SOLO ORTHO 3

K020502 · Sybron Dental Specialties, Inc. · DYH · May 1, 2002 · Dental

Device Facts

• Record ID: K020502
• Device Name: SOLO ORTHO 3
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: DYH · Dental
• Decision Date: May 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2

Intended Use

Solo Ortho 3 is designed to be used as an enhancing primer for labial and lingual orthodontic bonding.

Device Story

Solo Ortho 3 is a one-bottle, universal orthodontic bonding primer. It is applied by clinicians to tooth surfaces to facilitate the bonding of ceramic or metal brackets. The device is compatible with both chemical and light-cured adhesive systems. It functions as an interface to enhance bond strength between the tooth and the orthodontic bracket. It is used in clinical orthodontic settings.

Technological Characteristics

One-bottle, universal primer for orthodontic bonding. Compatible with chemical or light-cured adhesive systems. Class II device (21 CFR 872.3750).

Indications for Use

Indicated for use as an enhancing primer for labial and lingual orthodontic bonding of ceramic or metal brackets 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

• Solo Ortho 2 (Ormco Corporation)

Submission Summary (Full Text)

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K.030502

# SYBRON DENTAL SPECIALTIES

MAY 0-1 2002

# 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

Date Summary Prepared: February 2002

#### Device Name:

- Trade Name Solo Ortho 3 .
- Common Name Orthodontic Bonding Primer
- · Classification Name Bracket Adhesive Resin and Tooth Conditioner, per 21 CFR § 872.3750

# Devices for Which Substantial Equivalence is Claimed:

Ormco Corporation, Solo Ortho 2 .

#### Device Description:

The device is a one-bottle, universal primer for labial and lingual bonding of ceramic or metal brackets. Solo Ortho 3 can be used with either chemical or light cured adhesive systems.

### Intended Use of the Device:

The intended use of Solo Ortho 3 is as an enhancing primer for labial and lingual orthodontic bonding.

#### Substantial Equivalence:

Solo Ortho 3 is substantially equivalent to other legally marketed devices in the United States. Solo Ortho 3 functions in a manner identical to and is intended for the same use as the product Solo Ortho 2 cleared for marketing for Ormco Corporation.

> 1717 West Collins Avenue, Orange, CA 92887 800-537-7824 714-516-7400

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K020502

Trade/Device Name: Solo Ortho 3 Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: February 11, 2002 Received: February 14, 2002

Dear Ms. 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 Amendor ents, 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 the readeral F ocat, Drag, Drag, 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 (1 wr ), it an 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.

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.

Image /page/1/Picture/11 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

**MAY 01 2002**

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## Page 2 - Ms. Colleen Boswell

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 and insting (21 CFR 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 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,

Kichards

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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Section I

# Indications for Use Statement

Ver/ 3 - 4/24/96

Applicant: Ormco Corporation

| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-------------------------|
| 510(k) Number (if known): | K020502 |

Device Name: Solo Ortho 3

Indications For Use:

Solo Ortho 3 is designed to be used as an enhancing primer for labial and lingual orthodontic bonding.

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

| <strong>Labels</strong> | <strong>Values</strong> |
|-------------------------|-------------------------|
| 510(k) Number | K020502 |

(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)