(56 days)
Not Found
No
The summary describes a dental adhesive system with a chemical composition and polymerization process, with no mention of AI or ML technologies.
No
The device is an adhesive system used for bonding and desensitizing tooth structure, which is a restorative and protective function rather than a therapeutic one that treats or cures a disease or condition.
No
The device is an adhesive system used for bonding and desensitizing dental structures and materials, not for diagnosing diseases or conditions.
No
The device description clearly states it is an "ethanol-based composition containing a special formulation of resins," which is a physical substance, not software. It also mentions being "polymerized by means of a dental polymerization light source," indicating interaction with hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes direct bonding to and desensitizing of dental structures and materials. This is a direct treatment applied to the patient's body (or materials within the oral cavity), not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a chemical composition that is polymerized by light. This is consistent with a dental adhesive used in restorative procedures, not a diagnostic test.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays for testing
Therefore, the Ascent Bond Universal Adhesive System is a dental device used for bonding and desensitizing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ascent Bond Universal Adhesive System is indicated for direct bonding to and desensitizing of dentin and enamel, and direct bonding to composite, porcelain, and base metals.
Product codes (comma separated list FDA assigned to the subject device)
KLE, LBH
Device Description
The Ascent Bond 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
Not Found
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)
See Part 7: Performance Data
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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
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, Regulatory Affairs Manager Preparation Date: August 14, 2009
OCT 21 2009
Device Name:
| Trade Name: | Ascent Bond Universal Adhesive System |
|---|---|
| Common Name: | Dental adhesive |
| Product Classification: | Agent, Tooth Bonding, Resin (21 CFR 872.3200, Product Code: KLE) |
Legally Marketed Predicate Devices for Substantial Equivalence:
- Ascent Universal Adhesive, Manufactured by CAO Group, Inc. . 510(k) Number: K070413
- Gluma Comfort Bond + Desensitizer, Manufactured by Heraeus Kulzer, Inc. 0 510(k) Number: K992292
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, ingredients, and application methods to the predicate devices.
Description of Submitted Device:
The Ascent Bond 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
1
Intended Uses of the Ascent Bond Universal Adhesive System:
Ascent Bond Universal Adhesive System is indicated for direct bonding to and desensitizing of dentin and enamel, and direct bonding to composite, porcelain, and base metals.
Technological Characteristics of Substantial Equivalence:
Both the submitted and predicate devices 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 Bond Universal Adhesive System 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 seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Robert K. Larsen Regulatory Affairs Manager CAO Group, Incorporated 4628 West Skyhawk Drive West Jordan, Utah 84084
OCT 2 1 2009
Re: K092616
Trade/Device Name: Ascent Bond Universal Adhesive System Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE and LBH Dated: August 14, 2009 Received: August 26, 2009
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
ht far
Susan Runner, D.D.S., M.A. Acting 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 Bond Universal Adhesive System
Indications For Use:
Ascent Bond Universal Adhesive System is indicated for direct bonding to and desensitizing of dentin and enamel, and direct bonding to composite, porcelain, and base metals.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
X OR
Keen Muley for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Over-The-Counter Use
510(k) Number:
2-1