OptiBond eXTRa Universal

K182162 · Kerr Corporation · KLE · Nov 7, 2018 · Dental

Device Facts

• Record ID: K182162
• Device Name: OptiBond eXTRa Universal
• Applicant: Kerr Corporation
• Product Code: KLE · Dental
• Decision Date: Nov 7, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Resin tooth bonding agent used in direct and indirect bonding applications

Device Story

OptiBond eXTRa Universal is a two-component dental adhesive system comprising a primer and an adhesive. The primer etches enamel and dentin; the adhesive is 15% filled with 0.4-micron barium glass to reinforce bond strength. Used by licensed dental professionals in clinical settings for direct and indirect restorative procedures. The system facilitates adhesion to tooth structure and restorative materials via micro-mechanical interlocking and chemical bonding. It is compatible with self-etch, total-etch, and selective-etch techniques. The clinician applies the primer to the tooth surface, followed by the adhesive, which is then light-cured. This process secures restorations, repairs, or posts, benefiting patients by providing durable, stable dental restorations and reducing sensitivity.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including shear bond strength testing to various substrates (enamel, dentin) and biocompatibility testing per ISO 10993 standards.

Technological Characteristics

Two-component resin bonding system (primer and adhesive). Adhesive contains 0.4-micron barium glass filler (15% w/w). Chemistry includes methacrylate and GPDM monomers. Curing via photo-initiation. Compatible with self-etch, total-etch, and selective-etch techniques. Biocompatibility per ISO 10993-1, -3, -5, -6, -10. Adhesion testing per ISO 29022:2013.

Indications for Use

Indicated for direct bonding applications including light-cured composite and compomer restorations, composite/ceramic/metal repairs, cavity sealing for amalgam restorations, sealing of hypersensitive/exposed root surfaces, and core build-ups. Indicated for indirect bonding applications including veneers, resin cements and core buildup materials, porcelain/ceramic/composite/metal-based inlays/onlays/crowns/bridges, endodontic posts, and cavity sealing as a pretreatment for indirect restorations.

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

• OptiBond XTR (K101423)

Submission Summary (Full Text)

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November 7, 2018

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the words "U.S. Food & Drug Administration" on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the words in a sans-serif font.

Kerr Corporation % Ardrena Jackson Senior Regulatory Affairs Specialist Sybron Dental Specialties 1717 W. Collins Ave Orange, California 92867

Re: K182162

Trade/Device Name: OptiBond eXTRa Universal Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: August 8, 2018 Received: August 10, 2018

Dear Ardrena Jackson:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Digitally signed by Mary S. Runner -S3 Mary S. Runner -S3 12:56:12 -05'00' For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below

510(k) Number (if known) K182162

Device Name OptiBond eXTRa Universal

Indications for Use (Describe)

Direct Bonding Applications

- · Light-cured composite and compomer restorations.
- · Composite/ceramic/metal repairs.
- · Cavity sealing for amalgam restorations.
- · Sealing of hypersensitive and/or exposed root surfaces.
- · Core build-ups (self-cured, light-cured, or dual-cured).

## Indirect Bonding Applications

- · Veneers.
- · Self-cure, dual-cure, light-cure resin cements and core buildup materials.
- · Porcelain, ceramic (including zirconia-based, lithium disilicate-based and alumina-based), composite, and metal-based (including precious and non-precious metal inlays, onlays, crowns, bridges.

• Endodontic posts.

- · Cavity sealing as a pretreatment for indirect restorations.
Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 510K K182162

Image /page/3/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo consists of the letters "sds" in a stylized font, with a curved line above the letters. Below the letters, the words "Sybron Dental Specialties" are written in a smaller font. The logo is simple and professional, and it is likely used to represent the company's brand.

# OptiBond eXTRa Universal

- 1. Submitter Information: Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687

| Contact Person: | Ardrena Jackson |
|-------------------|-----------------|
| Telephone Number: | 714-516-7491 |
| Fax Number: | 909-962-5694 |
| Date Prepared: | August 8, 2018 |

- 2. Device Name:

| Classification Name | Resin tooth bonding agent |
|---------------------|---------------------------|
| FDA CDRH Panel | Dental |
| Product Code | KLE |
| Regulation Number | 872.3200 |
| Class # | II |

- 3. Predicate Device: OptiBond XTR (K101423)
- 4. Description of Device:

OptiBond eXTRa Universal is a two-component universal adhesive system including a PRIMER and an ADHESIVE. The OptiBond eXTRa Universal PRIMER provides effective etching to enamel and dentin without the need for a separate phosphoric acid etch, thus simplifying the bonding procedure (self-etch technique). OptiBond eXTRa Universal is compatible with total etch and selective etch techniques. The OptiBond eXTRa Universal ADHESIVE is 15% filled with 0.4 micron barium glass to help reinforce bond strength.

