(258 days)
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
- 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.
The provided text is a 510(k) Premarket Notification for dental cements (Nova Glass Cements). This document focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily through comparison of indications for use, functional characteristics, composition, and physical properties, along with biocompatibility testing results.
Crucially, this document does not describe a study involving an AI/software device that requires human expert review for ground truth or MRMC studies. The device in question is a material-based dental cement. Therefore, many of the requested elements related to AI algorithm performance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the physical and biological properties testing conducted on the dental cements themselves, to show they perform comparably to their predicate devices and meet established standards for safety and effectiveness.
Here's a breakdown of the relevant information provided in the document:
Acceptance Criteria and Device Performance (for a Dental Cement)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of "acceptance criteria" against which a study directly proves the device meets them in the way one might for an AI algorithm's performance metrics (e.g., sensitivity, specificity). Instead, it demonstrates substantial equivalence by comparing the physical properties of the new device to its predicate devices and showing biocompatibility testing results against general safety standards.
Here's how the information can be presented for the dental cements, drawing from Section "PHYSICAL PROPERTIES" on page 7 and "NON-CLINICAL PERFORMANCE TESTING" on page 8.
| Acceptance Criteria Category | Specific Test/Property | Predicate Device Standard / Expected Range (Implied by Predicate) | Reported Device Performance (Nova Glass Cements) |
|---|---|---|---|
| Physical Properties | Powder/Liquid Ratio | Matching predicate values for each product type | Matched predicate values (e.g., Nova Glass L & ProGlass One: 2.4/1.0, Nova Glass F & ProGlass Two: 3.5/1.0, etc.) |
| Mixing Time | 30 seconds (for all predicate products) | 30 seconds (for all Nova Glass products) | |
| Working Time | Matching predicate values for each product type | Matched predicate values (e.g., Nova Glass L: 2'30"-3", Nova Glass F: 1'30"-2', etc.) | |
| Setting Time | Matching predicate values for each product type | Matched predicate values (e.g., Nova Glass L: 3'10", Nova Glass F: 3'10"-3', etc.) | |
| Light Cure (Nova Glass LC) | 20 seconds | 20 seconds | |
| Film Thickness | (Implicitly meets ISO 9917-1:2007 requirements) | Bench tested according to ISO 9917-1:2007 | |
| Compressive Strength | (Implicitly meets ISO 9917-1:2007 requirements) | Bench tested according to ISO 9917-1:2007 | |
| Acid Erosion | (Implicitly meets ISO 9917-1:2007 requirements) | Bench tested according to ISO 9917-1:2007 | |
| Opacity | (Implicitly meets ISO 9917-1:2007 requirements) | Bench tested according to ISO 9917-1:2007 | |
| Acid Soluble Pb Content | (Implicitly meets ISO 9917-1:2007 requirements) | Bench tested according to ISO 9917-1:2007 | |
| Biocompatibility | Cytotoxicity | No cytotoxicity | "It does not cause cytotoxicity." |
| Acute Systemic Toxicity | No acute systemic toxicity | "It does not cause acute systemic toxicity." | |
| Genotoxicity (OECD 487) | No genotoxic potential | "It has no genotoxic potential." | |
| Genotoxicity (OECD 471) | No mutagenic potential | "It does not have mutagenic potential." | |
| Sensitization | No sensitization | "It does not cause sensitization." | |
| Subacute Systemic Toxicity | No subacute systemic effect | "It does not have a subacute systemic effect." | |
| Irritation | No irritation | "It does not cause irritation." | |
| Implantation | No implantation effect | "It does not cause implantation." |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is primarily non-clinical performance testing, consisting of:
- Physical Testing: In-vitro bench tests performed on all Nova Glass Cements according to the requirements of ISO 9917-1:2007 (Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements).
- Biocompatibility Testing: Conducted in accordance with ISO 10993-1 (Biological Assessment Medical Devices - Part 1: Evaluation and Testing) standard, specifically for Nova Glass F as a representative. For other products (Nova Glass LC, Nova Glass BF, Nova Glass L Plus), equivalence is asserted based on existing components in legally marketed devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for the physical or biocompatibility tests. For physical properties, it states "In-vitro bench tests were performed." For biocompatibility, it lists test names and "Report Numbers" but not the sample sizes used in those reports.
- Data Provenance: The tests were conducted to support a submission from a Turkish company (IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.). The testing itself would likely have been done in a laboratory environment, but the origin of the "data" itself isn't described as retrospective or prospective patient data, as this is a material-based device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable: This criterion is for AI/software devices requiring human expert review to establish ground truth. For dental cements, ground truth is established by standardized laboratory testing procedures and the results are objective measurements (e.g., setting time, strength, toxicity).
