(121 days)
Use for virtually all etching and bonding needs in restorative dentistry for dental patients of all ages. Peak™ Universal Bond bonds to the following materials: Dentin and enamel, Porcelain, Metal, Composite.
Peak™ Universal Bond is a single syringe delivered resin bond. It can be used with Peak™ SE or with a total etch. It is 7.5% filled with an ethyl alcohol solvent carrier and will cure with most high intensity lights including LEDs. Chlorhexidine is used to ensure long term bond strengths.
The provided text describes a Traditional 510(k) premarket summary for Peak™ Universal Bond, a dental resin bond. It outlines the device, its intended use, comparison to predicate devices, and a brief description of the testing performed.
However, the document does not contain a table of acceptance criteria or detailed study results with specific performance metrics and sample sizes that would allow for a comprehensive description as requested. The text only states that "The test data shows that Peak™ Universal Bond has higher shear bond strengths than Peak™ Bond, which was superior to its predicates when tested in (K063557) and NexTemp." without providing the actual values or the specific criteria against which these strengths were judged.
Therefore, many of the requested items cannot be answered definitively from the provided text. Below is an attempt to extract what is available and identify what is missing.
Acceptance Criteria and Device Performance Study for Peak™ Universal Bond
The document provided does not contain a specific table of acceptance criteria or detailed numerical device performance against those criteria. It broadly states that the device demonstrated "higher shear bond strengths."
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shear Bond Strength | Not explicitly stated in the provided text, but implied to be superior to predicates. | "Peak™ Universal Bond has higher shear bond strengths than Peak™ Bond, which was superior to its predicates when tested in (K063557) and NexTemp." |
| Shelf Life | Not explicitly stated in the provided text. | 18 months (based on accelerated stability studies) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in the provided text.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It implies the testing was performed by Ultradent Products, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The "ground truth" in this context would likely refer to the actual bond strength measurements from laboratory testing, not expert consensus on an image or clinical assessment.
4. Adjudication method for the test set
This information is not applicable and not provided. Adjudication methods are typically relevant for human-interpreted data (e.g., medical images).
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This type of study is meant for evaluating diagnostic devices where human readers interpret cases, often with and without AI assistance. This document describes a dental bonding agent, and the testing focuses on material properties like bond strength and stability.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable to a dental bonding agent, as it is a material, not a software algorithm. The "standalone" performance refers to the inherent physical and chemical properties of the bond itself.
7. The type of ground truth used
The ground truth for the test results (shear bond strength) would be the laboratory measurements obtained from destructive mechanical testing of the bonded specimens.
8. The sample size for the training set
This question is not applicable as the device is a material, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated above.
Summary of Study Described:
The study involved repeating "the exact same testing as was performed on Peak™ Bond (K063557)." This included testing the bond strength of Peak™ Universal Bond compared to Peak™ LC and NexTemp, using both a Total Etch system and a Self Etch System. Additionally, all three products were subjected to thermal cycling, and bond strength parameters were re-tested. The document states that the test data showed Peak™ Universal Bond to have higher shear bond strengths than Peak™ Bond, which was superior to its predicates when previously tested. Stability testing was also conducted, indicating an 18-month shelf life. The specifics of how many samples were tested in each condition, the exact values of the bond strengths, or the methods used to measure them are not detailed in this summary.
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JUL 1 3 2010
KCO0752
TRADITIONAL 510(K) PREMARKET SUMMARY
Peak™ Universal Bond
This summary of the Traditional 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 for Peak™ Universal Bond.
Applicant's Name and Address
Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095
Contact Person: Title: Telephone: FAX: Date Summary Prepared: Diane Rogers Regulatory Affairs Manager 800-552-5512 x4491, 801-553-4491 801-553-4609 March 3, 2010
Name of the Device
Trade Name: Common Name: Device Classification: Classification Product Code: Peak™ Universal Bond Agent, Tooth bonding, Resin ll KLE
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Legally Marketed Predicate Device to Which Equivalence is Claimed
The first predicate device is: Peak™ Bond (KO63557). This device is manufactured and distributed by Ultradent Products, Inc., 505 West, 10200 South, South Jordan, Utah 84095. Peak Bond and Peak Universal Bond are exactly the same product with only the addition of 0.2 Chlorhexidine Diacetate. The second predicate device is Premier NexTemp (K051866) manufactured and distributed by Premier Dental Products, 1710 Romano Drive, Plymouth meeting, PA 19462.
