(73 days)
Ascent Universal Adhesive is intended for all direct and indirect restorations where light cure is possible. It is indicated as an adhesive for: light cured restorative composites, Methacrylate resin cements, dentin, enamel, metal alloys and porcelain.
Ascent Universal Adhesive is indicated for direct bonding to:
- Dentin
- Enamel
- Composite
- Porcelain
- Metal
The Ascent Universal Adhesive is an ethanol-based composition containing a special formulation of resins to achieve an excellent bond to materials such as restorative composites, dentin, enamel, metals and porcelain. The composition is polymerized by means of a dental polymerization light source.
The provided document is a 510(k) summary for a dental adhesive, Ascent Universal Adhesive. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting an extensive study with detailed acceptance criteria and performance metrics typically found for AI/software-as-a-medical-device.
Based on the content of the provided text, the following information can be extracted:
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Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states "Performance Standards: None" and "Performance Data: See Part 7: Performance Data". Since "Part 7: Performance Data" is not included in the provided text, a table of specific acceptance criteria and reported device performance cannot be created from the given information. The submission relies on demonstrating substantial equivalence to a predicate device rather than meeting specific performance metrics against defined acceptance criteria.
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Sample size used for the test set and the data provenance:
No information is provided regarding a "test set" or its sample size or data provenance. The submission focuses on comparing the proposed device's characteristics to a predicate device rather than conducting a performance study on a test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. There is no mention of a test set, ground truth establishment, or experts involved in such a process.
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Adjudication method for the test set:
Not applicable. No test set is described.
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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/software-as-a-medical-device submission. No MRMC study or AI assistance is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/software-as-a-medical-device submission.
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The type of ground truth used:
Not applicable. There is no concept of "ground truth" as relevant to performance evaluation of an AI-driven device in this document. The assessment is based on material composition, intended use, and application methods compared to a predicate device.
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The sample size for the training set:
Not applicable. This is not an AI/software-as-a-medical-device submission; therefore, there is no training set.
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How the ground truth for the training set was established:
Not applicable. There is no training set mentioned in the document.
Summary of what is present in the document regarding acceptance criteria and studies:
The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Prime & Bond NT Dual Cure, K982394). The "acceptance criteria" in this context are implicit in the FDA's regulatory framework for 510(k)s, meaning the device must be as safe and effective as the predicate device.
The study or data proving this substantial equivalence is described as:
- Rationale for Substantial Equivalence:
- Shared similarities in use in the oral environment.
- Similar indications for use.
- Similar application methods.
- "Similar active constituents in similar concentrations."
- "Exact information regarding the material's constituents is found in Part 6: Specifications." (This indicates that the "study" is likely a comparison of material specifications and performance data, which is mentioned as being in "Part 7: Performance Data" but not provided in the extract).
The "study" here is not a clinical trial or an AI performance study, but a technical comparison of the material properties, composition, and intended use against a previously cleared device. The "acceptance criteria" are met if the FDA agrees that the similarities are sufficient to declare the new device substantially equivalent to the predicate, "without raising any new issues regarding safety and/or effectiveness."
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(0704
510(k) Summary of Safety and Effectiveness
CAO GROUP 4628 West Skyhawk Drive Sandy, UT 84070 Tel: 801.256.9282 Fax: 801.256.9287 www.caogroup.com Robert K. Larsen, Operations Director Preparation Date: January 29, 2007
APR 2 6 2007
Device Name:
| Trade Name: | Ascent Universal Adhesive |
|---|---|
| Common Name: | Dental adhesive |
| Product Classification: | Agent, Tooth Bonding, Resin (21 CFR 872.3200, ProductCode: KLE) |
Legally Marketed Predicate Devices for Substantial Equivalence:
- Prime & Bond NT Dual Cure, Manufactured by Dentsply International . 510(k) Number: K982394
Rationale for Substantial Equivalence:
The aforementioned device shares similarities for use in the oral environment for the purpose of adhering restorative materials to tooth structure. This device features similar indications for use and application methods to the predicate device.
Description of Submitted Device:
The Ascent Universal Adhesive is an ethanol-based composition containing a special formulation of resins to achieve an excellent bond to materials such as restorative composites, dentin, enamel, metals and porcelain. The composition is polymerized by means of a dental polymerization light source. Exact information regarding the material's constituents is found in Part 6: Specifications
Intended Uses of the Ascent Custom Fluoride Tray System:
Ascent Universal Adhesive is intended for all direct and indirect restorations where light cure is possible. It is indicated as an adhesive for: light cured restorative
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composites, Methacrylate resin cements, dentin, enamel, metal alloys and porcelain.
Technological Characteristics of Substantial Equivalence:
Both the submitted and predicate device are composed of similar substances, with similar active constituents in similar concentrations. Both have similar indications for use. Both have similar methods of application. Both are used in conjunction with dental restorative and preventative procedures.
... ..........................................................................................................................................................................
Performance Standards:
None
Performance Data
See Part 7: Performance Data
Conclusion
The Ascent Universal Adhesive is substantially equivalent to the aforementioned predicate device with regards to purpose of the device, general composition, methods of application, and indications for use without raising any new issues regarding safety and/or effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized representation of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert K. Larsen Operations Director CAO Group, Incorporated 4628 West Skyhawk Drive West Jordan, Utah 84084
APR 2 6 2007
Re: K070413
Trade/Device Name: Ascent Universal Adhesive Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: January 29, 2007 Received: February 13, 2007
Dear Mr. Larsen:
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 - Mr. Larsen
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" (21CFR Part 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.D.
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):
Device Name: Ascent Universal Adhesive
Indications For Use:
Ascent Universal Adhesive is indicated for direct bonding to:
- Dentin .
- Enamel .
- Composite .
- Porcelain .
- Metal ●
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
nesthesiology, General Hospital, ntrol, Dental Devices 13(k) Number:
Prescription Use OR X (Per 21 CFR 801.109)
Over-The-Counter Use
§ 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.