(73 days)
Unclear, K091001
No
The summary describes a dental adhesive and its intended use, composition, and polymerization method. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the chemical and physical properties of the adhesive.
No
The device is an adhesive used for bonding dental materials, not to treat or cure a disease or condition in the patient.
No
The provided text describes the device as an adhesive for restorations, indicating it is a therapeutic or restorative device, not one used for diagnosis. There is no mention of it being used to detect, monitor, or identify a condition.
No
The device is a chemical composition (adhesive) that is polymerized by a light source, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an adhesive for bonding dental materials (composites, cements, dentin, enamel, metal, porcelain) in direct and indirect restorations. This is a therapeutic and restorative function, not a diagnostic one.
- Device Description: The description details the chemical composition and polymerization method, consistent with a dental adhesive.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (blood, tissue, etc.) to provide information about a disease, condition, or state of health.
- Anatomical Site: The anatomical site is the oral environment (tooth structure), which is where the adhesive is applied directly for treatment.
- Intended User/Care Setting: Dental professionals in dental procedures are the intended users, consistent with a dental restorative material.
IVD devices are used to perform tests on samples taken from the human body to diagnose or monitor medical conditions. This device's function is to bond materials within the mouth for restorative purposes.
N/A
Intended Use / Indications for Use
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
Product codes
KLE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral environment (inferred from use with tooth structure, dentin, enamel)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
(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, Product |
| Code: 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
1
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.
2
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.
3
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
4
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