IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR

K991996 · Denplus, Inc. · EBI · Sep 8, 1999 · Dental

Device Facts

• Record ID: K991996
• Device Name: IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR
• Applicant: Denplus, Inc.
• Product Code: EBI · Dental
• Decision Date: Sep 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IMPACT-PLUS, IMPACT-20, DP97, DP97-20_ are heat-cure acrylics for complete and partial denture fabrication. DP-POUR is auto-cure acrylic for complete and partial denture fabrication. DP-REPAIR is auto-cure acrylic for denture repair.

Device Story

Device family consists of acrylic resin materials for dental prosthetics. Impact-Plus, Impact-20, DP97, and DP97-20 are heat-cure acrylics used by dental professionals for complete and partial denture fabrication. DP-Pour is an auto-cure acrylic for denture fabrication; DP-Repair is an auto-cure acrylic for denture repair. Materials are processed in dental laboratory settings by technicians or dentists. Final outputs are custom-fabricated or repaired dental appliances. Benefits include restoration of oral function and aesthetics for patients requiring dentures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Acrylic resin dental materials. Heat-cure (Impact-Plus, Impact-20, DP97, DP97-20) and auto-cure (DP-Pour, DP-Repair) formulations. Intended for dental laboratory fabrication and repair of dentures.

Indications for Use

Indicated for fabrication of complete and partial dentures (heat-cure acrylics: Impact-Plus, Impact-20, DP97, DP97-20; auto-cure acrylic: DP-Pour) and for denture repair (auto-cure acrylic: DP-Repair).

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 logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 8 1999

Shoujia Dong, Ph.D. Vice President DenPlus, Incorporated 4235 Beaconsfield Montreal, Quebec, Canada H4A 2H4

K991996 Re : Impact Plus, Impact-20, DP97, DP97-20, DP-Pour Trade Name: and DP-Repair II Regulatory Class: Product Code: EBI Dated: August 12, 1999 Received: August 20, 1999

Dear Dr. Dong:

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 Requlations, Title 21, Parts 800 to 895. ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation 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

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

Page 2 – Dr. Dong

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 (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 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

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

Enclosure

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

Page _1_ of _1

# 510 (k) NUMBER (IF KNOWN) : K991996

### IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR DEVICE NAME : and DP-REPAIR

# INDICATIONS FOR USE :

IMPACT-PLUS, IMPACT-20, DP97, DP97-20_ are heat-cure acrylics for complete and partial denture fabrication. DP-POUR is auto-cure acrylic for complete and partial denture fabrication. DP-REPAIR is auto-cure acrylic for denture repair.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <span style="text-decoration: overline;">✓</span> | OR | Over-The-Counter-Use<br>(Optional Format 1) |
|------------------------------------------|---------------------------------------------------|----|---------------------------------------------|
|------------------------------------------|---------------------------------------------------|----|---------------------------------------------|

Susan Rusan

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