(15 days)
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No
The document describes a dental bonding agent and its properties, with no mention of AI or ML technology.
No
The device is a bonding agent used in restorative dentistry to bond dental materials, not to treat or cure a disease or condition.
No
Explanation: The device description clearly states that Peak™ Bond is a "single component resin bonding system" used for bonding materials in restorative dentistry. Its function is to bond, not to diagnose a condition or disease.
No
The device description clearly indicates it is a physical resin bonding system delivered via a syringe, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "most bonding needs in restorative dentistry." This describes a therapeutic or restorative purpose within the body (in vivo), not a diagnostic test performed on samples taken from the body (in vitro).
- Device Description: The description details a "single component resin bonding system" used for bonding materials like dentin, enamel, porcelain, metal, and composite. This aligns with a material used in dental procedures, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. It's purely for bonding materials during restorative procedures.
- Anatomical Site: The anatomical site is "Dentin and enamel," which are parts of the tooth structure where the bonding material is applied directly. This is consistent with an in vivo application.
IVD devices are typically used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Use for most bonding needs in restorative dentistry. Peak TM 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
Product codes (comma separated list FDA assigned to the subject device)
76KLE, KLE
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Dentin and enamel
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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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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 bonding | |
| needs in restorative | ||
| dentistry. Peak TM Bond | ||
| is formulated to work | ||
| well with flowable | ||
| composite for light cure | ||
| luting. | Same | |
| Bonding | PeakTM Bond bonds to | |
| the following materials: | ||
| Dentin and enamel | ||
| Porcelain | ||
| Metal | ||
| Composite | Same | |
| Description | Single resin bonding | |
| agent | Same | |
| Biocompatibility and | ||
| Safety | Passed cytotoxicity | |
| testing | Same | |
| Properties | Radiopaque, light curing | Same |
Device Description and Performance Characteristics:
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.
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:
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 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
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