(2 days)
K100752 Peak Universal Bond
No
The summary describes a dental bonding resin and its physical properties and testing, with no mention of AI or ML.
Yes.
The device's mode of action "produces a mechanical occlusion of dentin tubules by the resins, thus reducing tooth hypersensitivity," which constitutes a therapeutic effect.
No
This device is described as a bonding resin used in restorative dentistry for etching, bonding, and desensitizing tooth structure. Its function is to produce a mechanical occlusion of dentin tubules to reduce tooth hypersensitivity and bond various dental materials. It does not mention analyzing or interpreting any data to diagnose a condition.
No
The device description explicitly states it is a "bottle, syringe, or unit dose delivered bonding resin," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "etching and bonding needs in restorative dentistry" and "desensitizing/sealing of tooth structure." This describes a device used directly on the patient's tooth structure for treatment and restoration.
- Device Description: The description details a "bonding resin" applied to the tooth.
- Anatomical Site: The anatomical site is "tooth structure."
- Mode of Action: The mode of action is described as "mechanical occlusion of dentin tubules by the resins."
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device is applied to the body for a therapeutic or restorative purpose, not for analyzing a specimen.
N/A
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
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth structure (Dentin and Enamel)
Indicated Patient Age Range
patients of all ages
Intended User / Care Setting
dental professionals / restorative dentistry
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)
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.
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.
K100752 Peak Universal Bond
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.
K230465 Hi-Bond Universal
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: 801-557-1125 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).