Use for most bonding needs in restorative dentistry. Peak™ Bond is formulated to work well with flowable composite for light cure luting. Ultradent recommends the PermaFlow® DC system using chemical cure PermaFlow® DC primer for chemical cure/dual core bonding (e.g., non-translucent veners, inlays, and post bonding). Peak™ Bond bonds to the following materials: Dentin and enamel, Porcelain, Metal, Composite.

Device Description

Peak™ Bond is a single syringe delivered, single component resin bonding system. It is a light curing bonding agent with an ethyl alcohol solvent carrier. It will cure with most all lights (not laser). Peak™ Bond is 7.5% filled and is radiopaque. Peak™ Bond is a single resin-bonding agent that provides high bond strength and helps prevent micro leakage. It's unsurpassed filler penetration into dentin tubles helps minimize sensitivity. It is radiopaque, has an ethyl alcohol carrier, cures with all lights and is used with light curing indirect bonding. Peak Bond's unique and patented chemistry bonds to dentin/enamel, cast metal, porcelain and composite. It is also effective for indirect procedures where light curing is possible.

AI/ML Overview

The provided text is a Special 510(k) Premarket Summary for a dental bonding agent called Peak™ Bond, and the FDA's response letter. It focuses on demonstrating substantial equivalence to a predicate device (PQ1®) through various comparisons and testing.

Here's an analysis of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" with numerical thresholds in the typical sense for a medical device. Instead, the acceptance criterion implicitly appears to be "met or exceeded testing expectations" when compared to the legally marketed predicate device (PQ1®). The performance is reported qualitatively as "Peak™ Bond has met or exceeded our testing expectations. It is simply a thinner version of our PO1."

Acceptance Criteria	Reported Device Performance (Peak™ Bond)
Intended Use: Same as predicate	Same as predicate (Use for most bonding needs in restorative dentistry; formulated to work well with flowable composite for light cure luting).
Bonding: Same as predicate	Bonds to Dentin and enamel, Porcelain, Metal, Composite (Same as predicate).
Description: Single resin bonding agent, 7.5% filled, radiopaque, light curing, ethyl alcohol solvent carrier.	Single resin bonding agent, 7.5% filled, radiopaque, light curing, ethyl alcohol solvent carrier.
Biocompatibility and Safety: Passed cytotoxicity testing.	Passed cytotoxicity testing (Same as predicate).
Properties: Radiopaque, light curing.	Radiopaque, light curing (Same as predicate).
Technological Characteristics: High bond strength, helps prevent micro leakage, minimizes sensitivity due to filler penetration into dentin tubules.	Provides high bond strength, helps prevent micro leakage, unsurpassed filler penetration into dentin tubules helps minimize sensitivity. Bonds to dentin/enamel, cast metal, porcelain, and composite.
Other Tests (implicitly compared to predicate): % Filled, Ingredients, Radiopacity, Shrinkage, Bond Strength.	Met or exceeded testing expectations for these categories, implying performance is equivalent or better than the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide specific details on the sample size for any of the tests conducted (e.g., cytotoxicity, shrinkage, bond strength). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the studies described are laboratory tests of a dental bond agent's physical and chemical properties, not diagnostic imaging or clinical studies requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable, as there is no mention of human-in-the-loop assessment or any form of adjudication for the test set. The tests described are laboratory-based material property assessments.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Such a study was not done. This document describes a dental bonding agent, not an AI or diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable, as this is a dental product, not an algorithm or AI device. The testing performed focused on product performance (e.g., bond strength, radiopacity, biocompatibility).

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the laboratory tests mentioned (e.g., cytotoxicity, shrinkage, bond strength), the "ground truth" would be established by the physical and chemical measurements obtained from validated scientific methods and instrumentation, compared against established standards or the performance of the predicate device. It's not based on expert consensus, pathology, or outcomes data in the sense of clinical diagnoses.

8. The sample size for the training set

This is not applicable. The device is a dental bonding agent, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable. As stated above, there is no AI or machine learning model involved.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Ultradent Products, Inc. The logo consists of a stylized "U" on the left, followed by the word "ULTRADENT" in bold, sans-serif font. Below "ULTRADENT" is the phrase "PRODUCTS, INC." in a smaller, sans-serif font.

063557

SPECIAL 510(K) PREMARKET SUMMARY

Peak™ Bond

DEC I 2 2006

This summary of the Special 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 for PeakTM Bond.

