(291 days)
No
The device description and performance studies focus on the chemical composition and physical properties of a dental bonding agent. There is no mention of AI or ML in the intended use, device description, or performance testing sections.
No
The device is a bonding agent used in dental restorations and treatments. While it addresses hypersensitivity and cleanses cavities, its primary function is to enhance adhesion and facilitate restorative procedures, not to directly treat or cure a disease or condition as a therapeutic device would.
No
This device is a resin-based bond system designed to enhance adhesion between dental surfaces and restorative materials, and to provide antibacterial effects for various dental restorations and treatments. It is not used for diagnosing conditions or diseases.
No
The device description clearly states it is a "resin-based bond system consisting of a self-etch primer and a light-cured bond," detailing its chemical composition. This indicates a physical product, 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 are all related to dental procedures performed directly on the patient's teeth and oral structures (restorations, cavity sealing, treating hypersensitivity, repairing crowns/bridges, surface treatment of prosthetic appliances, core build-ups). These are therapeutic and restorative applications, not diagnostic tests performed on samples taken from the body.
- Device Description: The device is a resin-based bond system designed to enhance adhesion between dental surfaces and restorative materials. 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 IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
In summary, the Novidia Universal Bond is a dental material used in restorative and therapeutic procedures, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Novidia Universal Bond is indicated for:
-
- Direct restorations using light-cured composite resin or compomer
-
- Cavity sealing as a pretreatment for indirect restorations
-
- Treatment of hypersensitive teeth and/or exposed root surfaces
-
- Intraoral repairs of fractured crowns/bridges made of porcelain, hybrid ceramics, or composite resin using light-cured composite resin
-
- Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics, or cured composite resin
-
- Core build-ups using light- or dual-cured composite resin
-
- Cavity sealing under amalgam restorations
-
- For indications 1, 2, 3, 6, and 7 the device exhibits an antibacterial cavity cleansing effect.
Product codes
KLE
Device Description
Novidia™ Universal Bond is a resin-based bond system consisting of a self-etch primer and a light-cured bond. It is designed to enhance penetration into prepared enamel and dentin surfaces and to establish strong adhesion between mineralized dental surfaces and the restorative materials such as resin composites, resin cements, metals, and ceramics (e.g., porcelain, lithium disilicate, zirconia, or hybrid ceramics) restorations.
The chemical composition of the Universal Bond's primer consists of adhesion promoter and solvent, and the Universal Bond consists of resin, solvent, initiators and antibacterial insoluble particles, which contain covalently bound quaternary ammonium (QA).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dental
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: Non-clinical and biological testing was completed to assess the performance and biocompatibility of the Novidia™ Universal Bond and to support substantial equivalence. The data provided in this 510(k) submission shows that the bonding agent is biocompatible based on the biocompatibility assessment conducted as per ISO 10993 and ISO 7405 and performs as intended based on the bench testing.
Key Results:
- Polymerization Conversion Degree: Passed (≥ 70%)
- Viscosity: Passed (550 ± 450 cP)
- Shear Bond Strength: Passed (≥ 10 MPa for Zirconia, Glass Ceramics, Enamel, Dentin, Titanium, Composite; ≥ 7 MPa for Amalgam)
- Micro Leakage: Passed (Penetration levels: 0 (no penetration) to 1 (only shallow enamel surface penetration)).
- Antibacterial Activity: Passed (Reduction of the viable bacteria).
Animal and Clinical Performance Testing: Animal and clinical performance data was not included.
