SNOWPOST, SNOWLIGHT

K012354 · Danville Materials, Inc. · ELR · Oct 10, 2001 · Dental

Device Facts

• Record ID: K012354
• Device Name: SNOWPOST, SNOWLIGHT
• Applicant: Danville Materials, Inc.
• Product Code: ELR · Dental
• Decision Date: Oct 10, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3810
• Device Class: Class 1

Intended Use

The Snowpost & Snowlight composite posts are intended for use by dentists to give retention for reconstruction of non-vital teeth.

Device Story

Snowpost & Snowlight are glass fiber composite root canal posts used by dentists to provide retention for the reconstruction of non-vital teeth. The device serves as a structural support for dental restorations in patients who prefer non-metal alternatives or have metal allergies. The posts are placed into the root canal to mechanically support the reconstruction. The device is a passive, mechanical component; it does not involve electronic processing, software, or automated decision-making.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing conducted per ISO 10993-5 (cytotoxicity) showed no evidence of cytotoxic response. Mechanical testing performed in conformance with ISO 3597-2-94 (Three-point Bending Standard) confirmed suitability for root canal post applications.

Technological Characteristics

Glass fiber composite root canal post. Mechanical support principle. Dimensions and material composition modified from predicates. Biocompatibility tested per ISO 10993-5. Mechanical strength validated per ISO 3597-2-94.

Indications for Use

Indicated for use wherever root canal posts are required, specifically for patients where metal posts are not preferred and/or where known metal allergies are of concern.

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

• Bisco UM Aesthetic Post (K945370)
• Coltene ParaPost Fiber White (K000311)
• Jeneric/Pentron FibreKor Post (K983266)
• Harald Nordin Glassix post (K003221)

Submission Summary (Full Text)

{0}------------------------------------------------

## OCT 1 0 2001

K 012354

## 510(k) Summary (As Required by 21 C.F.R. §807.92)

| Submitted by: | Craig Bruns<br>Vice President<br>Danville Materials, Inc.<br>2021 Omega Dr.<br>San Ramon, CA 94583<br>Phone [phone]<br>Fax [phone]<br>e-mail: [e-mail] | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Date of summary | July 20, 2001 | |
| Device name | Snowpost & Snowlight | |
| Common name | Glass fiber composite root canal post | |
| Classification names | Regulation Number<br>972.3810 | Classification Name<br>Dental root canal post |
| Predicate Device | The modified device is substantially equivalent to the previously cleared Bisco<br>UM Aesthetic Post (K945370), Coltene ParaPost Fiber White (K000311),<br>Jeneric/Pentron FibreKor Post (K983266), and Harald Nordin Glassix post<br>(K003221) devices. | |
| Modifications | The primary differences are minor changes to the material and dimensions. | |
| Intended Use | The modified device has the same intended use as the legally marketed<br>predicate devices herein referenced. The Snowpost & Snowlight composite<br>posts are intended for use by dentists to give retention for reconstruction of<br>non-vital teeth. | |
| Technological<br>Characteristics | The modified device has the same technological characteristics as the legally<br>marketed predicate device mechanically supporting reconstruction. | |
| Testing | ISO 10993-5 "Biological evaluation of medical devices - Tests for<br>Cytotoxicity: in vitro methods" was conducted and shows no evidence of a<br>cytotoxic response. Mechanical tests were conducted in conformance with ISO<br>3597-2-94 Three-point Bending Standard results showed the material to be<br>suitable for root canal posts | |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2001

Mr. Craig R. Bruns Vice President Danville Materials, Incorporated 2021 Omega Drive San Ramon, California 94583

Re: K012354

Trade/Device Name: Snowpost & Snowlight Regulation Number: 872.3810 Regulation Name: Root Canal Post Regulatory Class: I Product Code: ELR Dated: July 18, 2001 Received: July 25, 2001

Dear Mr. Bruns:

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.

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.

{2}------------------------------------------------

Page 2 - Mr. Bruns

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

K. Watoust

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

Enclosure

{3}------------------------------------------------

Page / of /

K012354 510(k) Number:

Device Name: Snowpost & Snowlight

Indications for use:

Snowpost & Snowlight posts are indicated for use wherever root canal posts are required Showpost & Showingin posts are mellor and/or where known metal allergies are of concern.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number _