Applicant's Name and Address:

Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095

Telephone Number: Fax Number: Contact Person: Date Summary Prepared

(801) 553-4491 (801) 553-4609 Diane Rogers, R/A Product Specialist November 15, 2006

Name of the Device:

Trade name: Common Name: Classification Name: Risk Class: Classification Product Code: Peak™ Bond Bonding Resin Agent, Tooth Bonding, Resin II, (21 CFR 872-3200) 76KLE

Legally Marketed Predicate Devices to which Equivalence is Claimed:

PQ1®/ Ultradent Products, Inc. /K023042 Manufactured and Predicate: distributed by Ultradent Products, Inc. 505 West 10200 South, South Jordan, Utah 84095.

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Image /page/1/Picture/0 description: The image shows the logo for Ultradent Products, Inc. The logo consists of a stylized "U" symbol on the left, followed by the word "ULTRADENT" in bold, uppercase letters. Below "ULTRADENT" is the phrase "PRODUCTS, INC." in smaller, uppercase letters. The logo is simple and modern, with a focus on the company name.

Product Comparison

Product	PeakTM Bond	PQI®
Intended Use	Use for most bondingneeds in restorativedentistry. Peak TM Bondis formulated to workwell with flowablecomposite for light cureluting.	Same
Bonding	PeakTM Bond bonds tothe following materials:Dentin and enamelPorcelainMetalComposite	Same
Description	Single resin bondingagent	Same
Biocompatibility andSafety	Passed cytotoxicitytesting	Same
Properties	Radiopaque, light curing	Same

Device Description and Performance Characteristics:

Intended Use:

Peak™ Bond is used for most bonding needs in restorative dentistry. It is formulated to work well with flowable composites for light cure luting. Peak™ Bond bonds to the following materials:

Dentin and enamel Porcelain Metal Composite

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Image /page/2/Picture/0 description: The image shows the logo for Ultradent Products, Inc. The logo consists of a stylized "U" symbol on the left, followed by the word "ULTRADENT" in bold, uppercase letters. Below "ULTRADENT" is the phrase "PRODUCTS, INC." in a smaller, thinner font. The logo is simple and professional, conveying a sense of reliability and innovation.

Technological Characteristics:

Peak™ Bond is a single resin-bonding agent that provides high bond strength and helps prevent micro leakage. It's unsurpassed filler penetration into dentin tubles helps minimize sensitivity. It is radiopaque, has an ethyl alcohol carrier, cures with all lights and is used with light curing indirect bonding.

Peak Bond's unique and patented chemistry bonds to dentin/enamel, cast metal, porcelain and composite. It is also effective for indirect procedures where light curing is possible.

Brief Description of Testing Performed and Conclusion:

Bond was tested and compared to its predicate, PQ1, Ultradent Peak TM Products, Inc. in the following categories: Intended Use, Description, Biocompatibility and Safety, Properties, Ease of Use, % Filled, Ingredients, Radiopacity, Shrinkage and Bond Strength. All of our testing concluded that Peak™ Bond has met or exceeded our testing expectations. It is simply a thinner version of our PO1.

Substantial Equivalence

In conclusion, Peak™ Bond, that is to be manufactured and marketed by Ultradent products, Inc., 505 West 10200 South, South Jordan, Utah 84095, is substantially equivalent to our PQ-1 which, for the most part is the same material, the same intended use, and are equally safe for the indications as described. Please feel free to contact us for further explanation and dialogue with respect to this product, as it is our understanding that the product is substantially equivalent to products legally marketed for this indication. We can be reached for discussion at the number listed above and we would appreciate the opportunity to further clarify as necessary.

Diane Rogers

Diane Rogers Regulatory Affairs Product Specialist

November 30, 2016
Date

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Diane Rogers Regulatory Affairs Product Specialist Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095

DEC 1 2 2006

Re: K063557 Trade/Device Name: Peak™ Bond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: November 21, 2006 Received: November 30, 2006

Dear Ms. Rogers:

. . .

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Ms. Diane Rogers

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Chin- S. Lin, Ph.D.

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K063557

Device Name: Peak™ Bond

Indications for Use:

Peak™ Bond bonds to the following materials:

Dentin and enamel ം
Porcelain o
Metal o
Composite o

Prescription Use × (21 CFR Part 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Syper Runga

Page 1 of

Regulation Number and Section

§ 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.