(219 days)
Not Found
No
The description focuses on the material composition and physical properties of a dental restorative composite, with no mention of AI or ML.
No
The device is a restorative material used for dental fillings, not a device that provides therapy or treatment for disease or injury.
No
This device is a restorative material used for dental fillings, not for diagnosing medical conditions. Its intended use is for direct and indirect restorations of cavities and veneers.
No
The device description clearly states it is a "light-cured hybrid dental restorative composite material," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for direct and indirect dental restorations (fillings, inlays, onlays, veneers). This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The device is a dental restorative composite material. Its function is to physically fill and restore tooth structure.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device is a material used for treatment and restoration within the mouth.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EBF
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.
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)
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.
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
§ 872.3690 Tooth shade resin material.
(a)
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.(b)
Classification. Class II.
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
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