(85 days)
Evadyne® is a light cured single-component material for the temporary restoration of crowns, bridges, or similar dental prostheses. Evadyne is intended for the general dental patient population.
NeoDental Chemical Products, Inc, (NeoDental) wishes to submit their Evadyne® Temporary Crown and Bridge Resin for 510(k) clearance. Evadyne®, (shown in Figure 1) is a yellowish translucent, light-cured temporary restoration material for direct filling. After curing, Evadyne can be removed in one piece when the permanent restoration is to be placed. Evadyne® is packaged as a multiple use syringe, with new tips being attached for each patient. The syringe can be used until empty. The syringe is kept capped between uses and is fitted with a new tip just prior to use. The syringe is cleaned with an alcohol wipe before and after use.
The provided document is a 510(k) Summary for a dental device called "Evadyne Temporary Crown and Bridge Resin". It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the format requested (e.g., diagnostic accuracy metrics like sensitivity, specificity, or AUC).
Instead, the document focuses on:
- Device Description and Intended Use: Explaining what the Evadyne resin is and how it's used.
- Substantial Equivalence to a Predicate Device: Comparing Evadyne to Fermit-N (K934978) based on intended use, indications, and technological characteristics. The argument for substantial equivalence relies on them having similar applications, mechanisms of polymerization, and general properties, while acknowledging some differences in composition, flow, and flexural strength.
- Non-Clinical Test Data (Biocompatibility): This section details the biocompatibility evaluation, primarily through referencing recognized consensus standards (ISO 10993-1) and listing specific biological tests conducted (Cytotoxicity, Sensitization, Genotoxicity, Irritation) in 2001-2002 by Covance Lab. It also mentions that the main ingredient (UDMA) and filler (fluoroaluminosilicate glass) are widely used and have a history of safe use, and that 76,000 units have been sold since 2005 without reported incidents.
- Claims of Equivalence, not Performance Targets: The document concludes that Evadyne is "substantially equivalent" to the predicate device, not that it meets specific quantitative performance targets or acceptance criteria in a comparative study against a pre-defined threshold.
Therefore, I cannot populate the requested table or answer most of the questions because the necessary information (acceptance criteria, device performance metrics, study design for accuracy, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance data) is not present in the provided text.
The closest information related to "acceptance criteria" is the device's conformance to biocompatibility requirements according to ISO 10993-1 and the fact that "Results were found to conform to requirements (see section 15)," but the specific numerical acceptance criteria for these biological tests are not detailed here. The "reported device performance" is simply the claim of being "substantially equivalent" and having an uneventful safety record over several years.
Summary of what cannot be provided from the text:
- Table of acceptance criteria and reported device performance: Not available. The document discusses "substantially equivalent" to a predicate, and conformance to biocompatibility standards, but no quantitative performance metrics or specific acceptance criteria are listed.
- Sample size for the test set and data provenance: Not applicable as it's not a performance study measuring accuracy. Biocompatibility tests would have their own sample sizes (e.g., guinea pigs for sensitization), but these are not for device performance against a diagnostic target.
- Number of experts used to establish ground truth & qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not conducted or reported.
- Standalone performance study: No such study described or reported.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable (no AI/ML involved).
- How ground truth for the training set was established: Not applicable.
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SEP - 7 2011
Section 005 - Traditional 510(k) Summary
As required in 21 CFR807.92, we hereby submit this 510(k) Summary.
510(k) owners name, address, phone, fax, contact person & preparation date
The 510(k) owner is NeoDental Chemical Products Co., Ltd.
3-1-3 Hiroo, Shibuyaku, Tokyo, Japan 150.
Phone - 3 (3400) 3768,
Fax - 3 (3499) 0613.
The contact person is Mr. Nobuki Ishikawa, Treasurer, NeoDental International, Inc.
510(k) preparation date - 28 May 2011
SUBJECT DEVICE:
Name of the device, trade name, proprietary name, and classification name
Trade name: Evadyne Temporary Crown and Bridge Resin
Common name: Temporary Crown and Bridge Resin
Classification name: Crown and Bridge, Temporary, Resin (21 CFR 872.3770, Product Code EBG).
Device Description:
NeoDental Chemical Products, Inc, (NeoDental) wishes to submit their Evadyne® Temporary Crown and Bridge Resin for 510(k) clearance.
