquid: Distilled water, polyacrylic acid, 2-Hydroxyethylmethacrylate, Urethanedimethacrylate | ProGlass Plus | ||||
| Powder: Alumino-silicate glass | |||||
| Liquid: Distilled water, polyacrylic acid, 2-Hydroxyethylmethacrylate, Urethanedimethacrylate | |||||
| PHYSICAL PROPERTIES | Nova Glass L & ProGlass One | Nova Glass F & ProGlass Two | Nova Glass LC & ProGlass Two LC | Nova Glass BF & ProGlass Nine | Nova Glass L Plus & ProGlass Plus |
| Powder/Liquid | 2.4 / 1.0 | 3.5 / 1.0 | 2.3 / 1.0 | 4.1 / 1.0 | 1.5 / 1.0 |
| Mixing Time (sec) | 30" | 30" | 30" | 30" | 30" |
| Working Time (min. sec) | 2'30"- 3" | 1'30"- 2' | 3' | 2'30" | 3' |
| Setting Time (min. sec) | 3'10" - | 3' 10"- 3' | 3' | 3' 30" | 3' |
| Light Cure (sec) | 20" |
Similarities
- Nova Glass Cements; 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 as safety and as effectiveness of Nova Glass Cements for the intended use.
Differences
- There is no silver-containing version of Nova Glass Cements. ●
8
Image /page/8/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 large, bold, blue letters. Below the logo is the text "DIŞ MALZEMELERI SAN. VE TIC A.Ş." in smaller, blue letters.
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 Glass Cements (Nova Glass F. The biocompatibility data for Nova Glass Cements (Nova Glass F) are given in the table below.
| Test Name | Report Number | Result |
|---|---|---|
| Cytotoxicity | BU-2021/07-ST | It does not cause cytotoxicity. |
| Acute Systemic Toxicity | 2018-IVV-AST-105-213 | It does not cause acute systemic toxicity. |
| Genotoxicity (OECD 487) | 2019-.09.170 | It has no genotoxic potential. |
| Genotoxicity (OECD 471) | 2020.07.226 | It does not have mutagenic potential. |
| Sensitization | 2017-IVV-SEN-112-160 | It does not cause sensitization. |
| Subacute Systemic Toxicity | 2018-IVV-SST-104-209 | It does not have a subacute systemic effect. |
| Irritation | 2017-IVV-IRT-112-119 | It does not cause irritation. |
| Implantation | 2019.12.256 | It does not cause implantation. |
Material-Mediated Pyrogenicity;
Nova Glass L and Nova Glass F components are found in the legally marketed devices:
The material, design and use concept is similar.
We believe that the prior use of these components in legally marketed device and the performance data and results support the substantial equivalence of Nova Glass Cements for the intended use.
Chronic Toxicity;
Nova Glass L and Nova Glass F components are found in the legally marketed devices:
The material, design and use concept is similar.
We believe that the prior use of these components in legally marketed device and the performance data and results support the substantial equivalence of Nova Glass Cements for the intended use.
Carcinogenicity;
Nova Glass L and Nova Glass F components are found in the legally marketed devices:
The material, design and use concept is similar.
We believe that the prior use of these components in legally marketed device and the performance data and results support the substantial equivalence of Nova Glass Cements for the intended use.
9
Image /page/9/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 large, bold, blue letters. Below the word is the text "DIS MALZEMELERI SAN. VE TIC A.S." in smaller, blue letters.
Nova Glass Cements (Nova Glass LC, Nova Glass BF, Nova Glass L Plus)
Nova Glass Cements (Nova Glass LC, Nova Glass BF, Nova Glass L Plus) components are found in the legally marketed devices:
The material, design and use concept is similar.
Biocompatibility testing has not been performed for our Nova Glass LC, Nova Glass BF, Nova Glass L Plus products.
We believe that the prior use of these components in legally marketed device and the performance data and results support the substantial equivalence of Nova Glass Cements for the intended use.
The prior use of all the components in the legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional bio-compatibility studies with the final formulation are not necessary.
Physical Testing:
In-vitro bench tests were performed on the Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) according to the requirements in ISO 9917-1:2007 (Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements).
Bench tests included in support of the substantial equivalence of Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) are:
- Film Thickness
- Setting Time ●
- Compressive Strength
- Acid Erosion
- Opacity
- Acid Soluble Pb Content ●
- . Mixing Time
- Working Time
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 Glass Cements (Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) are as safe and as 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.