Novidia Universal Bond

K183391 · Nobio , Ltd. · KLE · Sep 24, 2019 · Dental

Device Facts

• Record ID: K183391
• Device Name: Novidia Universal Bond
• Applicant: Nobio , Ltd.
• Product Code: KLE · Dental
• Decision Date: Sep 24, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Novidia Universal Bond is indicated for: 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.

Device Story

Resin-based dental bonding system; consists of self-etch primer and light-cured bond. Primer contains adhesion promoter/solvent; bond contains resin, solvent, initiators, and antibacterial insoluble particles (covalently bound quaternary ammonium). Used by dentists in clinical settings to enhance adhesion between mineralized dental surfaces (enamel/dentin) and restorative materials (composites, cements, metals, ceramics). Applied in two steps; light-cured at 430-490nm for 10 seconds. Provides antibacterial cavity cleansing effect for specific indications. Improves restoration retention and reduces hypersensitivity.

Clinical Evidence

Bench testing only. No clinical or animal data provided. Performance validated via ISO 10993 and ISO 7405 biocompatibility testing and bench tests including polymerization conversion degree, viscosity, shear bond strength (zirconia, glass ceramics, enamel, dentin, titanium, composite, amalgam), microleakage, and antibacterial activity. All tests met acceptance criteria.

Technological Characteristics

Resin-based, two-bottle system (self-etch primer and light-cured bond). Contains quaternary ammonium silica (QASi) for antibacterial properties. Curing wavelength 430-490nm; curing time 10 seconds. Biocompatibility per ISO 10993 and ISO 7405.

Indications for Use

Indicated for patients requiring direct composite/compomer restorations, cavity sealing for indirect restorations, treatment of hypersensitive teeth/exposed root surfaces, intraoral repair of fractured dental prosthetics (porcelain, hybrid ceramic, composite), core build-ups, and cavity sealing under amalgam. No specific age or gender restrictions.

Regulatory Classification

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.

Predicate Devices

• CLEARFIL™ Protect Bond (K023842, K033938)

Reference Devices

• 3M™ ESPE™ Adper™ Scotchbond™ multi-purpose (K920424, K942493)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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:

- 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.

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: [phone]

### Contact Person:

Shoshana (Shosh) Friedman Regulatory Affairs Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: [phone] [e-mail]

### 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:

- 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.

## 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:<br>Novidia Universal Bond | Primary Predicate Device:<br>Clearfil SE Protect Bond | Reference Device:<br>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-<br>cured composite resin or<br>compomer<br>2) Cavity sealing as a pretreatment<br>for indirect restorations<br>3) Treatment of hypersensitive teeth<br>and/or exposed root surfaces<br>4) Intraoral repairs of fractured<br>crowns/bridges made of porcelain,<br>hybrid ceramics, or composite<br>resin using light-cured composite<br>resin<br>5) Surface treatment of prosthetic<br>appliances made of porcelain,<br>hybrid ceramics, or cured<br>composite resin<br>6) Core build-ups using light- or<br>dual-cured composite resin<br>7) Cavity sealing under amalgam<br>restorations<br>** For indications 1, 2, 3, 6, and 7 the<br>device exhibits an antibacterial cavity<br>cleansing effect. | 1) Direct restorations using light-<br>cured composite resin or<br>compomer<br>2) Cavity sealing as a pretreatment<br>for indirect restorations<br>3) Treatment of hypersensitive<br>and/or exposed root surfaces<br>4) Intraoral repairs of fractured<br>crowns/bridges made of porcelain,<br>hybrid ceramics, or composite<br>resin using light-cured composite<br>resin<br>5) Surface treatment of prosthetic<br>appliances made of porcelain,<br>hybrid ceramics, or cured<br>composite resin<br>6) Core build-ups using light- or<br>dual-cured composite resin<br>7) Cavity sealing under amalgam<br>restorations<br>** For indications 1, 2, 3, 6, and 7 the<br>device exhibits an antibacterial cavity<br>cleansing effect. | Bonding all classes of direct<br>composite restorations as well as<br>bonding porcelain veneers, porcelain<br>and composite repairs with light cure<br>composite and bonding light cure<br>composite to amalgam. |
| Components | Primer and Bond | Primer and Bond | Etchant, Primer and Adhesive |
| Element | Subject Device:<br>Novidia Universal Bond | Primary Predicate Device:<br>Clearfil SE Protect Bond | Reference Device:<br>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 | Acceptance<br>Criteria | Novidia Universal Bond | Clearfil Protect Bond | 3M Adper Scotchbond |
|-------------------------------------|----------------|----------------------------------------------------------------------------------------------------|------------------------|-----------------------|---------------------|
| Polymerization<br>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:<br>0 (no penetration)<br>to 1 (only shallow<br>enamel surface<br>penetration). | Passed | Passed | Passed |
| Antibacterial Activity | | Reduction of the<br>viable 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.