(462 days)
No
The device description and performance studies focus on the chemical composition and physical properties of a dental adhesive, with no mention of AI or ML.
No.
The device is an adhesive used in dental restorations and for treating hypersensitive teeth, which is a supportive rather than a therapeutic function.
No
The device is an adhesive used for dental restorations and treatments, not for diagnosing conditions. Its intended uses involve bonding materials to teeth or treating surfaces, which are therapeutic/restorative functions.
No
The device description clearly indicates it is a physical chemical substance (adhesive) used in dental procedures, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to dental procedures performed directly on the patient's tooth structure (restorations, sealing, treatment of surfaces, repairs, cementation). These are therapeutic and restorative actions, not diagnostic tests performed on samples taken from the body.
- Device Description: The description details a dental adhesive used to bond materials to tooth structure. This is a material used in a clinical procedure, not a reagent or instrument used to analyze a biological sample for diagnostic purposes.
- Lack of Diagnostic Function: There is no mention of this device being used to detect, measure, or analyze any substance or characteristic in a biological sample (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on bond strength, curing time, and appearance – properties relevant to its function as a dental adhesive in a clinical setting, not diagnostic accuracy metrics like sensitivity or specificity.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used in vivo (within the body) as part of a dental treatment.
N/A
Intended Use / Indications for Use
-
- Direct restorations using light-cured composite resin
-
- Cavity sealing as a pretreatment for indirect restorations
-
- Treatment of exposed root surfaces
-
- Treatment of hypersensitive teeth
-
- Intraoral repairs of fractured restorations
-
- Post cementation and core build-ups
-
- Cementation of inlays, onlays, crowns, bridges and veneers
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
R&D Series Nova Compo- B Plus is a Light-cure ethanol/water-based, self-etching, one-step, all in one universal adhesive. It can be used reliably in total-etch or selective-etch mode for both direct and indirect restorations. Depending on the indication, the adhesive is used as self-etching or with phosphoric acid for selective enamel etching procedures. The product is intended to be used for both direct and indirect restorations. The 4-MET RDX multi-functional carboxylate methacrylate polymer creates a 3-dimensional, high-strength bond with calcium. MDP (Methacryloyloxydecyl Dihydrogen Phosphate) monomer binds to Ca+2 ions on all surfaces of the tooth. The R&D Series Nova Compo- B Plus forms a micro-mechanical bond between the dentine channels to form the resin tags. Depending on the indication, the adhesive is used as self-etching or with phosphoric acid for selective enamel etching or total-etching procedures.
This is the new registration application for the subject device and there have not been any prior submissions regarding the subject device and there have not been any prior submissions regarding the subject device.
The product is sold in 5 ml bottles or 50x0.1 ml capsule.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth/teeth, dentin, enamel
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:
In accordance with 10993-1 (Biological Assessment Medical Devices- Part1:Evaluation and Testing) and ISO 7405 (Dentistry – Biocompatibility of Medical Devices used in Dentistry) standards, biocompatibility was evaluated for R&D Series Nova Compo-B Plus all in one universal adhesive.
Results:
- Cytotoxicity: After 24 hours, severe (+4) degree of biological reactivity was observed.
- Sensitization: Does not cause hypersensitive skin reaction.
- Skin Irritation: Does not cause skin irritation.
- Acute Systemic Toxicity: Does not have acute systemic toxic effects.
- Subacute Systemic Toxicity: Does not have subacute systemic toxic effects.
- Genotoxicity: Does not have genotoxic potential.
- Implantation: According to local effect categories after implantation for rabbit, "mild irritation was found to be effective."
Physical Properties: In vitro bench tests were performed on the R&D Series Nova Compo-B Plus all in one universal adhesive according to the requirements in ISO 29022:2013 Dentistry-Adhesion-Notched-edge shear bond strength test.
