(291 days)
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.
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).
The provided text describes the 510(k) premarket notification for the Novidia™ Universal Bond, a resin tooth bonding agent. It outlines the device's indications for use, its technical characteristics, and a comparison to predicate and reference devices. The core of the submission relies on bench testing to demonstrate substantial equivalence, rather than extensive clinical or human-in-the-loop studies commonly seen with AI/software as a medical device (SaMD).
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text, while noting the limitations in addressing all aspects of your request (particularly those related to AI/SaMD studies):
Acceptance Criteria and Reported Device Performance
Table 1: Acceptance Criteria and Novidia™ Universal Bond Performance
| Test | Acceptance Criteria | Novidia™ Universal Bond Performance |
|---|---|---|
| Polymerization Conversion Degree | $\ge 70%$ | Passed |
| Viscosity | $550 \pm 450 \text{ cP}$ | Passed |
| Shear Bond Strength (Zirconia) | $\ge 10 \text{ MPa}$ | Passed |
| Shear Bond Strength (Glass Ceramics) | (Implicitly $\ge 10 \text{ MPa}$ based on the Zirconia criterion being the general requirement for most materials) | Passed |
| Shear Bond Strength (Enamel) | (Implicitly $\ge 10 \text{ MPa}$ based on the Zirconia criterion being the general requirement for most materials) | Passed |
| Shear Bond Strength (Dentin) | (Implicitly $\ge 10 \text{ MPa}$ based on the Zirconia criterion being the general requirement for most materials) | Passed |
| Shear Bond Strength (Titanium) | (Implicitly $\ge 10 \text{ MPa}$ based on the Zirconia criterion being the general requirement for most materials) | Passed |
| Shear Bond Strength (Composite) | (Implicitly $\ge 10 \text{ MPa}$ based on the Zirconia criterion being the general requirement for most materials) | Passed |
| Shear Bond Strength (Amalgam) | $\ge 7 \text{ MPa}$ | Passed |
| Micro Leakage | Penetration levels: 0 (no penetration) to 1 (only shallow enamel surface penetration). | Passed |
| Antibacterial Activity | Reduction of the viable bacteria | Passed |
Note: The acceptance criteria for Shear Bond Strength for Glass Ceramics, Enamel, Dentin, Titanium, and Composite are not explicitly stated, but are implied to be $\ge 10 \text{ MPa}$ given the general structure of the table and the explicit criterion for Zirconia.
Study Details
The provided document describes a bench testing study to demonstrate substantial equivalence, rather than a clinical trial or AI model validation study.
-
Sample Size and Data Provenance for Test Set:
- The document does not specify the exact sample sizes used for each bench test (e.g., number of samples for polymerization conversion, viscosity, or shear bond strength). It only states that "Non-clinical and biological testing was completed."
- The data provenance is not explicitly mentioned in terms of country of origin or whether it was retrospective/prospective. As these are physical/chemical tests, data provenance in the context of geographical clinical data or time-based data collection methods (retrospective/prospective) is typically not applicable.
-
Number of Experts and Qualifications for Ground Truth:
- This is not applicable to this type of study. The ground truth for the performance of a dental bonding agent, in this context, is established through standardized laboratory procedures and measurements (e.g., ISO standards for bond strength, chemical analysis for polymerization conversion). Expert consensus, common in diagnostic AI, is not relevant here.
-
Adjudication Method for Test Set:
- Not applicable. Bench tests are objective measurements, not subjective evaluations requiring adjudication.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. The Novidia™ Universal Bond is a physical dental material, not an AI/SaMD.
-
Standalone Performance (Algorithm Only without Human-in-the-Loop):
- Not applicable in the AI/SaMD sense. The "performance" demonstrated is the physical and chemical properties of the material itself (e.g., bond strength, antibacterial activity) as measured in a lab, which is inherently "standalone" from a human interpretative loop.
-
Type of Ground Truth Used:
- The ground truth was established through objective laboratory measurements based on established scientific principles and potentially ISO standards for material testing (e.g., ISO 10993 for biocompatibility, ISO 7405 for dental materials). It's not expert consensus, pathology, or outcomes data as would be the case for a diagnostic AI.
-
Sample Size for Training Set:
- There is no mention of a training set because this is not an AI/machine learning device. The "training" for such a device would be the R&D and formulation process to develop the chemical composition and manufacturing procedures that yield the desired performance characteristics.
-
How the Ground Truth for the Training Set Was Established:
- As there is no "training set" in the AI sense, this question is not applicable. The development of the ground truth (i.e., the target performance characteristics) for the material would be based on dental material science, clinical needs, and performance of existing predicate devices.
In summary, the provided document details the regulatory pathway for a dental material (Novidia™ Universal Bond) based on substantial equivalence demonstrated through rigorous non-clinical, bench testing, and biocompatibility assessments, adhering to established industry standards for dental materials. It largely differs from the typical safety and effectiveness studies required for AI/Software as a Medical Device (SaMD) which often involve clinical data, human reader performance studies, and complex expert ground truth establishment.
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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
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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
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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)
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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
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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.
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| 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 orcompomer2) Cavity sealing as a pretreatmentfor indirect restorations3) Treatment of hypersensitive teethand/or exposed root surfaces4) Intraoral repairs of fracturedcrowns/bridges made of porcelain,hybrid ceramics, or compositeresin using light-cured compositeresin5) Surface treatment of prostheticappliances made of porcelain,hybrid ceramics, or curedcomposite resin6) Core build-ups using light- ordual-cured composite resin7) Cavity sealing under amalgamrestorations** For indications 1, 2, 3, 6, and 7 thedevice exhibits an antibacterial cavitycleansing effect. | 1) Direct restorations using light-cured composite resin orcompomer2) Cavity sealing as a pretreatmentfor indirect restorations3) Treatment of hypersensitiveand/or exposed root surfaces4) Intraoral repairs of fracturedcrowns/bridges made of porcelain,hybrid ceramics, or compositeresin using light-cured compositeresin5) Surface treatment of prostheticappliances made of porcelain,hybrid ceramics, or curedcomposite resin6) Core build-ups using light- ordual-cured composite resin7) Cavity sealing under amalgamrestorations** For indications 1, 2, 3, 6, and 7 thedevice exhibits an antibacterial cavitycleansing effect. | Bonding all classes of directcomposite restorations as well asbonding porcelain veneers, porcelainand composite repairs with light curecomposite and bonding light curecomposite 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
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| Test | AcceptanceCriteria | Novidia Universal Bond | Clearfil Protect Bond | 3M Adper Scotchbond | |
|---|---|---|---|---|---|
| PolymerizationConversion 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 shallowenamel surfacepenetration). | Passed | Passed | Passed | |
| Antibacterial Activity | Reduction of theviable bacteria | Passed | Passed | NA |
Table 5-2: Performance Comparison between Novidia Universal Bond, Clearfil Protect Bond and Adper Scotchbond
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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.
§ 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.