AXCEL FLOW

K063714 · Tri Dental Innovators · EBF · Jan 31, 2007 · Dental

Device Facts

• Record ID: K063714
• Device Name: AXCEL FLOW
• Applicant: Tri Dental Innovators
• Product Code: EBF · Dental
• Decision Date: Jan 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

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)

Device Story

AXCEL FLOW is a visible light-cure, resin-based flowable dental composite; composed of Bis-GMA resin, barium glass filler, and fumed silica. Used by dentists in clinical settings for restorative procedures. Material is applied to cavity preparations or as a base/liner; cured via visible light. Provides high strength and surface luster for minimally invasive restorations. Benefits include improved handling for conservative cavity preparations and repair of existing restorations.

Clinical Evidence

Bench testing only. Comparative analysis performed against predicate device for physical properties including diametral strength, flexural strength, Young's modulus, shrinkage, and hardness. Biocompatibility data (cytotoxicity, mutagenicity, Kligman maximization, and implantation tests) provided.

Technological Characteristics

Visible light-cure resin-based composite. Materials: Bis-GMA based resin, barium glass filler, fumed silica. Low-viscosity formulation. Class II device (Product Code EBF).

Indications for Use

Indicated for restoration of minimally invasive cavity preparations (occlusal pits and fissures), conservative anterior restorations (Classes III and IV), base/liner under direct restorations, and repair of fillings and veneers.

Regulatory Classification

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

• AXCEL Restorative Composite (K051931)
• Kerr Corporation Revolution 2 (K013647)

Submission Summary (Full Text)

{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".

K063714

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Contact Person: | Linda Nguyen<br>Tri Dental Innovators |
|----------------------|----------------------------------------------------------------------------------|
| Address: | 13902 West Street<br>Garden Grove, CA 92843 |
| Phone: | [phone] |
| Fax: | [phone] |
| | 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)<br>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 [phone]. 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 [phone] or [phone] 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

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