Bench tests included:
- Appearance: Homogenous and free from foreign matters
- Curing Time: 10 second
- Bond strength to tooth structure: >10 MPa for enamel, >10 MPa for dentin
- Bond strength to metal: >10 MPa for precious metal, >10 MPa for non-precious metal
- Bond strength to ceramic and composite: >10 MPa for porcelain, >10 MPa for composite, >10 MPa for zirconia
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the U.S. Food & Drug Administration logo is on the right. The FDA logo is in blue and white.
January 19, 2021
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. Husamettin Sonmez General Manager Fetih Mahallesi Mahir Sokak No:5/201 Konya, 42030 TURKEY
Re: K192913
Trade/Device Name: R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: December 15, 2020 Received: December 21, 2020
Dear Husamettin Sonmez:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192913
Device Name R&D Series Nova Compo-B Plus
Indications for Use (Describe)
-
- Direct restorations using light-cured composite resin
-
- Cavity sealing as a pretreatment for indirect restorations
-
- Treatment of exposed root surfaces
-
- Treatment of hypersensitive teeth
-
- Intraoral repairs of fractured restorations
-
- Post cementation and core build-ups
-
- Cementation of inlays, onlays, crowns, bridges and veneers
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image is a logo for IMICRYL, a dental materials company. The logo features the company name in large, bold, blue letters, with the registered trademark symbol to the right of the name. To the left of the name is a blue circle with the letters "IMI" inside. Below the company name is the phrase "DIŞ MALZEMELERI SAN. VE TIC A.Ş." in smaller, blue letters.
K192913
510(k) Summary
R&D Series Nova Compo-B Plus ®
All in One Universal Adhesive
Date of Summary Preparation: September 05, 2019
Type of Submission: Traditional 510(k)
Submitter Information:
Company Name: IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
Company Address: Fetih Mahallesi Mahir Sokak No:5/201 Zip Code:42030 Karatay/Konya/TURKEY
Phone Number: 0090 444 71 30
Fax Number: 0090 332 355 76 19
Contact Person: Husamettin SONMEZ
Phone: 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: R&D Series Nova Compo-B Plus
Common Name: Dental Bonding Agent
Product Code: KLE
Classification Class: II
Classification Name: Resin Tooth Bonding Agent
Regulation Number: 872.3200
Review Panel: Dental
4
Predicate and Reference Devices:
R&D Series Nova Compo-B Plus all in one universal adhesive is substantially equivalent to
the following marketed products:
| COMPANY | DEVICE | 510(k) NUMBER | PRODUCT CODE | DESCRIPTIVE
INFORMATION | NEW DEVICE/
R&D SERIES NOVA COMPO
B PLUS | REFERENCE DEVICE/
G-Premio BOND
(K143140) | PREDICATE DEVICE/
Clearfil Universal Bond
(K132450) |
|------------------------------|-----------------------------------------------|---------------|--------------|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| GC America Inc. | G-Premio BOND
(Reference Device) | K143140 | KLE | INDICATION FOR USE | | | |
| Kuraray Noritake Dental Inc. | CLEARFIL Universal Bond
(Predicate Device) | K132450 | KLE | COMPOSITION | 1. Direct restorations
using Light-cured
composite resin
2. Cavity sealing as a
pretreatment for
indirect restorations
3. Treatment of exposed
| 1. Bonding of light cured
composites and acid
modified composites
(compomers) to tooth
structure.
2. Bonding of dual cured
luting and core build up
composites to tooth
structure as long as these
materials are light cured.
3. Intraoral repairs of
porcelain fused to metal
crowns and composite
veneer crowns with
metal backing.
4. Intraoral repairs of all
ceramic crowns (except
zirconia and alumina),
hybrid resin jacket
crowns, CAD/CAM hybrid
resin crowns and
composites.
5. Intraoral repairs of
porcelain fused to
zirconia crowns,
porcelain fused to
alumina crowns and full
zirconia crowns.
