EVOLVE

K033551 · Reliance Orthodontic Products, Inc. · DYH · Dec 16, 2003 · Dental

Device Facts

• Record ID: K033551
• Device Name: EVOLVE
• Applicant: Reliance Orthodontic Products, Inc.
• Product Code: DYH · Dental
• Decision Date: Dec 16, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fluoride-releasing, light-cured bracket bonding system in the oral cavity of dental patients.

Device Story

EVOLVE is a fluoride-releasing, light-cured, color-changing orthodontic adhesive paste. It is used by dental professionals to bond orthodontic brackets to enamel, porcelain, composite, or metal surfaces. The material is supplied in push syringes or syringe tips. Upon light curing, the paste provides high bond strength and prevents bracket fixation. The contrasting blue color assists the clinician in placement and cleanup. The device is intended for use in a clinical dental setting.

Clinical Evidence

Bench testing only. Biocompatibility testing was performed and the device was found to be non-toxic.

Technological Characteristics

Fluoride-releasing, light-cured, glass-filled, dimethacrylate-based composite adhesive. Highly viscous, smooth, tacky paste. Supplied in push syringes or syringe tips.

Indications for Use

Indicated for use as a fluoride-releasing, light-cured orthodontic bracket bonding system in the oral cavity of dental patients.

Regulatory Classification

Identification

A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.

Predicate Devices

• Light Bond with Fluoride (K895522)

Submission Summary (Full Text)

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# DEC 1 6 2003

Page 7-1

23551

### Section 7 SPECIAL 510 (k) SUMMARY

| 1. Applicant: | Reliance Orthodontic Products, Inc.<br>1540 W. Thorndale Ave<br>Itasca, IL 60143 | |
|-----------------|----------------------------------------------------------------------------------|--|
| Contact Person: | Benjamin Lichtenwalner<br>Ph. 847-534-6146<br>Fax [phone] | |
| Date Prepared: | November 7, 2003 | |

#### 2. Trade Name: EVOLVE

Common/Usual Name: Dental Orthodontic Adhesive Common/Usual Name: Donal Ormodonial Hancer.
Classification/Name: Class II per 21 CFR 872.3750/Bracket adhesive resin and tooth conditioner

- 3. Predicate (un-modified) Device: Light Bond with Fluoride, cleared under K895522 dated 12/7/1989
#### 4. Description of Applicant Device:

Description of Applicant Device.
EVOLVE is a fluoride-releasing, light-cured, color changing adhesiests who type of orthodontic bracket in bonding to any enamel, porcelain, composite or metal surfaces when properly conditioned. It is a highly filled, smooth, tacky paste that helps provent bracket fination and delivers maximum bond strength on curing. Its contrasting blue color facilitates the ease of placement in every in in mych denvers maximulli bond sirengin on cannig. To consuming one cored. The material is supplied in push syringes or syringe tips.

#### 5. Intended Use of Applicant Device:

Intended Use of Applicant Device.
EVOLVE is a fluoride-releasing, light-cured orthodontic bracket bonding to the wa EVOLVE is a finoride-teleasing, ingilt cared criticalently of EVOLVE is identical to the unmodified (predicate) device Light Bond with Fluoride.

#### 6. Technological Characteristics:

Technological Characteristics.
EVOLVE posses the same technological characteristics as the un-modified charge a side by aide Bond with Fluoride and has similar physical properties. Below is a table which shows a side-by-side comparison of the technological characteristics.

| Technological Characteristics | Evolve | Light Bond with Fluoride |
|---------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Intended use | Dental Bracket Adhesive | Dental Bracket Adhesive |
| Chemical Composition | Light cured, fluoride-releasing,<br>glass filled, Dimethacrylate-<br>based composite | Light cured, fluoride-releasing,<br>glass filled, Dimethacrylate-<br>based composite |
| Mechanical /physical properties | Highly viscous, smooth, tacky<br>paste. High bond strength | Highly viscous, smooth, tacky<br>paste. High bond strength |

EVOLVE was tested for biocompatibility and it was found to be non-toxic. It is concluded that he a light Pord information supplied in this submission has proven that EVOLVE is as safe and effective as Light Bond information supplied in this submission has proposed changes do not affect the safety and efficacy of the modified product, EVOLVE.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 2003

Reliance Orthodontic Products, Incorporation C/O Mr. Benjamin Lichtenwalner Regulatory Affairs Coordinator Bisco, Incorporation 1100 W. Irving Park Road Schaumburg, Illinois 60193

Re: K033551

Trade/Device Name: EVOLVE Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: December 03, 2003 Received: December 08, 2003

Dear Mr. Lichtenwalner:

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. Lichtenwalner

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/dsma/dsmamain.html

Sincerely yours,

Chus

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

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## Indications for Use

510(k) Number (if known): K033551

Device Name: EVOLVE

Indications For Use:

- 1. Fluoride-releasing, light-cured bracket bonding system in the oral cavity of dental patients.
Prescription Use ✓ AND/OR (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa R

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

510(k) Number: C633331

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