(17 days)
Use for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to:
- Dentin and enamel
- Porcelain
- Metal
- Composite
Peak TM SE Bonding System is a syringe delivered self-etching primer component of the PeakTM Resin Bonding System.
The provided document is a 510(k) premarket notification for a dental bonding system called Peak™ SE. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on testing. However, the document does not include detailed acceptance criteria or a study write-up with specific performance metrics, sample sizes, or ground truth establishment relevant to the format requested in the prompt.
The document states: "All of our testing concluded that Peak™ SE has met or exceeded our testing expectations." but does not provide the specifics of these expectations or the results. Therefore, I cannot generate the requested table and detailed study information.
Here's an explanation of what can be extracted and what is missing based on your and the prompt's requirements:
Information Present in the Document:
- Device Name: Peak™ SE
- Intended Use: For use in most light-accessible bonding procedures in both the anterior and posterior, with Peak™ Bond Adhesive for dentin, enamel, porcelain, and composite bonding.
- Legally Marketed Predicate Devices: PermaQuick™ SE Bonding System (Ultradent Products, Inc.) and Clearfil SE Bond (Kuraray America Inc.).
- Testing Performed (General Categories): Intended Use, Description, Biocompatibility and Safety, Properties, Ease of Use, Ingredients, Radiopacity, Shrinkage, and Bond Strength.
- Conclusion of Testing: Peak™ SE "met or exceeded our testing expectations" and is "substantially equivalent" to predicate devices.
- Regulatory Classification: Class II, Resin Tooth Bonding Agent.
Information NOT Present in the Document (and therefore cannot be provided in the requested format):
- Detailed Acceptance Criteria and Reported Device Performance (Table): The document generally states that "testing concluded that Peak™ SE has met or exceeded our testing expectations" but does not specify what those expectations (acceptance criteria) were or the actual numerical results (reported device performance) for any of the categories (e.g., specific bond strength values, shrinkage percentages, radiopacity standards).
- Sample Sizes Used for the Test Set: Not mentioned.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned.
- Number of Experts Used to Establish the Ground Truth and Qualifications: Not applicable as it's a materials science/engineering test, not an AI diagnostic device.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable (this is not an AI diagnostic device).
- Standalone Performance (algorithm only without human-in-the-loop performance): Not applicable.
- Type of Ground Truth Used: The testing involved physical/chemical properties of a bonding agent, likely measured against established material standards (e.g., ISO standards for dental materials). The document doesn't specify these standards.
- Sample Size for the Training Set: Not applicable as this is not an AI/machine learning device that uses a "training set." The testing described is for a physical product, not a model.
- How the Ground Truth for the Training Set Was Established: Not applicable.
Summary of Device Performance (Based on available qualitative statements):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use | Met/Exceeded Expectations |
| Description | Met/Exceeded Expectations |
| Biocompatibility & Safety | Met/Exceeded Expectations |
| Properties | Met/Exceeded Expectations |
| Ease of Use | Met/Exceeded Expectations |
| Ingredients | Met/Exceeded Expectations |
| Radiopacity | Met/Exceeded Expectations |
| Shrinkage | Met/Exceeded Expectations |
| Bond Strength | Met/Exceeded Expectations |
Note: The document only provides qualitative statements ("met or exceeded our testing expectations") and does not specify the quantitative acceptance criteria or the numerical performance results for these categories.
2. Sample sized used for the test set and the data provenance: Not specified in the document. The testing was conducted by the manufacturer, Ultradent Products, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; this is a materials test, not an expert-based diagnostic assessment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable; this is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a dental material, the "ground truth" would typically be established by objective physical and chemical testing methods (e.g., mechanical testing standards for bond strength, material composition analysis, radiopacity measurement against a standard) rather than expert consensus on diagnostic images or pathology. The specific standards or methods are not detailed in this summary.
8. The sample size for the training set: Not applicable; this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo for Ultradent Products, Inc. The logo features a stylized "U" and "a" to the left of the word "ULTRADENT" in a bold, sans-serif font. Below "ULTRADENT" is the text "PRODUCTS, INC." in a smaller, thinner font. The logo is black and white.
