ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS

K052245 · Lar Mfg., LLC · NJM · Sep 23, 2005 · Dental

Device Facts

• Record ID: K052245
• Device Name: ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS
• Applicant: Lar Mfg., LLC
• Product Code: NJM · Dental
• Decision Date: Sep 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The LAR Manufacturing, LLC Orthodontic Ceramic Brackets are indicated for orthodontic movement of teeth.

Device Story

Orthodontic ceramic brackets (Accent and Exceed series) designed for tooth movement; bonded to teeth using standard dental adhesives; connected via archwire to apply steady, gentle pressure; used in clinical dental settings by orthodontists; facilitates controlled tooth alignment; benefits patients by correcting malocclusions.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Translucent polycrystalline aluminum oxide (Al2O3, 99.9%). Form factor: Ceramic brackets with various slot sizes (Roth, Edgewise, Ricketts, Bio-Progressive/Hilgers). Energy source: Passive (mechanical pressure via archwire). Sterilization: Not specified.

Indications for Use

Indicated for orthodontic tooth movement in patients requiring corrective dental treatment.

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

• Mystic Orthodontic Ceramic Brackets (K042178)

Submission Summary (Full Text)

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K052245

| LAR Manufacturing, LLC | |
|------------------------------|-------------|
| Orthodontic Ceramic Brackets | SEP 23 2005 |

| 510(k)<br>Summary | This summary of 510(k) safety and effectiveness information is<br>being submitted in accordance with the requirements of 21 C.F.R.<br>\$ 807.92. | | | | |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Submission<br>Correspondant:<br>Phone:<br>Fax:<br>Contact:<br>e-mail: | Emergo Group Inc.<br>2454 McMullen Booth Road, Suite 427<br>Clearwater, FL 33759 USA<br>727-797-4727<br>727-797-4757<br>lan Gordon<br>Senior Vice President<br>[e-mail] | | | | |
| Submission<br>Sponsor: | LAR Manufacturing, LLC<br>6828 Commerce Ave.<br>Port Ritchey, FL 34668 | | | | |
| Date Prepared | August 5, 2005 | | | | |
| Name of device | Orthodontic Ceramic Brackets - Accent Series and Exceed<br>Series Ceramic Brackets | | | | |
| Classification<br>Names | Bracket, Ceramic, Orthodontic | | | | |
| Device<br>Classification | Regulatory Class: II<br>Product Code: NJM<br>Classification Panel: Dental<br>Regulation Number: 21 C.F.R. 872.5470 | | | | |

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## 510(k) Summary of Safety and Effectiveness

## LAR Manufacturing, LLC Orthodontic Ceramic Brackets

.

| Predicate<br>Device(s) | | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| 510(k)# | Device | Manufacturer |
| K042178 | Mystic Orthodontic<br>Ceramic Brackets | Dentsply International |
| Device<br>Description | LAR Manufacturing, LLC Ceramic Brackets are available if<br>the following prescriptions:<br>Exceed Series Brackets Roth .018" & .022" Slot Sizes Accent Series Roth .018" & .022" Slot Sizes; Edgewise .018" & .022" Slot Sizes; Ricketts .018" Slot Size; Bio-Progressive/Hilgers .018" & .022" Slot Sizes The Exceed Series and Accent Series Ceramic Brackets are<br>produced using Al2O3, translucent polycrystalline aluminum<br>oxide (99.9%). These Ceramic Brackets are bonded to the<br>teeth with commercially available materials and linked together by "archwire" that applies steady, gentle pressure to produce desired tooth movement. | |
| Indications | LAR Manufacturing, LLC Orthodontic Ceramic Brackets are<br>indicated for orthodontic movement of teeth. | |
| Technological<br>Characteristics | The function and performance of the LAR Manufacturing,<br>LLC Orthodontic Ceramic Brackets are identical to the<br>predicate device listed above. There is no difference in<br>fundamental scientific technology. The LAR Manufacturing,<br>LLC Orthodontic Ceramic Brackets are made of the same<br>material as the predicate device currently on the market and<br>has the same overall intended use. | |
| Conclusion | By definition, a device is substantially equivalent when the<br>device has the same intended use and the same<br>technological characteristics as the predicate device.<br>There are no major differences between the LAR<br>Manufacturing, LLC and the predicate device cited, and<br>therefore the LAR Manufacturing, LLC Orthodontic Ceramic<br>Brackets do not raise any questions regarding safety and<br>effectiveness.<br>The LAR Manufacturing, LLC Orthodontic Ceramic Brackets<br>as designed, are as safe and effective as the predicate<br>device, and the device is determined to be substantially<br>equivalent to the referenced predicate device currently on<br>the market. | |

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## 510(k) Summary of Safety and Effectiveness

## LAR Manufacturing, LLC Orthodontic Ceramic Brackets

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three horizontal lines that curve and converge, resembling a stylized human figure.

Public Health Service

SEP 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LAR Manufacturing, LLC C/O Mr. Ian P. Gordon Senior Vice President Emergo Group, Inc. 2454 McMullen Booth Road, Suite 427 Clearwater, Florida 33759

Re: K052245

Trade/Device Name: Accent Series™ Ceramic Brackets and Exceed Series™ Ceramic Brackets Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: August 12, 2005 Received: August 17, 2005

Dear Mr. Gordon:

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. Ian P. Gordon

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that 1 Dry o loualies of our device complies with other requirements of the Act or that FDA has made a decemination and Jaistered by other Federal agencies. You must comply with all reteral statures and regulations animals in the registration and listing (21 CFR Part 807); all the Act s requirements; morading; butacturing practice requirements as set forth in the quality labeling (21 CFR Part 807), E00 mixt 820); and if applicable, the electronic product radiation Systems (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) This letter witi anow you to oegin manetal equivalence of your device of your device to a legally premarked notheation: "The PDF Intently of our 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 If you desire specific darroliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general information on your responsibilities at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

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): K052245

Orthodontic Ceramic Brackets Device Name:

Indications for Use:

The LAR Manufacturing, LLC Orthodontic Ceramic Brackets are indicated for orthodontic movement of teeth.

Prescription Use
(Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ AND/OR (21 CFR 801 Subpart C)

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

Kein Muley

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D 510(k) Number:

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