- 5. Indications for Use:

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Direct Bonding Applications

- Light-cured composite and compomer restorations. .
- . Composite/ceramic/metal repairs.
- o Cavity sealing for amalgam restorations.
- Sealing of hypersensitive and/or exposed root surfaces. .
- . Core build-ups (self-cured, light-cured, or dual-cured).

Indirect Bonding Applications

- Veneers. .
- . Self-cure, dual-cure, light-cure resin cements and core buildup materials.
- Porcelain, ceramic (including zirconia-based, lithium disilicate-based and . alumina-based), composite, and metal-based (including precious and non-precious metal inlays, onlays, crowns, bridges.
- . Endodontic posts.
- Cavity sealing as a pretreatment for indirect restorations. .

#### Summary of Non-Clinical Performance Data: 6.

The technological characteristics of subject device OptiBond eXTRa Universal is substantially equivalent to the predicate OptiBond XTR (K101423). Bench testing was conducted on a variety of self-cure or dual-cure resin cements and core-build up materials. The following performance tests were completed during the product lifecycle:

Non-clinical performance data includes testing for shear bond strength to various substrates. The data analyzed from the various tests substantiate that OptiBond eXTRa Universal performs similar to the predicate OptiBond XTR (K101423). The following standards were utilized for non-clinical performance testing of OptiBond eXTRa Universal :

- · ISO 10993-1: 2009 Biological Evaluation of Medical Devices
- · ISO 10993-3:2003 Biological Evaluation of Medical Devices- Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity
- ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in Vitro Cytotoxicity
- · ISO 10993-6:2007 Biological Evaluation of Medical Devices- Part 6: Tests for Local Effects after Implantation
- ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization
- · ISO 14971:2007 Risk Management
- ISO 29022:2013* Dentistry Adhesive-Notched Edge Sheer Bond Strength TestTesting of Adhesion to Tooth Structure

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### Summary of Technological Characteristics and Device Comparison: 7.

The proposed OptiBond eXTRa Universal has similarities in performance characteristics and design features as compared to the predicate. The nonclinical performance testing demonstrates that the OptiBond eXTRa Universal performs as well as the predicate device OptiBond XTR (K101423). OptiBond eXTRa Universal has been tested for its shear bond strength against a variety of materials (including enamel, dentin, and common substrates) in all etching modes. Additional conformational biocompatibility testing was performed on the proposed OptiBond eXTRa Universal. The first difference in technological characteristics between the two devices is the replacement of one of the monomers in the formulation to another monomer that has the same function. The other difference in technological characteristics is the difference in techniques that the devices are marketed for. While predicate OptiBond XTR is for self-etch techniques, OptiBond eXTRa Universal can also be used in total and selective etch techniques. These technological differences were evaluated by testing the in-vitro shear bond strength of OptiBond eXTRa Universal using all etching techniques and comparing the performance in all modes to the predicate OptiBond XTR. The performance of OptiBond eXTRa Universal in any mode is statistically equivalent to predicate device OptiBond XTR in self-etch mode and does not raise concerns of safety and effectiveness. The differences in the formulation and the differences in application techniques do not raise concerns of safety and effectiveness. and demonstrate the subject device is at least as safe and effective as the legally marketed predicate device.

