SECURE RELINE/PICKUP MATERIAL

K021586 · Imtec Corp. · EBI · Jun 14, 2002 · Dental

Device Facts

• Record ID: K021586
• Device Name: SECURE RELINE/PICKUP MATERIAL
• Applicant: Imtec Corp.
• Product Code: EBI · Dental
• Decision Date: Jun 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SECURE is an acrylic resin used as a permanent hard relining / pickup material for complete and partial dentures.

Device Story

SECURE is an acrylic resin material used by dental professionals for the permanent hard relining or pickup of complete and partial dentures. The device functions as a restorative dental material to improve denture fit and stability. It is applied in a clinical dental setting by a dentist or dental technician. The material hardens to provide a durable, permanent interface between the denture base and the patient's oral tissues, facilitating improved comfort and function for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Acrylic resin material; used for permanent hard relining or pickup of complete and partial dentures; Class II device; Product Code EBI.

Indications for Use

Indicated for use as a permanent hard relining or pickup material for patients requiring complete or partial denture adjustments.

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 the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right. The profiles are stacked on top of each other, creating a sense of unity and collaboration.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 2002

Mr. J. Brad Vance Director of Regulatory Affairs IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401

Re: K021586

Trade/Device Name: SECURE Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: May 08, 2002 Received: May 14, 2002

Dear Mr. Vance:

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.

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Page 2 - Mr. J. Brad Vance

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 (OS) 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.

Patina Circuit/fa

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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## INDICATIONS FOR USE STATEMENT

KO21586 510 (K) Number (if known):

SECURE Device Name:

Indications For Use:

SECURE is an acrylic resin used as a permanent hard relining / pickup material for complete and partial dentures.

(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)

Susa Runses
(Division Sign-Off)
Division of Dental, Infection Control,

Owision of Dental, Infection Control, and General Hospital Devic 12001: 510(k) Number

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