VARIFLEX

K033632 · Great Lakes Orthodontics, Ltd. · EBI · Jan 21, 2004 · Dental

Device Facts

• Record ID: K033632
• Device Name: VARIFLEX
• Applicant: Great Lakes Orthodontics, Ltd.
• Product Code: EBI · Dental
• Decision Date: Jan 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Variflex™ is intended for the laboratory fabrication of dental appliances such as interocclusal splints and night guards.

Device Story

Variflex is a chemically cured soft dental acrylic used in dental laboratories for fabricating interocclusal splints and night guards. The material is processed by dental technicians to create custom-fit appliances. The device functions as a restorative/prosthetic material; it does not involve electronic inputs, algorithms, or software. It is intended for professional use in a laboratory setting to produce appliances that assist in managing dental conditions such as bruxism or occlusal issues. The final appliance is delivered to the patient by a clinician to provide therapeutic benefit through mechanical stabilization or protection of the teeth.

Clinical Evidence

Bench testing only. Evaluated for mechanical properties (hardness, water absorption, discoloration, physical property variation with temperature) and biocompatibility (MEM Elution test, mucous membrane irritation, Kligman Maximization test). Results indicated the material is non-cytotoxic, non-irritant, and a non-sensitizer.

Technological Characteristics

Chemically cured soft dental acrylic. Evaluated for hardness, water absorption, and thermal stability. Biocompatibility confirmed via MEM Elution, irritation, and sensitization testing.

Indications for Use

Indicated for laboratory fabrication of dental appliances, specifically interocclusal splints and night guards, for patients requiring such devices.

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.

Predicate Devices

• Clearsplint (Astron Dental Corporation)

Submission Summary (Full Text)

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K633632

Image /page/0/Picture/1 description: The image is a logo for Great Lakes Orthodontics. The logo features a black and white image of the United States with the Great Lakes highlighted in white. The words "GREAT LAKES" are written in a circular fashion above the image, and the word "ORTHODONTICS" is written in a circular fashion below the image.

JAN 2 1 2004

# Great Lakes Orthodontics, LTD.

An Employee Owned Company

Our Vision "Delight our customers. Respect and help our co-workers."

## 510(k) SUMMARY

#### CONTACT PERSON: Mr. Mark Lauren Great Lakes Orthodontics 800-828-7626 mlauren(a)greatlakesortho.com

DATE PREPARED: November 10, 2003

TRADE OR PROPRIETARY NAME: Variflex™ COMMON NAME: Dental acrylic, heat-softening acrylic CLASSIFICATION NAME: Denture relining, repairing or rebasing resin 872,3760 Product Code: EBI

PREDICATE DEVICE:

Clearsplint™ Astron Dental Corporation 815 Oakwood Road Unit G Lake Zurich, IL 60047 800-323-4144

#### DEVICE DESCRIPTION

Variflex 100 is a chemically cured soft dental acrylic. All components have been used in legally marketed devices or have been found to be safe for dental use.

INTENDED USE

Variflex " is intended for the laboratory fabrication of dental appliances such as interocclusal splints and night guards.

TECHNOLOGICAL CHARACTERISTICS COMPARED WITH PREDICATE DEVICE Variflex™ was evaluated as follows:

> Mechanical properties, Hardness, Water absorption, Discoloration Variation of physical properties with temperature

Variflex™ was also evaluated as follows: MEM Elution Test

non-cytotoxic Mucous membrane irritation non-irritant Kligman Maximization Test (NaCI) non-sensitizer

We conclude that the similarity in composition between Variflex " and the predicate device, as well as the performance data and biocompatibility results, supports the safety and effectiveness of Variflex™ for the indicated uses.

200 Cooper Avenue • P.O. Box 5111 • Tonawanda, New York 14151-5111 716-871-1161 · · 800-828-7626 · · · Fax [phone] e-mail: [e-mail] · · Website: www.greatlakesortho.com

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 2004

Mr. Mark Lauren Director of Research Great Lakes Orthodontics, Ltd. 200 Cooper Avenue Tonawanda, New York 14151-511

Re: K033632

Trade/Device Name: Variflex™ Heat Softening Acrylic Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: November 17, 2003 Received: December 01, 2003

Dear Mr. Lauren:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the enerosure/ to regary than of the Medical Device Amendments, or to devices that prior to May 26, 1770, the chactions and the provisions of the Federal Food, Drug, and Cosmetic liave been reclassince in accordance wof a premarket approval application (PMA). You may, ACt (Act) that do not require apple far the general controls provisions of the Act. The general therefore, mance the device, babyest er an irements for annual registration, listing of devices, good Controls provisions of clibeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device is classifica (see ao ro) into existing major regulations affecting your device can be may be subject to such additional volta of the 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

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## Page 2 – Mr. Mark Lauren

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r 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 premated 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 in you don't openite at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, and as reflecting or and mentitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may 1 at to in of 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,

Carl

Chiu S. Lin. PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

### 510(k) Number (if known): K033632

Great Lakes Orthodontics 200 Cooper Avenue Tonawanda, NY 14150

Device Name: Variflex™ heat softening acrylic

#### Indications for Use:

Variflex™ is intended for the laboratory fabrication of dental appliances such as splints and night guards.

Prescription Use (21 CFR Part 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K033632

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