ENVISION

K032042 · Sybron Dental Specialties, Inc. · DYH · Sep 29, 2003 · Dental

Device Facts

• Record ID: K032042
• Device Name: ENVISION
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: DYH · Dental
• Decision Date: Sep 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2

Intended Use

EnVision is a light-cured orthodontic bonding adhesive that is designed to be used for the attachment of orthodontic appliances to teeth.

Device Story

EnVision is a chromatic, light-cured orthodontic bonding adhesive used by orthodontists to attach appliances to teeth. The paste is blue during application to enhance visibility and turns tooth-colored upon curing for aesthetic purposes. It features extended working time and rapid light-cure properties, allowing for immediate placement of active archwires. The adhesive is compatible with traditional etching, sealant procedures, and self-etching techniques. It is applied in a clinical setting to secure orthodontic hardware, facilitating effective tooth movement.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Light-cured resin orthodontic bonding adhesive. Chromatic (blue to tooth-colored) formulation. Compatible with traditional and self-etching systems. Class II device (21 CFR 872.3750).

Indications for Use

Indicated for the attachment of orthodontic appliances to teeth in patients requiring orthodontic treatment.

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

• 3M Unitek Dental Products Division, Transbond XT
• Reliance Orthodontic Products, Inc., Light-Bond

Submission Summary (Full Text)

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K032042

SEP 2 9 2003

Image /page/0/Picture/2 description: The image shows the logo for "sds Ormco SYBRON DENTAL SPECIALTIES". The logo has a curved line above the text. The text is in a bold, sans-serif font. The words "sds Ormco" are in a larger font than the words "SYBRON DENTAL SPECIALTIES".

Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person

June 2003 Date Summary Prepared:

## Device Name:

- Trade Name -- EnVision .
- Common Name Orthodontic Bonding Adhesive .
- · Classification Name Bracket Adhesive Resin and Tooth Conditioner, per 21 CFR & 872.3750

# Devices for Which Substantial Equivalence is Claimed:

- 3M Unitek Dental Products Division, Transbond XT .
- Reliance Orthodontic Products, Inc., Light-Bond .

### Device Description:

The device is a chromatic orthodontic bonding adhesive. This single paste bonding adhesive initially has a blue color that enhances ease of use. Upon curing, the final color takes on the shade of the tooth, rendering it unnoticeable. Envision has an extended working time and has a very fast light cure property that achieves high strength, allowing active archwires to be placed immediately. EnVision is compatible with traditional etching and sealant procedures, as well as newer self-etching techniques

### Intended Use of the Device:

The intended use of EnVision is as a light-cured orthodontic bonding adhesive that is designed to be used for the attachment of orthodontic appliances to teeth.

### Substantial Equivalence:

EnVision is substantially equivalent to other legally marketed devices in the United States. EnVision functions in a manner similar to and is intended for the same use as the products Transhond XT and Light-Bond cleared for marketing for 3M Unitek Dental Products Division and Reliance Orthodontic Products, Inc., respectively.

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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 eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

SEP 2 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Colleen Boswell Director, Corporation Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K032042

Trade/Device Name: Envision Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: June 23, 2003 Received: July 1, 2003

Dear Mr. Boswell:

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. Boswell

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,

Susan O'Runner

Susan Runner, DDS, MA Interim 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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Se :tion I

Indications for Use Statement

Verl 3 - 4/24/96

Ar plicant: Ormco Corporation

51.)(k) Number (if known): K 032042

Device Name: EnVision

Incications For Use:

EnVision is a light-cured orthodontic bonding adhesive that is designed to be used for the att ichment of orthodontic appliances to teeth.

M. Udell for MSR

Division Sian Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109) (Optional Format 1-2-96)