Peak Universal Bond

K240743 · Ultradent Products, Inc. · KLE · Mar 20, 2024 · Dental

Device Facts

• Record ID: K240743
• Device Name: Peak Universal Bond
• Applicant: Ultradent Products, Inc.
• Product Code: KLE · Dental
• Decision Date: Mar 20, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

Use for virtually all etching and bonding needs in restorative dentistry for patients of all ages. Peak Universal Bond is used for desensitizing/sealing of tooth structure. Peak Universal Bond adhesive bonds to the following materials: - Dentin and Enamel - Porcelain, Zirconia - Metal - Composite

Device Story

Peak Universal Bond is a resin bonding agent delivered via bottle, syringe, or unit dose. Used in restorative dentistry by dental professionals; supports self-etch or total-etch techniques. Contains 7.5% filler, ethyl alcohol solvent, and 0.2% chlorhexidine. Cures via high-intensity light (e.g., LEDs). Mechanism involves mechanical occlusion of dentin tubules by resins to reduce tooth hypersensitivity. Provides adhesion to dentin, enamel, porcelain, zirconia, metal, and composite. Clinical benefit includes long-term bond strength and reduction of tooth sensitivity.

Clinical Evidence

Bench testing only. Verification testing performed per ISO 29022:2013. SEM imaging used to confirm dentinal tubule blockage. Simulated use and validation testing conducted by dental professionals confirmed device meets user needs and indications for use.

Technological Characteristics

Resin bonding agent; 7.5% filled with ethyl alcohol solvent; contains 0.2% chlorhexidine. Cures via high-intensity light. Tested to ISO 29022:2013. Delivered in bottle, syringe, or unit dose.

Indications for Use

Indicated for patients of all ages requiring etching and bonding in restorative dentistry, including desensitizing and sealing of tooth structure. Bonds to dentin, enamel, porcelain, zirconia, metal, and composite.

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

• Peak Universal Bond (K100752)
• Hi-Bond Universal (K230465)

Submission Summary (Full Text)

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March 20, 2024

Ultradent Products, Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K240743

Trade/Device Name: Peak Universal Bond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin tooth bonding agent Regulatory Class: Class II Product Code: KLE Dated: March 18, 2024 Received: March 18, 2024

Dear Dave Yungvirt:

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.

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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 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, COIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K240743

Device Name Peak Universal Bond

Indications for Use (Describe)

Use for virtually all etching and bonding needs in restorative dentistry for patients of all ages. Peak Universal Bond is used for desensitizing/sealing of tooth structure.

Peak Universal Bond adhesive bonds to the following materials:

- · Dentin and Enamel
- Porcelain, Zirconia
- · Metal
- · Composite

| 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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# 510(k) Summary

## Contact Details

Applicant Name: Ultradent Products, Inc. Applicant Address: 505 West Ultradent Drive, South Jordan, UT, 84095 Applicant Contact Telephone: [phone] Applicant Contact: Dr. Carolyn Taylor Applicant Contact Email: Carolyn.taylor(@ultradent.com

### Device Name

Device Trade Name: Peak Universal Bond Common Name: Resin tooth bonding agent Classification Name: Agent, Tooth Bonding, Resin Regulation Number: 872.3200 Product Code(s): KLE

#### Legally Marketed Predicate Devices

K100752 Peak Universal Bond - KLE K230465 Hi-Bond Universal - KLE

#### Device Description Summary

Peak™M Universal Bond is a bottle, syringe, or unit dose delivered bonding resin. It can be used with selfetch or with total etch techniques. It is 7.5% filled with an ethyl alcohol solvent carrier and will cure with most high intensity lights including LEDs. Peak Universal Bond adhesive contains 0.2% chlorhexidine which may ensure long term bond strengths. Its mode of action produces a mechanical occlusion of dentin tubules by the resins, thus reducing tooth hypersensitivity.

#### Intended Use/Indications for Use

Use for virtually all etching and bonding needs in restorative dentistry for patients of all ages. Peak Universal Bond is used for desensitizing/sealing of tooth structure.

Peak Universal Bond adhesive bonds to the following materials:

- · Dentin and Enamel
- · Porcelain, Zirconia
- Metal
- · Composite

### Indications for Use Comparison

The indications for use between the subject device and primary predicate are identical with the addition of zirconia and desensitizing/sealing of tooth structure. The secondary predicate contains both of these indications for use.

#### Technological Comparison

The subject device and primary predicate are identical structure and technological characteristics. The only change in this Special 510(k) application between the primary predicate and the subject device is in the intended use. The subject device includes the indications for use of bonding to zirconia as well as desensitizing/sealing the tooth structure. The secondary predications

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for use and is tested to many of the same standards as the subject device. There are some minor differences in formulation between the subject device and secondary predicate, but the standard of testing remains the same. The subject device shear bond testing has been performed to ISO 29022 and adheres to this standard. The shear bond testing of the secondary predicate was performed to ISO 11405. This standard has been withdrawn, but follows the same principles as ISO 29022 which is the updated standard for testing dental adhesives. The secondary predicate was tested for dentinal tubule blockage. The subject device was also tested for this using SEM imaging of the device applied to the tooth. The physical properties of the subject device, predicate devices, and secondary predicate device are all the same. None of the differences in the devices impact safety or efficacy of the device.

Overall, these slight differences do not introduce new questions related to product risk, nor do they impact the safety or efficacy of the subject device as compared to the predicate product. As such, the subject device can be considered substantially equivalent to the predicate device.

#### Non-Clinical and/or Clinical Tests Summary & Conclusions

Verification and validation testing was performed to show that the subject device is substantially equivalent to the currently marketed predicate device, Peak Universal Bond. Full verification testing to ISO 29022:2013 and SEM imaging were completed to support the additional indications for use of this device to the primary predicate in accordance with the same testing performed to support these indications in the secondary predicate, Hi-Bond Universal K230465.

All additional verification testing was performed in accordance with Risk Management Procedures outline in SOP QA 0028 which was prepared in accordance with ISO 14971. Simulated use and validation testing was conducted by dental professionals to confirm that all aspects from usability assessments and risk management were implemented in the labeling and the design of the device itself. The conclusion of this validation testing confirmed that the subject device met the predefined user needs and the indications for use, which are identical to the primary predicate device and/or the secondary predicate. Thus the verification and validation support the conclusion that the subject device, Peak Universal Bond, is substantially equivalent to the predicate device, Peak Universal Bond (K100752).