BIO-POST DENTAL POST SYSTEM

K974649 · Advanced Aeromedical, Inc. · ELR · May 1, 1998 · Dental

Device Facts

• Record ID: K974649
• Device Name: BIO-POST DENTAL POST SYSTEM
• Applicant: Advanced Aeromedical, Inc.
• Product Code: ELR · Dental
• Decision Date: May 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3810
• Device Class: Class 1

Intended Use

The Bio-Post is a dental root canal post intended to be cemented into the root canal of a tooth to stabilized and support a restoration.

Device Story

Bio-Post is a dental root canal post; fabricated from continuous glass fibers in a vinyl ester matrix surrounding a surgical grade stainless steel wire. Device is radiopaque and available in standard sizes. Used by dentists in a clinical setting to stabilize and support dental restorations. The post is cemented into the root canal of a tooth. The composite material provides a lower modulus of elasticity and higher tensile properties compared to traditional metal posts, potentially improving mechanical compatibility with tooth structure.

Clinical Evidence

Bench testing only. Comparative analysis of tensile strength and modulus of elasticity performed against aluminum, titanium, and stainless steel posts. Biocompatibility testing of materials confirmed.

Technological Characteristics

Composite of continuous glass fibers in a vinyl ester matrix with a surgical grade stainless steel wire core. Radiopaque. Mechanical properties: lower modulus of elasticity and higher tensile strength than austenitic alloy/steel posts. Non-software device.

Indications for Use

Indicated for patients requiring stabilization and support of a dental restoration via a root canal post.

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

• austenitic alloy root canal posts (Essential Dental Systems)

Submission Summary (Full Text)

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K974649

Tru-Flex Post Systems, Inc. Bio-Post 510(k) Notification Attachment 1

# Bio-Post Dental Post System Summary of Safety and Efficacy

#### Submitter Information:

1998

MAY

Tru-Flex Post Systems, Inc. 438 Bay Ridge Parkway Brooklyn, NY 11209

# 510(k) Summary Prepared by:

Carolann Kotula Official Correspondent for Tru-Flex Post Systems c/o mdi Consultants, Inc. 55 Northern Boulevard Great Neck, NY 11021

| Phone: | [phone] |
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| Fax: | [phone] |

## Date 510(k) Summary Prepared:

December 9, 1997

Root Canal Post

Root Canal Post

## Name/Classification of the Device:

Classification Name:

Common Name:

Proprietary Name:

Classification:

Bio-Post Dental Post System

872.3810

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Identification of the Legally Marketed Device to which the Submitter Claims Equivalence: These devices are substantially equivalent to austenitic alloy root canal posts legally marketed by Essential Dental Systems.

Comparative Information: Tensile strength and modulus of elasticity of the Bio-Post was compared to aluminum, titanium, and stainless steel posts. The results show the Bio-Post has a lower modulus, and higher tensile properties than alloy and steel posts.

Description of the Subject Device: The Bio-Post is fabricated from a composite of medical grade continuous glass fibers specifically oriented in a vinyl ester matrix around a surgical grade stainless steel wire. The device is radiopaque, and will be available in standard sizes.

Intended Use of the Subject Device: The device is intended to be cemented into the root canal of a tooth to stabilize and support a restoration.

Technological Characteristics of the Subject Device: The material and material orientation of the Bio-Post is a technological characteristic more advanced than the traditional root canal posts made of austenitic alloys. This allow the Bio-Post to have a lower modulus, and higher tensile properties than alloy and steel posts.

Biocompatibility testing of the materials showed them to be biocompatible.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1998

Tru-Flex Post Systems Incorporated C/O Ms. Carolann Kotula Vice President RA/QA mdi Consultants, Incorporated 55 Northern Boulevard Great Neck, New York 11021

Re : K974649 Trade Name: Bio-Post Dental Post System Regulatory Class: I Product Code: ELR Dated: April 7, 1998 Received: April 8, 1998

Dear Ms. Kotula:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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): You-may; therefore; market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A --substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Kotula

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timot Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Tru-Post Systems, Inc. Bio-Post 510(k) Notification Attachment 3

510(k) Number (if known): K974649

Device Name: Tru-Flex Post Systems Inc., Bio-Post Dental Post System

Indications for Use:

The Bio-Post is a dental root canal post intended to be cemented into the root canal of a tooth to stabilized and support a restoration.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number

OR

Prescription Use
(per 21 CFR 801.109) √

Over the Counter Use