Product Description: Peak™ Universal Bond is a single syringe delivered resin bond. It can be used with Peak™ SE or with a total etch. It is 7.5% filled with an ethyl alcohol solvent carrier and will cure with most high intensity lights including LEDs. Chlorhexidine is used to ensure long term bond strengths.
Indications for Use: Use for virtually all etching and bonding needs in restorative dentistry for dental patients of all ages.
Peak™ Universal Bond bonds to the following materials:
- Dentin and enamel .
- � Porcelain
- Metal ♥
- Composite .
Traditional 510(k) for Peak™ Universal Bond
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Comparison Table Table
| Peak™ Universal Bond(K100752) | Peak™ Bond(K063557) | Premier NexTemp(K051866) | |
|---|---|---|---|
| IndicationsFor Use | Use for virtually all etching andbonding needs in restorativedentistry.Peak™ Universal Bond bondsto the following materials:Dentin and enamel Porcelain Metal Composite | Use for virtually alletching and bondingneeds in restorativedentistry.Peak™ Bond bondsto the followingmaterials:Dentin and enamel Porcelain Metal Composite | Non-eugenolresin-matrixformulationto combinethe multiplebenefits offluoriderelease toprotect toothstructure,potassiumnitrate forpatientcomfort andchlorhexidineas an anti-bacterialagent. |
| DeliverySystem | Syringe | Syringe | Syringe |
Technological Characteristics:
Peak™ Universal Bond is a single syringe delivered resin bond. It can be used with Peak™ SE or with a total etch. It is 7.5% filled with an ethyl alcohol solvent carrier and will cure with most high intensity lights including LEDs. Chlorhexidine is used to ensure long term bond strengths. Both devices have the same technological characteristics before the addition of chlorhexidine. New characteristics are added to enhance the length of the bond strength in Peak Universal Bond.
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The purpose of this Traditional 510(k) is to inform the FDA of our intent to market a new product, Peak™ Universal Bond. This product can be used for dental patients of all ages. Peak™ Bond (K063557) and Premier NexTemp (K051866) are our predicates. The formula has been modified as follows:
- Add 0.2 Chlorhexidine Diacetate �
Our goal is to release Peak™ Universal Bond as a new product potentially replacing Peak™ Bond.
The Indications for Use remains the same as Peak™ Bond. New labeling and packaging have been added to reflect Peak™ Universal Bond as a new product which is an improvement over Peak™ Bond with the addition of chlorhexidine which was added to ensure long term bond strengths.
Peak Universal Bond is a dental composite material used for virtually all etching and bonding needs in restorative dentistry.
Brief Description of Testing Performed
We repeated the exact same testing as was performed on Peak™Bond (K063557). The bond strength that was tested on Peak™LC compared to Peak™ Universal bond and NexTemp using a Total Etch system and a Self Etch System. Then, all three products were thermal cycled and all parameters were again tested. The test data is included in Section IV. The test data shows that Peak™ Universal Bond has higher shear bond strengths than Peak™ Bond, which was superior to its predicates when tested in (K063557) and NexTemp.
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Stability Testing for Shelf Life
Stability testing was also conducted on Peak Universal Bond and the results showed that the product has an 18 month shelf life based on accelerated stability studies conducted in R & D. The timing of seven weeks of storage at a temperature elevated 36°C above ambient is equivalent to 84.9 weeks or 19.5 months of real time shelf life.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three lines representing the branches of government.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 1 32010
Ms. Diane Rogers Regulatory Affairs Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095
Re: K100752
Trade/Device Name: Peak™ Universal Bond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: June 24, 2010 Received: June 25, 2010
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. 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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Page 2- Ms. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Anthony D. Watson, B.S., M.S., M.B.A. 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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Statement of Indications for Use
510(k) Number (if known):
Device Name: _ Peak™ Universal Bond
Indications for Use:
Use for virtually all etching and bonding needs in restorative dentistry for patients of all ages.
Peak™ Universal Bond bonds to the following materials:
- Dentin and enamel �
- Porcelain
- Metal .
- Composite
AND/OR Over-The-Counter Use Prescription Use _ X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
C l Hee
Page 1 of 1
(Posted November 13, 2003)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K100752
Traditional 510(k) for Peak™ Universal Bond
§ 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.