HI-WAVE; POUR-PLUS

K011762 · Denplus, Inc. · EBI · Aug 23, 2001 · Dental

Device Facts

• Record ID: K011762
• Device Name: HI-WAVE; POUR-PLUS
• Applicant: Denplus, Inc.
• Product Code: EBI · Dental
• Decision Date: Aug 23, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HI-Wave is a 3 minutes microwave heat curing acrylic and Pour-Plus is a color stable auto-curing acrylic for use in the fabrication of complete or partial removable dentures.

Device Story

Hi-Wave and Pour-Plus are denture base acrylic resins used by dental professionals in laboratory settings. Hi-Wave is a microwave heat-curing acrylic; Pour-Plus is an auto-curing (self-curing) acrylic. Both materials are used to fabricate complete or partial removable dentures. The clinician processes these materials to form the denture base, providing a stable, color-stable prosthetic for the patient. These devices function as restorative dental materials to replace missing teeth and restore oral function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Denture base acrylic resins. Hi-Wave: microwave heat-curing system. Pour-Plus: auto-curing (self-curing) system. Materials are formulated for color stability and use in dental laboratory fabrication of removable prosthetics. Class II device, product code EBI.

Indications for Use

Indicated for the fabrication of complete or partial removable dentures in patients requiring prosthetic dental appliances.

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)

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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 symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is in black and white.

AUG 2 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Shuojia Donq Vice President Denplus Incorporated 1221 Labadie, Suite 205 Lonqueuil, Quebec CANADA

Re : K011762 Trade/Device Name: Hi-Wave; Pour-Plus Regulation Number: 872.3760 Regulatory Class: II Product Code: EBI Dated: June 4, 2001 Received: June 7, 2001

Dear Ms. Donq:

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 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). 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 (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. ਹੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS 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

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Page 2 - Ms. Dong

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 the Act for devices under the Electronic emoduct Siz or can 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 described in your sie in privalence of your device to a legally marketed predicate device results in a classification for your marketed predicato amits 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 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 ene promotion and [phone]. Also, please note "Misbranding by reference to the requlation entitled, premarket notification" (21CFR 807.97). Other qeneral 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,

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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## Koll762 510 (k) NUMBER (IF KNOWN):

DEVICE NAME: HI-Wave and Pour-Plus denture base acrylics

INDICATIONS FOR USE:

HI-Wave is a 3 minutes microwave heat curing acrylic and Pour-Plus is a color stable auto-curing acrylic for use in the fabrication of complete or partial removable dentures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1)

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(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_I < O)