(17 days)
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No
The document describes a dental bonding system and does not mention any AI or ML components.
No.
The device is a bonding agent used in restorative dentistry, which is a material used to adhere dental restorations to teeth, not a therapeutic device designed to treat or cure a disease or medical condition.
No
The device description and intended use indicate it is a bonding system used in restorative dentistry, not a device that diagnoses medical conditions.
No
The device description clearly states it is a "syringe delivered self-etching primer component," indicating it is a physical substance and delivery system, 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 bonding in restorative dentistry, specifically for bonding dental materials like composites and luting agents to tooth structure (dentin and enamel) and other dental materials (porcelain, metal, composite). This is a direct application within the body (or on tissues that were recently part of the body), not for examining specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The device is a bonding system, a material used to adhere dental restorations.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It's a therapeutic/restorative device.
- Anatomical Site: The anatomical site is dentin and enamel, which are parts of the tooth structure within the body.
IVD devices are used to examine specimens like blood, urine, or tissue samples in vitro to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for 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.
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
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
Peak TM SE Bonding System is a syringe delivered self-etching primer component of the PeakTM 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.
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)
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.
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 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
3
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
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