| Element | Predicate<br>OptiBond XTR | Subject Device<br>OptiBond eXTRa Universal |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K101423 | K182162 |
| Manufacturer | Kerr Corporation | Kerr Corporation |
| Trade Name | OptiBond XTR | OptiBond eXTRa Universal |
| Target Users | Licensed Dental Professionals | Licensed Dental Professionals |
| Common Name | Bonding Agent | Same |
| Classification<br>Name | Resin Tooth Bonding Agent | Same |
| FDA Class | II, 21 CFR 872.3200 | Same |
| Product Code | KLE | Same |
| Device<br>Description | OptiBond XTR is a two-component self-etch universal adhesive system including a self-etch PRIMER and a universal ADHESIVE. The self-etch primer provides effective etching to uncut enamel and dentin, without the need for a separate phosphoric acid etch, thus simplifying the bonding procedure. The adhesive component is 15% filled with 0.4 | OptiBond eXTRa Universal is a two-component universal adhesive system including a self-etch PRIMER and a universal ADHESIVE. The OptiBond eXTRa Universal PRIMER provides effective etching to enamel and dentin without the need for a separate phosphoric acid etch, thus simplifying the bonding procedure (self-etch technique). OptiBond |
| Element | Predicate<br>OptiBond XTR | Subject Device<br>OptiBond eXTRa Universal |
| | micron barium glass to help<br>reinforce bond strength. The<br>material's chemistry allows for<br>compatibility with all self-cure or<br>dual-cure resin cements and core<br>build-up materials. Dentists can<br>therefore utilize OptiBond XTR<br>for their direct procedures without<br>the need for a secondary bonding<br>system. | eXTRa Universal is compatible with<br>total etch and selective etch<br>techniques. The OptiBond eXTRa<br>Universal ADHESIVE is 15% filled<br>with 0.4 micron barium glass to help<br>reinforce bond strength. The<br>material's chemistry allows for<br>compatibility with all self-cure or<br>dual-cure resin cements and core<br>build-up materials. Dentists can<br>therefore utilize OptiBond eXTRa<br>Universal for their direct and indirect<br>procedures without the need for a<br>secondary bonding system. |
| Intended Use | Resin tooth bonding agent used in<br>direct and indirect bonding<br>applications | Resin tooth bonding agent used in<br>direct and indirect bonding<br>applications |
| Indications for<br>Use | OptiBond XTR is a two-<br>component self-etch universal<br>adhesive system designed to be<br>used for all direct and indirect<br>applications including, but not<br>limited to, the following: | <b>Direct Bonding Applications</b><br>• Light-cured composite and<br>compomer restorations.<br>• Composite/ceramic/metal repairs.<br>• Cavity sealing for amalgam<br>restorations.<br>• Sealing of hypersensitive and/or<br>exposed root surfaces.<br>• Core build-ups (self-cured, light-<br>cured, or dual-cured). |
| | <b>Direct Applications</b><br>• Light-cured composite and<br>compomer restorations<br>• Composite/ceramic/metal repairs<br>• Cavity sealing for amalgam<br>restorations<br>• Sealing of hypersensitive and/or<br>exposed root surfaces<br>• Core build-ups (self-cured, light-<br>cured or dual-cured) | <b>Indirect Bonding Applications</b><br>• Veneers.<br>• Self-cure, dual-cure, light-cure<br>resin cements and core buildup<br>materials.<br>• Porcelain, ceramic (including<br>zirconia-based, lithium disilicate-<br>based and alumina-based),<br>composite, and metal-based<br>(including precious and non-precious<br>metal inlays, onlays, crowns,<br>bridges.<br>• Endodontic posts.<br>• Cavity sealing as a pretreatment for<br>indirect restorations. |
| | <b>Indirect applications</b><br>• Veneers<br>• Porcelain, composite, and metal-<br>based (including zirconia-based<br>and alumina-based) inlays, onlays,<br>crowns, bridges<br>• Endodontic posts<br>• Cavity sealing as a pretreatment<br>for indirect restorations | |
| Element | Predicate<br>OptiBond XTR | Subject Device<br>OptiBond eXTRa Universal |
| | | |
| Principles of<br>Operation | Primer is applied to tooth structure<br>to etch and prepare the surface,<br>then adhesive is applied<br>facilitating adhesion to the<br>restoration through micro-<br>mechanical interlocking and<br>chemical bonding | Same |
| Curing<br>Mechanism | Photo-initiation | Same |
| Bonding Agent<br>Type | 2 component system<br>(primer and adhesive) | Same |
| Technique | Self Etch | Self-etch, Total-etch, Selective-etch |
| Resin Type | methacrylate, GPDM | Same |
| Cure Time | Optilux 501 - 10 seconds<br>L.E.Demetron I - 10 seconds<br>L.E.Demetron II - 5 seconds<br>Demi/Demi Plus/Demi Ultra - 5<br>seconds<br>For all other lights see<br>manufacturer's recommendation. | Same |
| Substrate<br>Material<br>Compatibility | Dentin, enamel, composite,<br>ceramic, metal, amalgam | Same |
| Biocompatibility | Biocompatible per ISO 10993 | Same |
| Storage<br>conditions | Refrigerate upon receipt, between<br>2 o - 8oC | Same |
| Shelf Life | 2 years | Same |
| Accessories | Mixing well, applicator brushes | Same |
| Packaging Type<br>(Delivery<br>System) | Bottle, Unidose (nonsterile) | Same |

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- 8. Clinical Performance Data: The company did not conduct clinical performance testing for OptiBond eXTRa Universal.
- 9. Conclusion as to Substantial Equivalence: Based on technology, intended use, biocompatibility testing and non-clinical performance testing, the subject device OptiBond eXTRa Universal (K182162) is substantially equivalent to the predicate device OptiBond XTR (K101423).