← Product Code [EBF](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF) · K051931 # AXCEL (K051931) _Tri Dental Innovators · EBF · Feb 17, 2006 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K051931 ## Device Facts - **Applicant:** Tri Dental Innovators - **Product Code:** [EBF](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF.md) - **Decision Date:** Feb 17, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3690 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use The intended use of AXIOM is for all classes of cavities. ## Device Story AXIOM is a light-cured hybrid dental restorative composite material. It consists of Bis-GMA based resin, barium glass filler, and fumed silica. The device is used by dental professionals in a clinical setting for dental fillings and restorations. The material is applied to the tooth cavity and light-cured to achieve high surface luster, strength, and wear resistance. It serves as a restorative material for both direct and indirect dental procedures, benefiting patients by repairing tooth structure and restoring function. ## Clinical Evidence Bench testing only. Comparative performance data provided for diametral strength, flexural strength, Young's modulus, shrinkage, and hardness. Biocompatibility testing (cytotoxicity and mutagenicity) performed with non-cytotoxic and non-mutagenic results. ## Technological Characteristics Light-cured hybrid dental restorative composite. Composition: Bis-GMA based resin, barium glass filler, and fumed silica. Form factor: restorative material for direct/indirect use. No software or electronic components. ## Regulatory Identification Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth. ## Predicate Devices - 3M Z100 Restorative ([K920425](/device/K920425.md)) - Kerr Corporation Prodigy 4 ([K990898](/device/K990898.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}------------------------------------------------ KOS1931/ Image /page/0/Picture/1 description: The image shows the text "FEB 17 2006" at the top. Below this text is a logo that appears to be for "TDI". The text "BRINGING INNOVATION" is located below the logo. The logo has a curved line above the letters "DI". ## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS | Contact Person: | Linda Nguyen
Tri Dental Innovators | |----------------------|-----------------------------------------------------------------------| | Address: | 13902 West Street Unit C
Garden Grove, CA 92843 | | Phone: | (714) 651-4163 | | Fax: | (714) 554-2561 | | Date Prepared: | July 2005 | | Trade Name: | AXIOM | | Common Name: | Dental Restorative Composite | | Classification Name: | Tooth Shade Resin Material (per 21 CFR § 872.3690) | | Predicate Devices: | 3M Z100 Restorative (K920425)
Kerr Corporation Prodigy 4 (K990898) | #### Device Description AXIOM is a light-cured hybrid dental restorative composite material, comprised of a Bis-GMA based resin, barium glass filler and fumed silica, suitable for dental filings. The cured product has a high surface luster, high strength and good wear resistance. ### Intended Use The intended use of AXIOM is for all classes of cavities. ### Substantial Equivalence All components of AXIOM are found in legally marketed predicate devices, which share similar technological characteristics that are based on monomer chemistry. This is further validated by the comparative bench test conducted; diametral strength, flexural strength, Young's modulus, shrinkage, and hardness. AXIOM has been tested for cytotoxicity and mutagenicity and were found to be non-cytotoxic and non-mutagenic. Based on the components in AXIOM, the prior use of the same components in legally marketed predicate devices and on performance data, we believe AXIOM is safe and effective for its intended use. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of three human profiles facing right, stacked vertically. The profiles are stylized with flowing lines. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the design. Public Health Service FEB 1 7 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Linda Nguyen Regulatory Affairs Tri Dental Innovators 13902 West Street, Unit C Garden Grove, California 92843 Re: K051931 Trade/Device Name: AXIOM Regulation Number: 872.3670 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: EBF Dated: February 6, 2006 Received: February 7, 2006 Dear Ms. Nguyen: We have reviewed your Section 510(k) premarket notification of intent to market the device we navere reviewed younve 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 mendments, or to devices that have been reclassified in accordance with the provisions of / Intendinents, or to active act (Act) that do not require approval of a premarket the Federal Food, Drag, Drag, therefore, market the device, subject to the general approvin application (s. The general controls provisions of the Act include controls providents of an 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 (1 writ), it hay be 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. {2}------------------------------------------------ Page 2 - Ms. Nguyen Please be advised that FDA's issuance of a substantial equivalence determination docs not I least that FDA has made a determination that your device complies with other requirements moun that I D7 may made statutes and regulations administered by other Federal agencies. or the Act of ally I outeral but is requirements, including, but not limited to: registration 1 ou must comply with art 807); labeling (21 CFR Part 801); good manufacturing practice allu histing (21 CF Real 807), assists (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) I mis letter will and in yourse bogan finding of substantial equivalence of your device to a premaired predicated 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), 11 you desire is 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 may obtain 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 yours. Susan Runpe 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known): K051931 Device Name: AXIOM Indications For Use - For direct restorations, for use in all classes of cavities, including veneers and incisal edge repairs. - For indirect anterior and posterior restorations, including inlays, onlays, and veneers. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C: (Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODIE) Susan Runge C. O. K. S Page 1 of --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K051931](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K051931) **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