6. Treatment of
hypersensitive teeth. | 1. Direct restorations
using light-cured
composite resin
2. Cavity sealing as a
pretreatment for
indirect restorations
3. Treatment of
exposed root
surfaces
4. Treatment of
hypersensitive teeth
5. Intraoral repairs of
fractured
restorations
6. Post cementation
and core build-ups
7. Cementation of
inlays, onlays,
crowns, bridges and
veneers |
Indication for Use:
-
- Direct restorations using light-cured composite resin
-
- Cavity sealing as a pretreatment for indirect restorations
-
- Treatment of exposed root surfaces
-
- Treatment of hypersensitive teeth
-
- Intraoral repairs of fractured restorations
-
- Post cementation and core build-ups
-
- Cementation of inlays, onlays, crowns, bridges and veneers
Device Description:
R&D Series Nova Compo- B Plus is a Light-cure ethanol/water-based, self-etching, one-step, all in one universal adhesive. It can be used reliably in total-etch or selective-etch mode for both direct and indirect restorations. Depending on the indication, the adhesive is used as self-etching or with phosphoric acid for selective enamel etching procedures. The product is intended to be used for both direct and indirect restorations. The 4-MET RDX multi-functional carboxylate methacrylate polymer creates a 3-dimensional, high-strength bond with calcium. MDP (Methacryloyloxydecyl Dihydrogen Phosphate) monomer binds to Ca+2 ions on all surfaces of the tooth. The R&D Series Nova Compo- B Plus forms a micro-mechanical bond between the dentine channels to form the resin tags. Depending on the indication, the adhesive is used as self-etching or with phosphoric acid for selective enamel etching or total-etching procedures.
This is the new registration application for the subject device and there have not been any prior submissions regarding the subject device and there have not been any prior submissions regarding the subject device.
The product is sold in 5 ml bottles or 50x0.1 ml capsule.
Substantial Equivalence:
The applicant device has the same intended use as the 510(k) cleared predicates listed above.
Table 1 below shows a comparison of R&D Series Nova Compo-B Plus all in one universal adhesive and the predicate and reference devices.
5
6
| PHYSICAL PROPERTIES | Hydrophilic aliphatic dimethacrylate 2 hydroxyethyl methacrylate (HEMA) Bis-GMA MDP monomer (10-Methacryloyloxy decyl dihydrogen phosphate) 4- MET RDX multi-functional carboxylate methacrylate polymer Silane Ethanol Water Highly dispersed silicon dioxide (10%) dl-camphoroquione Stabilizers | Acetone 2-Hydroxy-1,3 dimethacrylaxypropane 10-Methacryloyloxydecyl dihydrogen phosphate (MDP) 2,2-ethylenedioxydiethyl dimethacrylate Diphenyl (2,4,6 trimethylbenzoyl) phosphine oxide 4- MET RDX multi-functional carboxylate methacrylate polymer dl-camphoroquione 2,6 di-tert-butyl-p-cresol(Stabilizers) | 10-Methacryloyloxydecyl dihydrogen phosphate (MDP) Bisphenol A diglycidylmethacrylate (Bis-GMA) 2-Hydroxyethyl methacrylate (HEMA) Hydrophilic aliphatic dimethacrylate Colloidal silica 4- MET RDX multi-functional carboxylate methacrylate polymer Silane coupling agent dl-Camphorquinone Ethanol Water Stabilizers |
|---|---|---|---|
| Appearance | Homogenous and free from foreign matters | Homogenous and free from foreign matters | Homogenous and free from foreign matters |
| Curing Time | 10 second | 10 second | 10 second |
| Bond strength to tooth | >10 MPa for enamel | >10 MPa for enamel | >10 MPa for enamel |
| structure | >10 MPa for dentin | >10 MPa for dentin | >10 MPa for dentin |
| Bond strength to metal | >10 MPa for precious metal | >10 MPa for precious metal | >10 MPa for precious metal |
| >10 MPa for non-precious metal | >10 MPa for non-precious metal | >10 MPa for non-precious metal | |
| Bond strength to ceramic and | >10 MPa for porcelain | >10 MPa for porcelain | >10 MPa for porcelain |
| composite | >10 Mpa for composite | >10 Mpa for composite | >10 Mpa for composite |
| >10 MPa for zirconia | >10 MPa for zirconia | >10 MPa for zirconia |
7
Similarities
- The intended uses of the subject device were written up based on those of CLEARFIL UNIVERSAL BOND. Therefore, the intended uses of the subject device are substantially equivalent to those of the predicate devices.
