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.

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.

AI/ML Overview

Here's a breakdown of the information you requested, based on the provided text:

This submission is for a dental restorative composite material, not an AI-powered diagnostic device. Therefore, many of the requested categories (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable in this context. The provided text describes a 510(k) submission for a physical medical device (dental filling material) and focuses on demonstrating substantial equivalence to predicate devices through comparative bench testing and material safety.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Test Parameters)	Reported Device Performance (AXIOM)	Study Proving Acceptance
Diametral strength	Found to be similar to predicate devices / within acceptable range	Comparative bench testing against predicate devices (3M Z100 Restorative, Kerr Corporation Prodigy 4). The submission states: "This is further validated by the comparative bench test conducted; diametral strength, flexural strength, Young's modulus, shrinkage, and hardness."
Flexural strength	Found to be similar to predicate devices / within acceptable range	Comparative bench testing against predicate devices (3M Z100 Restorative, Kerr Corporation Prodigy 4).
Young's modulus	Found to be similar to predicate devices / within acceptable range	Comparative bench testing against predicate devices (3M Z100 Restorative, Kerr Corporation Prodigy 4).
Shrinkage	Found to be similar to predicate devices / within acceptable range	Comparative bench testing against predicate devices (3M Z100 Restorative, Kerr Corporation Prodigy 4).
Hardness	Found to be similar to predicate devices / within acceptable range	Comparative bench testing against predicate devices (3M Z100 Restorative, Kerr Corporation Prodigy 4).
Cytotoxicity	Non-cytotoxic	Testing for cytotoxicity. The submission states: "AXIOM has been tested for cytotoxicity and mutagenicity and were found to be non-cytotoxic and non-mutagenic."
Mutagenicity	Non-mutagenic	Testing for mutagenicity. The submission states: "AXIOM has been tested for cytotoxicity and mutagenicity and were found to be non-cytotoxic and non-mutagenic."

Key takeaway: The acceptance criteria for this device are based on demonstrating comparable physical and safety properties to existing, legally marketed predicate devices through specific bench tests.

Information Not Applicable to This Device (as it is not an AI/diagnostic device)

Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to samples of the material used in laboratory bench tests, not patient data for a diagnostic algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical material's properties is established through standardized laboratory measurements, not expert review of images or data.
Adjudication method for the test set: Not applicable. Laboratory test results are objective measurements.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for an AI diagnostic algorithm, not a dental filling material.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used: For the physical/safety tests, the ground truth is the objective measurement from the specified laboratory tests (e.g., a measured MPa for flexural strength). For claims of "similar to predicate," the ground truth is the established performance characteristics of the predicate devices.
The sample size for the training set: Not applicable. This is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary of the 510(k) process for AXIOM:

The manufacturer, Tri Dental Innovators, submitted AXIOM, a light-cured hybrid dental restorative composite, for 510(k) clearance. Their primary method of demonstrating safety and effectiveness was through showing substantial equivalence to existing predicate devices (3M Z100 Restorative and Kerr Corporation Prodigy 4). This was achieved by:

Component Comparison: Stating that all components of AXIOM are found in legally marketed predicate devices and share similar technological characteristics based on monomer chemistry.
Comparative Bench Testing: Conducting specific laboratory tests (diametral strength, flexural strength, Young's modulus, shrinkage, and hardness) to show that AXIOM performs comparably to the predicate devices.
Biocompatibility Testing: Demonstrating that AXIOM was non-cytotoxic and non-mutagenic.

The FDA reviewed this information and determined that AXIOM was substantially equivalent for its intended use (all classes of cavities), allowing it to be marketed.

Summary

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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 NguyenTri Dental Innovators
Address:	13902 West Street Unit CGarden 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

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.

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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.

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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

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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

Regulation Number and Section

§ 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.