DAMON 3 MODIFIED

K052477 · Ormco Corp. · DYW · Nov 30, 2005 · Dental

Device Facts

• Record ID: K052477
• Device Name: DAMON 3 MODIFIED
• Applicant: Ormco Corp.
• Product Code: DYW · Dental
• Decision Date: Nov 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of Damon 3 Modified is as a plastic orthodontic bracket that is designed for the movement of teeth during orthodontic treatment.

Device Story

Damon 3 Modified is a polycarbonate orthodontic bracket system for maxillary and mandibular teeth (second bicuspid to second bicuspid). Device features self-ligating mechanism and metal reinforcement integrated into molded plastic body to improve structural strength against metal slide over-travel and facilitate opening/closing. Used by orthodontists in clinical settings to apply forces for tooth movement. Benefits include improved mechanical reliability and ease of use during orthodontic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Polycarbonate orthodontic bracket; self-ligating design; metal reinforcement assembly integrated into molded plastic body; dimensions cover maxillary and mandibular teeth from second bicuspid to second bicuspid.

Indications for Use

Indicated for patients requiring orthodontic treatment to aid in the movement of teeth.

Regulatory Classification

Identification

An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.

Predicate Devices

• Damon 3 (K052477)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/18 description: The image shows the Sybron Dental Specialties logo with the text "SYBRON DENTAL SPECIALTIES" below it. Above the logo, the date "NOV 3 0 2005" is printed. To the left of the logo, the text "K 052477" is written in handwriting.

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: September 2005

## Device Name:

- Trade Name Damon 3 Modified .
- Common Name Plastic Orthodontic Bracket .
- Classification Name Bracket, Plastic, Orthodontic, per 21 CFR § 872.5470 .

# Devices for Which Substantial Equivalence is Claimed:

- Ormco Corporation, Damon 3 ●
## Device Description:

The device is a polycarbonate orthodontic bracket which will encompass maxillary and mandibular brackets from second bicuspid to second bicuspid. The Damon 3 Modified mandroum orders stemic and self-ligating qualities. The Damon 3 Modified bracket was appliance has bour acthe reinforcement of the metal assembly to the molded plastic body, to enhance the strength of the bracket against the over-travel of the metal slide and to improve the ease of its opening and closing mechanisms.

# Intended Use of the Device:

The intended use of Damon 3 Modified is as a plastic orthodontic bracket that is designed for the movement of teeth during orthodontic treatment.

## Substantial Equivalence:

Damon 3 Modified is substantially equivalent to other legally marketed devices in the Damon 3 Modified functions in a manner identical to and is intended for the same use as the original Damon 3 bracket that is currently manufactured by Ormco Corporation.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping human profiles facing to the right, with flowing lines beneath them that could represent water or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 2005

Ormco Corporation C/O Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K052477

Trade/Device Name: Damon 3 Modified Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW Dated: September 8, 2005 Received: September 12, 2005

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 Amendments, or to devices that have been reclassified in accordance with the provisions of / Intenditer, of to are, 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 approvisions of the Act. The general controls provisions of the Act include controls providents of an 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 Writ), it may be sacross 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.

{2}------------------------------------------------

Page 2 - Ms. 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 moun that 221 mm made statutes and regulations administered by other Federal agencies. or the Fet of any 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 instills (21 CF read in the quality systems (QS) regulation (21 CFR Part 820); and if roquicable, 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 premainverlent 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), 11 you dents 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 may overn 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/industry/support/index.html.

Sincerely yours,

Clive St. Rom

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

{3}------------------------------------------------

K052477

# Indications for Use

510(k) Number (if known):

Device Name: Damon 3 Modified

Indications For Use:

Damon 3 Modified is a polycarbonate bracket system intended to aid in the movement of patient's teeth during orthodontic treatment.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

antinana

AND/OR

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

THE RESEART PLACES OF CALLERS OF CALLERS OF A

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Susan Parmer |
|----------------|-----------------------------------------------|
| | Division of Anesthesiology, General Hospital, |
| | Infection Control, Dental Devices |
| 510(k) Number: | K052477 |

Page 1 of 1