(48 days)
No
The device description and performance studies focus on the material properties and mechanical performance of a dental composite, with no mention of AI or ML.
No.
The device is a restorative dental composite material used for filling cavities and repairing teeth, which is a structural or cosmetic restoration, not a therapeutic treatment.
No
The device description indicates that AXCEL FLOW is a restorative dental composite material used for fillings and repairs, not for diagnosing medical conditions. The performance studies also focus on material properties relevant to restoration, not diagnostic accuracy.
No
The device description clearly states it is a "visible light cure resin-based flowable restorative dental composite material," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a material for restoring teeth (filling cavities, repairing fillings, etc.). This is a direct treatment or restoration of a physical structure within the body.
- Device Description: The description confirms it's a dental composite material used for restorations.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any such testing or analysis of biological samples.
Therefore, AXCEL FLOW is a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of AXCEL FLOW is for a base/liner under direct restorations and as a restoration of minimally invasive cavity preparations (including occlusal pits and fissures).
Indications For Use:
-
- Restoration of minimally invasive cavity preparations (including occuusal pits and fissures)
-
- Conservative anterior restorations (Classes III and IV)
-
- Base/liner under direct restorations
-
- Repair of fillings and veneers
Product codes
EBF
Device Description
AXCEL FLOW is a visible light cure resin-based flowable restorative dental composite material, comprised of a Bis-GMA based resin, barium glass filler and fumed silica, suitable for class III, class IV and class V restorations. It utilizes the same resin components found in AXCEL restorative composite. The cured product has high strength and a high surface luster.
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 for diametral strength, flexural strength, Young's modulus, shrinkage, and hardness.
AXCEL restorative composite (K051931) has been tested for cytotoxicity, mutagenicity, Kligman miximization test, and Implantation test and were found to be non-cytotoxic and non-mutagenic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AXCEL Restorative Composite (K051931), Kerr Corporation Revolution 2 (K013647)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for TDI. The logo has a curved line over the letters TDI. Under the letters TDI are the words "BRINGING INNOVATION".
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Contact Person: | Linda Nguyen
Tri Dental Innovators |
|----------------------|----------------------------------------------------------------------------------|
| Address: | 13902 West Street
Garden Grove, CA 92843 |
| Phone: | (714) 554-1170 |
| Fax: | (714) 554-2561 |
| | JAN 3 1 2002 |
| Date Prepared: | April 2006 |
| Trade Name: | AXCEL FLOW |
| Common Name: | Dental Restorative Composite |
| Classification Name: | Tooth Shade Resin Material (per 21 CFR § 872.3690) |
| Predicate Devices: | AXCEL Restorative Composite (K051931)
Kerr Corporation Revolution 2 (K013647) |
Device Description
AXCEL FLOW is a visible light cure resin-based flowable restorative dental composite material, comprised of a Bis-GMA based resin, barium glass filler and fumed silica, suitable for class III, class IV and class V restorations. It utilizes the same resin components found in AXCEL restorative composite. The cured product has high strength and a high surface luster.
Intended Use
The intended use of AXCEL FLOW is for a base/liner under direct restorations and as a restoration of minimally invasive cavity preparations (including occlusal pits and fissures)
Substantial Equivalence
AXCEL FLOW is a low viscosity version of its predicate device, AXCEL restorative composite (K051931). All the resin components of AXCEL FLOW are the same as AXCEL. This is further validated by the comparative bench test conducted; diametral strength, flexural strength, Young's modulus, shrinkage, and hardness. AXCEL restorative composite (K051931) has been tested for cytotoxicity, mutagenicity, Kligman miximization test, and Implantation test and were found to be non-cytotoxic and non-mutagenic. Based on the biocompatibility testing data and all the components in AXCEL FLOW, the prior use of the same components in legally marketed predicate devices and on performance data, we believe AXCEL FLOW is safe and effective for its intended use.
1
Public Health Service
Image /page/1/Picture/11 description: The image shows the logo for the Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an emblem that resembles an eagle or other bird with stylized wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Linda Nguyen Regulatory Affairs Specialist Tri Dental Innovators 13902 West Street Garden Grove, California 92843
JAN 3 1 2007
Re: K063714
Trade/Device Name: AXCEL FLOW Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 12, 2006 Received: December 14, 2006
Dear Ms. Nguyen:
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.
2
Enclosure
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 (OS) 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" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu S. Lin, PhD
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known):
K06 3714
Device Name: AXCEL FLOW
Indications For Use:
-
- Restoration of minimally invasive cavity preparations (including occuusal pits and fissures)
-
- Conservative anterior restorations (Classes III and IV)
- Base/liner under direct restorations
-
- Repair of fillings and veneers
Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR
- Repair of fillings and veneers
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 (ODE)
Susan Pearson
Anasthesiology, General Hospital n Control, Dental Devices
Page 1 of