FIBER-METAL POST

K060075 · Foremost Dental, LLC · ELR · Mar 30, 2006 · Dental

Device Facts

• Record ID: K060075
• Device Name: FIBER-METAL POST
• Applicant: Foremost Dental, LLC
• Product Code: ELR · Dental
• Decision Date: Mar 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3810
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Fiber-Metal Post is indicated for use as a root canal post. The post is cemented into the prepared root canal of a tooth to support a permanent restoration.

Device Story

Fiber-Metal Post functions as endodontic support; consists of central core wires with radially extending polymer bristles; available in various lengths, outer diameters, and configurations (straight or tapered). Device is used by dentists in clinical settings; cemented into prepared root canals to support permanent restorations. Provides mechanical reinforcement for endodontically treated teeth; improves fatigue cycle strength of final restoration. Clinical benefit includes enhanced structural integrity for teeth requiring restorative procedures.

Clinical Evidence

Bench testing only. Cyclic loading tests performed on restored teeth under occlusal and lateral loading conditions. Unrestored, caries-free endodontically-treated teeth served as controls. Results demonstrated acceptable fatigue cycle strength for the finished restoration.

Technological Characteristics

Root canal post consisting of central core wires with radially extending polymer bristles. Available in multiple lengths, outer diameters, and configurations (straight or tapered). Mechanical device; no energy source or software components.

Indications for Use

Indicated for use as a root canal post in patients requiring permanent tooth restoration; cemented into prepared root canals to provide structural support.

Regulatory Classification

Identification

A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.

Predicate Devices

• Snowpost (K012354)
• everStick™ Post (K030820)
• Fibiocore (K020431)

Submission Summary (Full Text)

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Foremost Dental, LLC 510(k) Premarket Notification (Traditional)

Image /page/0/Picture/1 description: The image shows a document with the number K060075 written at the top. Below the number, the text "P. 1 of 1" is visible, indicating that it is page 1 of a 1-page document. The text is in a simple, sans-serif font and appears to be a scanned or printed document. The document is likely related to some kind of official record or filing system.

January 3, 2006
Fiber-Metal Post

MAR 30 2006

| Trade Name: | Foremost Fiber-Metal Post |
|------------------------|----------------------------------------------------------------------------------------------------|
| 510(k) Sponsor: | Foremost Dental, LLC<br>242 South Dean Street<br>Englewood, NJ 07631<br>FDA Registration # 2244812 |
| Contact: | George Wolfe, Product Development Manager |
| Device Generic Name: | Root canal post |
| Device Classification: | Class I |
| Classification Number: | 21 CFR 872.3810 |
| Product Code: | 76 ELR |

#### Predicate Devices:

The Foremost Fiber-Metal Post is substantially equivalent to several currently marketed root canal posts:

| Product Name | 510(k) # | 510(k) Sponsor |
|-----------------|----------|--------------------------|
| Snowpost | K012354 | Danville Materials, Inc. |
| everStick™ Post | K030820 | Stick Tech, Ltd. |
| Fibiocore | K020431 | Anthogyr |

## Indications for Use:

The Fiber-Metal Post is indicated for use as a root canal post. The post is cemented into the prepared root canal of a tooth to support a permanent restoration.

## Product Description:

The Fiber-Metal Post consists of central core wires twisted around polymer bristles that extend radially from the core. The post will be available is several sizes (length and OD as measured over the fibers) and configurations based on bristle arrangement (straight or tapered).

## Safety and Performance:

Performance testing for the Fiber-Metal Posts consisted of a cyclic loading test on teeth restored using the post. Both occlusal and lateral loading was evaluated. Unrestored, caries-free endodontically-treated teeth served as the control. The results of this test demonstrated that the Foremost Fiber-Metal Post, when used as directed in the device labeling, results in an acceptable fatique cycle strength for the finished restoration.

## Conclusion:

Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Fiber-Metal Post has been shown to be safe and effective for its intended use.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 2006

Foremost Dental, LLC C/O Ms. Pamela Papineau Consultant Delphi Medical Device Consulting 5 Whitcomb Avenue Ayer, Massachusetts 01432

Re: K060075

Trade/Device Name: Fiber-Metal Post Regulation Number: 872.3810 Regulation Name: Root Canal Post Regulatory Class: I Product Code: ELR Dated: January 3, 2006 Received: January 11, 2006

Dear Ms. Papineau:

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.

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Page 2 -Ms. Papineau

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 (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) 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" (21CFR Part 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.

Chin Lin, Ph.D.

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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Foremost Dental, LLC 510(k) Premarket Notification (Traditional)

510(k) Number (if known): K060075

Device Name: Fiber-Metal Post

# Indications for Use:

The Fiber-Metal Post is indicated for use as a root canal post. The post is cemented into the prepared root canal of a tooth to support a permanent restoration.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-the -Counter Use (21 CFR 807 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runge

As General Manager

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