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
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
September 24, 2019
Nobio Ltd. % Shoshana (Shosh) Friedman Senior Regulatory Consultant Nobio [c/o ProMedoss, Inc.] 3521 Hatwynn Rd. Charlotte, North Carolina 28269
Re: K183391
Trade/Device Name: Novidia Universal Bond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: June 24, 2019 Received: June 26, 2019
Dear Shoshana (Shosh) Friedman:
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
1
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 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 (QS) 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 medical devices and radiation-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 Adjodha Acting 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) K183391
Device Name Novidia™ Universal Bond
Indications for Use (Describe)
Novidia Universal Bond is indicated for:
-
- Direct restorations using light-cured composite resin or compomer
-
- Cavity sealing as a pretreatment for indirect restorations
-
- Treatment of hypersensitive teeth and/or exposed root surfaces
-
- Intraoral repairs of fractured crowns/bridges made of porcelain, hybrid ceramics, or composite resin using light-cured composite resin
-
- Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics, or cured composite resin
-
- Core build-ups using light- or dual-cured composite resin
-
- Cavity sealing under amalgam restorations
-
- For indications 1, 2, 3, 6, and 7 the device exhibits an antibacterial cavity cleansing effect.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
K183391
510(K) SUMMARY [as required by section 807.92(c)] Novidia™ Universal Bond 510(k) Number K183391
5.1 SUBMITTER
Applicant's Name:
Nobio Ltd. 8 Hamatechet St. POB 50502 Kadima, Israel 6092000 Phone: +972-3-9059966
Contact Person:
Shoshana (Shosh) Friedman Regulatory Affairs Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: 704-430-8695 s.friedman@promedoss.com
Date Prepared:
January 3, 2019
5.2 DEVICE
Trade Name: Novidia™ Universal Bond
Name: Agent, Tooth Bonding, Resin Classification Code: Product Code: KLE Regulation No: 872.3200 Class: 2 Review Panel: Dental
5.3 PREDICATE DEVICE
- . Primary predicate device: CLEARFIL™ Protect Bond, manufactured by Kuraray Medical Inc., cleared under K023842 and K033938
- Reference device: 3M™ ESPE™ Adper™ Scotchbond™ multi-purpose, . manufactured by 3M Company, cleared under K920424 and K942493
5.4 DEVICE DESCRIPTION
Novidia™ Universal Bond is a resin-based bond system consisting of a self-etch primer and a light-cured bond. It is designed to enhance penetration into prepared
4
enamel and dentin surfaces and to establish strong adhesion between mineralized dental surfaces and the restorative materials such as resin composites, resin cements, metals, and ceramics (e.g., porcelain, lithium disilicate, zirconia, or hybrid ceramics) restorations.
The chemical composition of the Universal Bond's primer consists of adhesion promoter and solvent, and the Universal Bond consists of resin, solvent, initiators and antibacterial insoluble particles, which contain covalently bound quaternary ammonium (QA).
5.5 INDICATIONS FOR USE
Novidia™ Universal Bond is indicated for use in:
-
- Direct restorations using light-cured composite resin or compomer
-
- Cavity sealing as a pretreatment for indirect restorations
-
- Treatment of hypersensitive teeth and/or exposed root surfaces
-
- Intraoral repairs of fractured crowns/bridges made of porcelain, hybrid ceramics, or composite resin using light-cured composite resin
-
- Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics, or cured composite resin
-
- Core build-ups using light- or dual-cured composite resin
-
- Cavity sealing under amalgam restorations
** For indications 1, 2, 3, 6, and 7 the device exhibits an antibacterial cavity cleansing effect.
5.6 SUBSTANTIAL EQUIVALENCE
The Novidia Universal Bond has the same intended use and substantially similar technological characteristics as the Clearfil Protect Bond primary predicate device and its performance characteristics is substantially similar to both the Clearfil Protect Bond and the Adper Scotchbond reference device.
The general comparison between the Novidia Universal Bond, Clearfil Protect Bond and Adper Scotchbond are provided in Table 5-1 and the performance comparison between the devices are provided in Table 5-2 below.
5
| Element | Subject Device:
Novidia Universal Bond | Primary Predicate Device:
Clearfil SE Protect Bond | Reference Device:
3M Adper Scotchbond |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Nobio, Ltd. | Kuraray Medical, Inc. | 3M ESPE Dental Products |
| 510(k) Number | K183391 | K033938 | K942493 |
| Product Code | KLE | KLE | KLE |
| Indications for Use | 1) Direct restorations using light-
cured composite resin or
compomer
2) Cavity sealing as a pretreatment
for indirect restorations
3) Treatment of hypersensitive teeth
and/or exposed root surfaces
4) Intraoral repairs of fractured
crowns/bridges made of porcelain,
hybrid ceramics, or composite
resin using light-cured composite
resin
5) Surface treatment of prosthetic
appliances made of porcelain,
hybrid ceramics, or cured