Evadyne®, (shown in Figure 1) is a yellowish translucent, light-cured temporary restoration material for direct filling. After curing, Evadyne can be removed in one piece when the permanent restoration is to be placed.
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Image /page/1/Picture/0 description: This image shows a world map. The map is a simple outline of the continents and major landmasses. The map appears to be a black and white image, with the landmasses outlined in black and the oceans in white.
Figure 1
Image /page/1/Picture/3 description: The image shows a box of Bixodyne dental syringes and one syringe outside of the box. The box is a dark color with the word "Bixodyne" printed on it in a lighter color. The syringe is silver with a black plunger and a small, curved needle. The syringe is sitting on top of a small piece of paper.
Image /page/1/Picture/4 description: The image shows a black and white illustration of a syringe. The syringe has a long, cylindrical body with a plunger on one end and a needle on the other. The needle is curved and has a sharp point. There are two handles on the side of the syringe. The syringe appears to be made of metal.
Image /page/1/Figure/5 description: The image shows the text "Figure 2 - Syringe". The text is in a sans-serif font and is left-aligned. The words "Figure" and "Syringe" are capitalized, and the number "2" is present.
Evadyne® is packaged as a multiple use syringe, with new tips being attached for each patient. The syringe can be used until empty. The syringe is kept capped between uses and is fitted with a new tip just prior to use. The syringe is cleaned with an alcohol wipe before and after use.
Indication for Use:
Evadyne® is a light cured single-component material for the temporary restoration of crowns, bridges, or similar dental prostheses. Evadyne is intended for the general dental patient population.
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Intended Use:
Evadyne® is a light cured, single-component material for temporary restoration. Evadyne® is easily expressed through the plunger type syringe and the low viscosity paste allows for direct filling. The product is delivered directly into the prepared cavity using single-use, disposable tips. Evadyne is a tasteless, odorless restoration, provides good sealing and can be easily removed when the permanent restoration is to be placed.
The Indications for Use and Intended Use information for the predicate product are equivalent and are reproduced below:
PREDICATE DEVICE:
The legally marketed predicate for the Evadyne® Temporary Crown and Bridge Resin is Fermit-N, (K934978), a light-curing temporary filling material produced by IvoClar N.A., Inc.
Indications for Use: Temporary restoration material
Intended Use: - Temporary restorations in the inlay/onlay technique for temporary restorations of all kinds. Relining material for prefabricated temporary crowns and bridges made of polycarbonate or methacrylates.
As is documented in the comparison of Indications For Use and Intended Use, the Evadyne® temporary bridge and crown resin and the Fermit N temporary bridge and crown resin are indicated for the same use, share the same clinical indication, clinical setting, target population, anatomical sites, intended use, prescription requirement, storage conditions and method of application.
Technological characteristics - Evadyne® versus the predicate device
A technical comparison of the subject device to the predicate device is detailed in the Substantial Equivalence discussion below (see the comparison table below).
Both Evadyne® and Fermit N are indicated for the same use. Evadyne was designed, tested and compared to Fermit N.
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Image /page/3/Picture/0 description: This image shows a world map. The map is a simple outline of the continents and islands. The continents are North America, South America, Europe, Africa, Asia, and Australia. The islands are Greenland, Iceland, Japan, and New Zealand. The map is a simple representation of the world.
Similarities: Evadyne is substantially equivalent to the predicate device in:
- Device description, ●
- Intended use, ●
- Indication for use, .
- Requirement for prescription use, ●
- Storage conditions, .
- Mechanism of polymerization (light polymerized) .
- . Container/closure
Differences: There are slight differences between the Fermit N product and Evadyne.
- . Composition - Evadyne uses a fluoroaluminosilicate glass as a filler. Fermit uses a co-polymer. Both of these compounds are used to maintain the properties of the filling material.
- Flow, flexural strength, and syringe type differ due to Evadyne is formulated to . have a lower viscosity for better ease of use (application directly to the prepared cavity from the syringe). The lower viscosity also results in Evadyne having a lower flexural strength relative to Fermit N.
We conclude that for all significant parameters, Evadyne is substantially equivalent to Fermit N. These include the photocatalytic material and mechanism, intended use, indication for use, most physical properties, design, packaging and performance.
Non clinical test data:
The Evadyne® temporary crown and bridge resin has been evaluated according to recognized consensus standards defined in ISO 10993-1. Results were found to conform to requirements (see section 15). Test data is further discussed in Section 15.