4. Adjudication Method for the Test Set
- Not Applicable: This is an AI/software specific criterion for resolving discrepancies among human annotators.
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
- Not Applicable: This is an AI/software specific criterion. No human readers or AI assistance are involved in the function or testing of these dental cements.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is an AI/software specific criterion. There is no algorithm.
7. The Type of Ground Truth Used
- Objective Laboratory Measurements/Standards:
- Physical Properties: The ground truth for physical properties (e.g., film thickness, setting time, compressive strength) is based on the methods and limits defined in the international standard ISO 9917-1:2007 for water-based cements. The device demonstrates compliance with these established empirical standards and similarity to the predicate devices.
- Biocompatibility: The ground truth for biocompatibility is based on the negative/positive control findings and criteria for safe biological response defined by ISO 10993-1 and specific test methodologies (e.g., OECD guidelines for genotoxicity).
8. The Sample Size for the Training Set
- Not Applicable: This is an AI/machine learning specific criterion. Dental cements do not have a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As above, no training set exists for this device.
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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
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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) 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 steelcrowns-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.
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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
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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, ProGlassNine, 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 withstainless 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.
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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
| DESCRIPTIVEINFORMATION | NEW DEVICENOVA GLASS CEMENTS (K210473) | PREDICATE DEVICEProGlass 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 crownsor orthodontic appliances retained withstainless 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 crownsor orthodontic appliances retained withstainless 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 androot surface caries-Core Build Up-Base/Liner | ProGlass Two LC-Class III and V restorations-Restoration of Cervical erosions androot surface caries-Core Build Up-Base/Liner | |
| Nova Glass BF-Class I & II cavities-Decidious teeth: final restorative forClass I, II and V-Long term restorative in non-loadbearing areas of Class I, II and V-Intermediate restorative & sandwichmaterial for heavy stress bearing-Core build up material | ProGlass Nine-Class I & II cavities-Decidious teeth: final restorative forClass I, II and V-Long term restorative in non-loadbearing areas of Class I, II and V-Intermediate restorative & sandwichmaterial for heavy stress bearing-Core build up material | |
| Nova Glass L Plus-Metal-based restorations-Ceramic inlays-Reinforced ceramic crowns andbridges-All kind of acrylic/resin crowns, inlays,onlays and bridges | ProGlass Plus-Metal-based restorations-Ceramic inlays-Reinforced ceramic crowns andbridges-All kind of acrylic/resin crowns, inlays,onlays and bridges | |
| FUNCTION | ||
| Nova Glass LLuting Cement | ProGlass OneLuting Cement | |
| Nova Glass FRestorative | ProGlass TwoRestorative | |
| Nova Glass LC | ProGlass Two LC |
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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 | ||||
|---|---|---|---|---|---|
| RestorativeBase/Liner | RestorativeBase/Liner | ||||
| Nova Glass L PlusLuting Cement | ProGlass PlusLuting Cement | ||||
| COMPOSITION | Nova Glass LPowder: Alumino-silicate glass, polyacrylic acidLiquid: Distilled water, polyacrylic acid | ProGlass OnePowder: Alumino-silicate glass, polyacrylic acidLiquid: Distilled water, polyacrylic acid | |||
| Nova Glass FPowder: Alumino-silicate glass, polyacrylic acidLiquid: Distilled water, polyacrylic acid | ProGlass TwoPowder: Alumino-silicate glass, polyacrylic acidLiquid: Distilled water, polyacrylic acid | ||||
| Nova Glass LCPowder: Alumino-silicate glassLiquid: Distilled water, polyacrylic acid, 2-hydroxyethyl methacrylate (HEMA), 2,2,4, Trimethyl hexamethylene dicarbonate (TMHMD) | ProGlass Two LCPowder: Alumino-silicate glassLiquid: Distilled water, polyacrylic acid, 2-hydroxyethyl methacrylate (HEMA), 2,2,4, Trimethyl hexamethylene dicarbonate (TMHMD) | ||||
| Nova Glass BFPowder: Alumino-silicate glass, polyacrylic acidLiquid: Polyacrylic acid, tartaric acid, distilled water | ProGlass NinePowder: Alumino-silicate glass, polyacrylic acidLiquid: Polyacrylic acid, tartaric acid, distilled water | ||||
| Nova Glass L PlusPowder: Alumino-silicate glassLiquid: Distilled water, polyacrylic acid, 2-Hydroxyethylmethacrylate, Urethanedimethacrylate | ProGlass PlusPowder: Alumino-silicate glassLiquid: 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. ●
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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.
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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.
§ 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.