composite resin
6) Core build-ups using light- or
dual-cured composite resin
7) Cavity sealing under amalgam
restorations
** For indications 1, 2, 3, 6, and 7 the
device exhibits an antibacterial cavity
cleansing effect. | 1) Direct restorations using light-
cured composite resin or
compomer
2) Cavity sealing as a pretreatment
for indirect restorations
3) Treatment of hypersensitive
and/or exposed root surfaces
4) Intraoral repairs of fractured
crowns/bridges made of porcelain,
hybrid ceramics, or composite
resin using light-cured composite
resin
5) Surface treatment of prosthetic
appliances made of porcelain,
hybrid ceramics, or cured
composite resin
6) Core build-ups using light- or
dual-cured composite resin
7) Cavity sealing under amalgam
restorations
** For indications 1, 2, 3, 6, and 7 the
device exhibits an antibacterial cavity
cleansing effect. | Bonding all classes of direct
composite restorations as well as
bonding porcelain veneers, porcelain
and composite repairs with light cure
composite and bonding light cure
composite to amalgam. |
| Components | Primer and Bond | Primer and Bond | Etchant, Primer and Adhesive |
| Element | Subject Device:
Novidia Universal Bond | Primary Predicate Device:
Clearfil SE Protect Bond | Reference Device:
3M Adper Scotchbond |
| Composition of Primer | Adhesive monomer carried in a water-ethanol solution | Adhesive monomer carried in a water-ethanol solution | Aqueous solution of HEMA and a polyalkenoic acid copolymer |
| Composition of Bond (Adhesive) | Matrices of hydrophilic, hydrophobic and amphiphilic nature | Matrices of hydrophilic, hydrophobic and amphiphilic nature | Matrices of hydrophilic, hydrophobic and amphiphilic nature |
| Antibacterial Component | Quaternary Ammonium Silica (QASi) | 12-methacryloyloxy-dodecyl-pyridinium-bromide (MDPB) | None |
| Mode of Use | Two-steps using two bottles of components, the first containing a self-etching primer and the second the bonding agent. | Two-steps using two bottles of components, the first contains a self-etching primer and the second contains the bonding agent. | Three-steps using three bottles, the first contains an etchant, the second contains a primer, and the third contains the bonding (adhesive) agent. |
| Self-Etching | Yes | Yes | No |
| Light-Cured | Yes | Yes | Yes |
| Curing Wavelength | 430-490nm | 400-515nm | Unknown |
| Curing Time | 10 seconds | 10 seconds | 10 seconds |
Table 5-1: General Comparison between Novidia Universal Bond, Clearfil Protect Bond and Adper Scotchbond
6
7
| | Test | Acceptance
Criteria | Novidia Universal Bond | Clearfil Protect Bond | 3M Adper Scotchbond |
|-------------------------------------|----------------|----------------------------------------------------------------------------------------------------|------------------------|-----------------------|---------------------|
| Polymerization
Conversion Degree | | $\u226570%$ | Passed | Passed | Passed |
| Viscosity | | $550\u00b1450 cP$ | Passed | Passed | Passed |
| Shear Bond Strength | Zirconia | $\u2265 10 MPa$ | Passed | Passed | Passed |
| | Glass Ceramics | | Passed | Passed | Passed |
| | Enamel | | Passed | Passed | Passed |
| | Dentin | | Passed | Passed | Passed |
| | Titanium | | Passed | Passed | Passed |
| | Composite | | Passed | Passed | Passed |
| | Amalgam | $\u2265 7 MPa$ | Passed | Passed | Passed |
| Micro Leakage | | Penetration levels:
0 (no penetration)
to 1 (only shallow
enamel surface
penetration). | Passed | Passed | Passed |
| Antibacterial Activity | | Reduction of the
viable bacteria | Passed | Passed | NA |
Table 5-2: Performance Comparison between Novidia Universal Bond, Clearfil Protect Bond and Adper Scotchbond
8
5.7 PERFORMANCE DATA
Non-Clinical Performance Testing:
Non-clinical and biological testing was completed to assess the performance and biocompatibility of the Novidia™ Universal Bond and to support substantial equivalence. The data provided in this 510(k) submission shows that the bonding agent is biocompatible based on the biocompatibility assessment conducted as per ISO 10993 and ISO 7405 and performs as intended based on the bench testing. The list of these tests is provided in Table 5-3.
| Biocompatibility |
|---|
| Cytotoxicity |
| Acute Systemic Toxicity |
| Direct Buehler Sensitization Test |
| Oral Irritation Test |
| Chemical Characterization |
| Material Mediated Pyrogenicity |
| Biological Risk Assessment |
| Bench Testing |
| Polymerization Conversion Degree |
| Viscosity |
| Shear Bond Strength |
| • Zirconia |
| • Glass Ceramics |
| • Enamel |
| • Dentin |
| • Titanium |
| • Composite |
| • Amalgam |
| Visual Inspection |
| Micro Leakage |
| Antibacterial Activity |
Table 5-3: List of Tests Completed on Novidia Universal Bond
Animal and Clinical Performance Testing:
Animal and clinical performance data was not included.
5.8 CONCLUSION
Nobio Ltd. believes that Novidia™ Universal Bond is substantially equivalent to the Clearfil Protect Bond primary predicate device and the 3M Adper Scotchbond reference device. It does not introduce new indications for use, has substantially equivalent technological and performance characteristics, and therefore does not introduce any new safety or effectiveness concerns.