21 CFR 872.3770 lists the following recognized consensus standards:
- ANSI/ADA Specification No. 53 Polymer-Based crowns and Bridge Resins; . 1999/2005.
- . ANSI/ADA Specification No. 80 - Dental Materials - Determination of Color Stability 2001/2007.
- ISO 10477:2004 Dentistry Polymer-based crown and bridge materials .
- ISO 7405:2008 Evaluation of biocompatibility of medical devices used in dentistry. .
However, NeoDental believes that these tests are not relevant for the following reasons:
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- Evadyne is a TEMPORARY FILLING material for cavities. Physical properties have evaluated according to ISO 4049, but the other tests required in ISO-4049 are not applicable to Evadyne for the following reasons:
- o ISO-10477 is for crown bridge cement. The tests relating to Evadyne are same as ISO 4049.
- ANSI Spec 53 is identical to ISO-10477 o
- ANSI Spec 80 is for color stability of products which are to be applied to o permanent restorations having color shadings.
Biocompatibility of Evadyne
According to ISO 10993-1 Annex A, Evadyne can be categorized as shown Table 1.
Table 1
| Medical device categorization by | Biological effect forconsideration | ||
|---|---|---|---|
| Nature ofbody contact | Category | External communicatingdevice | - Cytotoxicity |
| - Sensitization | |||
| Contact | Tissue/bone/dentin | ||
| Contact duration | B (>24 h to 30 days) | - Systemic toxicity | |
| - Subchronic toxicity | |||
| - Genotoxicity | |||
| - Implantation |
< Biological evaluation >
Urethane resin (UDMA), main ingredient of Evadyne, has been widely used in dental restorative materials as a "composite resin". Additionally, fluroaluminosilicate glass, an ingredient of Evadyne, has been widely used in composite filling materials.
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.
According to ISO 10993-1, the systematic approach to a biological evaluation for Evadyne is as follows.
| Start |
|---|
| ↓ |
| Is there either direct or indirect contact? |
| yes |
| ↓ |
| Is the material same as in commercially available device? |
| yes |
| ↓ |
| Dose the device have the same chemical composition? |
| yes |
| ↓ |
| Are the manufacturing and the sterilization the same? |
| yes |
| ↓ |
| Is the body contact the same? |
| yes |
| ↓ |
| Perform biological evaluation (Annex A) |
| Biological evaluation complete |
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Table 2
| Biological test | Date/Test house | Method |
|---|---|---|
| Cytotoxicity | 2002.9.18/CovanceLab. | Agar Overlay Assay |
| Sensitization | 2002.9.12/CovanceLab. | Maximization method /Guinea Pig |
| Genotoxicity | 2002.9.16/CovanceLab. | Bacterial strain: (TA98,TA100, TA1535, TA1537,WP2uvrA)S9+ & S9- method |
| Irritation | 2001.9.27 /In vitrointer-national | Irritation Assay System(Ocular irritation testmethod) |
NeoDental did not conduct the biological tests for systemic toxicity, subchronic toxicity and implantation. Testing conducted and the long-use of this product has demonstrated safety for its intended use. Total Evadyne sales equal 76,000 sets from 2005 until now. No incidents or adverse events have been reported since 2005. Furthermore, Evadyne holds the CE mark which was renewed in October 2010.
Summary
NeoDental concludes that Evadyne is substantially equivalent to the predicate device in characteristics and technology.
End of 510(k) Summary Section
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Neodental Chemical Products Company. Limited C/O Mr. Robert Seiple. MPM, RAC Senior Consultant Emergo Global Consulting, LLC 611 West 3" Street Austin, Texas 78701
- 7 2011
Re: K111666
Trade/Device Name: Evadyne® Temporary Crown and Bridge Resin Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: June 13. 2011 Received: June 14, 2011
Dear Mr. Seiple:
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. 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.
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Page 2- Mr. Seiple
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology. General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 004 - Indication for Use
| INDICATIONS FOR USE STATEMENT | |
|---|---|
| 510(k) Number (if known): | K111666 |
| Device Name: | Evadyne® Temporary Crown and Bridge Resin |
Indications for Use:
Evadyne® is a light cured single-component material for the temporary restoration of crowns, bridges, or similar dental prostheses. Evadyne is intended for the general dental patient population.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Kunon
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.