COSMOPOST

K972875 · Ivoclar North America, Inc. · ELR · Sep 17, 1997 · Dental

Device Facts

• Record ID: K972875
• Device Name: COSMOPOST
• Applicant: Ivoclar North America, Inc.
• Product Code: ELR · Dental
• Decision Date: Sep 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3810
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Cosmopost is intended to be used for preprosthetic stabilization of the tooth structure after endodontic treatment with largely intact crown, preprosthetic build up for damaged clinical crowns and thus resulting in loss of retention, using an indirect and direct method of attachment.

Device Story

Cosmopost is a dental post system used for preprosthetic stabilization and build-up of endodontically treated teeth. It supports both direct and indirect methods of attachment for damaged clinical crowns. The device is used by dental professionals in a clinical setting to restore structural integrity and retention for subsequent prosthetic restoration. It functions as a mechanical support structure within the root canal space.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental post system for endodontic stabilization and crown build-up. Mechanical device; no software or electronic components.

Indications for Use

Indicated for preprosthetic stabilization of tooth structure post-endodontic treatment in patients with largely intact crowns, and for preprosthetic build-up of damaged clinical crowns experiencing loss of retention.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 1997

Mr. Peter P. Mancuso Regulatory/Quality Assurance Manager Inoclar North America, Incorporated 175 Pineview Drive Amherst, New York 14228

Re : K972875 Trade Name: Cosmopost Requlatory Class: II Product Code: ELR Dated: July 31, 1997 Received: August 4, 1997

Dear Mr. Mancuso:

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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 miqht have under sections 531

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Page 2 - Mr. Mancuso

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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,

Patricia Cusimano Hor

Timothy A. Ulatowski 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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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Cosmopost Device Name: _

Indications For Use:

(Per 21 CFR 801.109)

Cosmopost is intended to be used for preprosthetic stabilization of the tooth structure after endodontic treatment with largely intact crown, preprosthetic build up for damaged clinical crowns and thus resulting in loss of retention, using an indirect and direct method of attachment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | Merl Shipps |
|---------------------------------------------------------------------|-------------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K972875 |

| Prescription Use | <div>✓</div> | OR | Over-The-Counter Use |
|------------------|--------------|----|----------------------|
|------------------|--------------|----|----------------------|

(Optional Format 1-2-96)