- Products; they are substantially equivalent in terms of their physical properties.
- . The specifications that are important to determine substantial equivalency of a dental adhesive system are bond strengths associated to enamel and dentin (tooth structure). The bond strengths as noted above compare the predicate device to the new device. In both enamel and dentin bonding, the results were equivalent.
- . Due to its similarity in the G-Premio Bond formulation, it is the reference device of R&D Series Nova Compo B Plus.
- All ingredients in the subject have been used in the predicate devices. Regarding the predicate devices, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US. Accordingly, it was concluded that the safety of the subject device was substantially equivalent to that of the predicate devices.
- As the result of the testings, it was confirmed that the performance of the subject device was not significantly different or not less than that of the predicate devices.
Differences
- . Even if it seems like a difference; The Colloidal silica contained in Kuraray Clearfil Universal Bond is the same as our highly dispersed silicon dioxide (10%) contain.
- . Clearfil Universal Bond and R & D Series Nova Compo-B plus products use ethanol as a solvent, while Acetone is used in G-Premio products. Ethanol and acetone are being used as a solvent in the bonding agents. Before light curing the bonding agent, the solvent is evaporated with air by dentist. The solvent does not affect the adhesive strength of the bonding agents because it is removed during application.
- Clearfil Universal Bond and R & D Series Nova Compo-B plus products use META as a monomer, G-Premio use 2-Hydroxy-1,3 dimethacrylaxypropane. These monomers are similar monomers.
- Clearfil Universal Bond and R & D Series Nova Compo-B Plus products do not require primers in ceramic restorations because they contain silane, but because G-Premio does not contain silane, they require primers in ceramic restorations.
Non-Clinical Performance Testing:
Biocompatibility Testing:
In accordance with 10993-1 (Biological Assessment Medical Devices- Part1:Evaluation and Testing) and ISO 7405 (Dentistry – Biocompatibility of Medical Devices used in Dentistry) standards, biocompatibility was evaluated for R&D Series Nova Compo-B Plus all in one universal adhesive. The biocompatibility data for R&D Series Nova Compo-B Plus all in one universal adhesive are given in the table below.
8
| TEST NAME | RESULT |
|---|---|
| Cytotoxicity | After 24 hours, severe (+4) degree of biological reactivity was observed. |
| Sensitization | Does not cause hypersensitive skin reaction. |
| Skin Irritation | Does not cause skin irritation. |
| Acute Systemic Toxicity | Does not have acute systemic toxic effects. |
| Subacute Systemic Toxicity | Does not have subacute systemic toxic effects. |
| Genotoxicity | Does not have genotoxic potential. |
| Implantation | According to local effect categories after implantation for rabbit, "mild irritation was found to be effective." |
The subject device is categorized into the external communicating device (tissue/bone/dentin) and permanent contact device.
All the chemical ingredients of the subject device are equivalent to those of the predicate devices. Regarding the predicate devices, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US.
Accordingly, it was concluded that the subject device was substantially equivalent in safety to the predicate devices.
Physical Properties:
In vitro bench tests were performed on the R&D Series Nova Compo-B Plus all in one universal adhesive according to the requirements in ISO 29022:2013 Dentistry-Adhesion-Notched-edge shear bond strength test.
Bench tests included in support of the substantial equivalence of R&D Series Nova Compo-B Plus all in one universal adhesive are:
- Appearance
- Curing Time
- Bond Strength to Tooth Structure
- Bond Strength to Metal
- . Bond Strength to Ceramic and Composite
Technological Characteristics:
The chemical composition of the subject device is such that it can bond to tooth surfaces as well as composites, hybrid ceramics, ceramics and metals.
Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this premarket notification, IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. concludes that the R&D SERIES NOVA COMPO-B PLUS all in one universal adhesive is safe, effective and substantially equivalent to the predicate device and reference device as described herein. It does not introduce new indications for use, has similar technological characteristics and does not introduce new potential hazards or risks.