← Product Code [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE) · K070413 # ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028 (K070413) _CAO Group, Inc. · KLE · Apr 26, 2007 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K070413 ## Device Facts - **Applicant:** CAO Group, Inc. - **Product Code:** [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE.md) - **Decision Date:** Apr 26, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3200 - **Device Class:** Class 2 - **Review Panel:** Dental ## Intended 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. ## Device Story Ascent Universal Adhesive is an ethanol-based resin composition used in dental clinics by dentists. It functions as a bonding agent for direct and indirect restorations. The material is applied to tooth structure (dentin, enamel) or restorative materials (composites, metal alloys, porcelain) and polymerized using a dental light-curing source. The adhesive facilitates the attachment of restorative materials to the tooth, aiding in the structural integrity of dental repairs. ## Clinical Evidence No clinical data. Bench testing only. ## Technological Characteristics Ethanol-based resin composition. Polymerized via dental light-curing source. Designed for bonding to dentin, enamel, composites, metals, and porcelain. ## Regulatory 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. ## Predicate Devices - Prime & Bond NT Dual Cure ([K982394](/device/K982394.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K070413](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K070413) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com