SILKLINE SOFT RELINING KIT, MODEL 28-100100

K060844 · J. Morita USA, Inc. · EBI · Jun 6, 2006 · Dental

Device Facts

• Record ID: K060844
• Device Name: SILKLINE SOFT RELINING KIT, MODEL 28-100100
• Applicant: J. Morita USA, Inc.
• Product Code: EBI · Dental
• Decision Date: Jun 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SilkLine Soft Relining Kit is intended to be used as a denture relining, repairing, or rebasing resin.

Device Story

SilkLine Soft Relining Kit is a dental resin material used for relining, repairing, or rebasing dentures. It is intended for professional use by dentists in a clinical setting. The material is applied to the denture base to improve fit, comfort, or structural integrity. It functions as a restorative dental material to address denture-related issues. The device benefits patients by restoring proper denture function and comfort.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Denture relining, repairing, or rebasing resin. Class II device. Product code EBI. Regulation 872.3760.

Indications for Use

Indicated for use as a denture relining, repairing, or rebasing resin for patients requiring denture maintenance or adjustment.

Regulatory Classification

Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2006

J. Morita USA, Incorporated Mr. Howard Rowe Consultant 9 Mason Irvine, California 92618

Re: K060844

Trade/Device Name: SilkLine Soft Relining Kit Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: March 24, 2006 Received: March 28, 2006

Dear Mr. Rowe:

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.

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

## Page 2 - Mr. Rowe

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,

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

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

## Indications For Use Statement

| 510(k) Number (if known): | Not Assigned to date K060844 |
|---------------------------|------------------------------|
| Device Name: | SilkLine Soft Relining Kit |

Indications For Use:

The SilkLine Soft Relining Kit is intended to be used as a denture relining, repairing, or rebasing resin.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span></span> |
|-------------------------|---------------|
| OR (Per 21 CFR 801.109) | |
| Over-The-Counter Use | |

*Sign Here*

| of Anesthesiology, General Hospital, | |
|--------------------------------------|--|
| Lion Control, Dental Devices | |

| K Number: | K060841 |
|-----------|---------|
|-----------|---------|