SPECIAL 510(K) PREMARKET SUMMARY
Peak™ SE
DEC 1 4 - 3
This summary of the Special 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 for Peak™ SE.
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 20, 2006
Name of the Device:
Trade name: Common Name: Classification Name: Risk Class: Classification Product Code: Peak™ SE SE Resin Bonding System Resin Tooth Bonding Agent II, (21 CFR 872.3200) 76KLE
Legally Marketed Predicate Devices to which Equivalence is Claimed:
PermaQuickTM SE Bonding System K032626 Manufactured and distributed by Ultradent Products, Inc. 505 West 10200 South, South Jordan, Utah 84095.
Clearfil SE Bond K990040
Manufactured and Distributed by Kuraray America Inc. 101 East 52nd Street, 26th Floor New York, NY 10122
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Image /page/1/Picture/0 description: The image contains the logo for Ultradent Products, Inc. The logo features a stylized "U" and "D" on the left, followed by the word "ULTRADENT" in bold, uppercase letters. Below "ULTRADENT" is the phrase "PRODUCTS, INC." in a smaller, sans-serif font.
Device Description and Performance Characteristics:
Peak TM SE Bonding System is a syringe delivered self-etching primer component of the PeakTM Resin Bonding System.
Intended Use:
For use in most light-accessible bonding procedures in both the anterior and posterior. Peak™ SE is used with Peak™ Bond Adhesive for dentin, enamel porcelain and composite bonding.
Technological Characteristics:
Peak™ SE is a syringe delivered self-etching primer component of the Peak™ Resin Bonding System. Our unique MixSyr delivery (syringe-in-syringe) ensures a fresh mix of chemistry for every procedure. Peak™ SE is to be used specifically with our syringe delivered, light cured bonding agent. PeakTM Bond. Peak™ SE is 7.5% filled and radiopaque. The system will cure with most high intensity lights including LEDs.
Brief Description of Testing Performed and Conclusion:
Peak TM SE was designed, tested and compared to its predicates, PermaQuick™ SE, Ultradent Products, Inc. and Clearfil SE, Kuraray Co. Ltd. in the following categories: Intended Use, Description, Biocompatibility and Safety, Properties, Ease of Use, Ingredients, Radiopacity, Shrinkage and Bond Strength. All of our testing concluded that Peak™ SE has met or exceeded our testing expectations.
Substantial Equivalence
In conclusion, Peak™ SE, that is to be manufactured and marketed by Ultradent Products, Inc., 505 West 10200 South, South Jordan, Utah 84095, is substantially equivalent to our PermaQuick™ SE which has the same intended use, and are equally safe for the indications as described. Please feel free to contact me for further explanation and dialogue with respect to this product, as it is my understanding that the product is substantially equivalent to products
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Image /page/2/Picture/0 description: The image shows the logo for Ultradent Products, Inc. The logo features a stylized "U" 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 overall design is simple and professional.
Image /page/2/Picture/1 description: The image shows a black and white photograph of a rocky landscape. The top portion of the image shows a large rock formation with a dark, shadowed area beneath it. The bottom portion of the image shows a more textured, possibly grassy or rocky area. There are two white circles in the image, one in the shadowed area of the rock formation and one in the textured area.
legally marketed for this indication. I can be reached for discussion at the number listed above and would appreciate the opportunity to further clarify as necessary.
Diane Rogers
Regulatory Affairs Product Specialist
November 20, 2006
Date
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Image /page/3/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
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 4 2006
Re: K063558 Trade/Device Name: Peak™ SE Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: November 21, 2006 Received: December 08, 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 (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.
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,
Chih-S. Liu, 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™ SE
Indications for Use:
Use for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to:
- Dentin and enamel o
- Porcelain 0
- o Metal
- 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)
Susan Runpe
rent problem Grand Con . Connol, Denel Dovices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.