CERAMIC BRACKETS

K110335 · Ortho Organizers, Inc. · NJM · May 19, 2011 · Dental

Device Facts

• Record ID: K110335
• Device Name: CERAMIC BRACKETS
• Applicant: Ortho Organizers, Inc.
• Product Code: NJM · Dental
• Decision Date: May 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These devices are intended for the correction of orthodontic malocclusions as diagnosed by a dentist or orthodontist. They are used to transmit and provide axial directional control to the kinetic energy from an orthodontic archwire, for movement of individual teeth for treatment.

Device Story

Ceramic brackets are single-use orthodontic components made of polycrystalline aluminum oxide; designed for direct bonding to teeth. Each bracket features an archwire slot, tie wings for ligature attachment, and a pad coated with microcrystalline aluminum oxide to enhance bonding. Brackets are used by orthodontists or dentists during comprehensive orthodontic treatment. The device functions by receiving kinetic energy from an orthodontic archwire and transmitting axial directional control to individual teeth to facilitate movement and correct malocclusions. The system includes various geometries tailored to specific teeth to ensure proper fit and force application.

Clinical Evidence

No clinical data. Substantial equivalence is based on descriptive comparison and performance testing.

Technological Characteristics

Material: 99.9% polycrystalline aluminum oxide. Pad coating: Irregular microcrystalline aluminum oxide. Form factor: Orthodontic brackets with archwire slots and tie wings. Connectivity: None. Sterilization: Non-sterile. Software: None.

Indications for Use

Indicated for patients requiring correction of malocclusions as diagnosed and overseen by trained orthodontic practitioners. Brackets are bonded directly to teeth to interface with archwires for force application. Intended for single use; non-sterile.

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

• Transcend Ceramic Brackets (K861965)
• Transcend Ceramic Brackets (K944286)
• Clarity Modified Ceramic Bracket (K062305)

Submission Summary (Full Text)

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K110335

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MAY 1 9 2011

# 5.510(k) Summary

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K110335

## 510k Summary

Device Name:

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Ceramic Brackets

Submitter's Name, address, telephone number, contact person, and date the summary was prepared:

| Submitter's Name: | Ortho Organizers Inc. |
|-----------------------------------|---------------------------------------------------------|
| Submitter's Address: | 1822 Aston Ave. Carlsbad, CA 92008 |
| Submitter's Telephone: | 760-448-8600 |
| | 760-448-8613 fax |
| Submitter's Contact:<br>Assurance | Foster Boop, Director of Regulatory Affairs and Quality |
| Email: | [e-mail] |
| | Ph. 760-448-8600 ext 146 |

Date 510(K) Summary Prepared: January 31, 2011

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

| Proprietary Name: | Undetermined |
|-----------------------|-------------------------------|
| Common or Usual Name: | Ceramic Brackets |
| Classification Name: | Bracket, Ceramic, Orthodontic |
| Classification Code: | NJM |

### Identification of Legally Marketed Device: (Device Equivalence)

| Proprietary Name: | Transcend Ceramic Brackets |
|-----------------------|-------------------------------|
| 510K Number: | K861965 |
| Common or Usual Name: | Ceramic Brackets |
| Classification Name: | Bracket, Ceramic, Orthodontic |
| Classification Code: | DYW |
| Device Manufacturer: | 3M-Unitek Corp. |

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| Proprietary Name: | Transcend Ceramic Brackets |
|-----------------------|----------------------------------|
| 510K Number: | K944286 |
| Common or Usual Name: | Ceramic Brackets |
| Classification Name: | Bracket, Ceramic, Orthodontic |
| Classification Code: | DYW |
| Device Manufacturer: | 3M-Unitek |
| Proprietary Name: | Clarity Modified Ceramic Bracket |
| 510K Number: | K062305 |
| Common or Usual Name: | Ceramic Brackets |
| Classification Name: | Bracket, Ceramic, Orthodontic |
| Classification Code: | NJM |
| Device Manufacturer: | 3M-Unitek |

#### Description of the Device:

The Ceramic Bracket line of products are single-use devices intended for use in conjunction with comprehensive orthodontics to control the movement of individual teeth.

These one-piece ceramic brackets are comprised of polycrystalline aluminum oxide. The general geometric composition of these devices is made of archwire slot, tie wings, and a pad (which provides a bonding surface). The archwire slot is a channel through the bracket used to engage the archwire. The tie wings are small hook shaped protrusion use as an anchor point for the ligatures work by tying the archwire into the archwire slot. The geometry of the pad is such that the bracket has a stable footprint. The pad is coated with aluminum oxide particles to facilitate bracket bonding with orthodontic adhesives.

These brackets are comprised of several geometries that vary from bracket to bracket, corresponding to the teeth they are intended for. These geometries contribute to the fit of the bracket to the tooth and also impart the axial control of the energy from the archwire.

#### Intended Use:

These devices are intended for the correction of orthodontic malocclusions as diagnosed by a dentist or orthodontist. They are used to transmit and provide axial directional control to the kinetic energy from an orthodontic archwire, for movement of individual teeth for treatment.

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Summary of the technological characteristics of the device compared to the predicate devices:

The Ortho Organizer Ceramic Bracket System is substantially equivalent to the 3M Unitek Ceramic Bracket System. Table 1 summarizes the technological characteristics of this equivalence:

Table 1.

| Product<br>Parameter | Bracket | Predicate Product:<br>3M Unitek Transcend<br>and Clarity* | Ortho Organizer's<br>ceramic brackets | Substantial<br>Equivalence Analysis |
|-----------------------------------------------------------|---------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| 510k Number | All | K861965, K944286,<br>K062305 | Pending | N/A |
| Intended use<br>per 872.5470 | All | intended to be<br>bonded to a tooth to<br>apply pressure to a<br>tooth from a flexible<br>orthodontic wire to<br>alter the tooth's<br>position | intended to be<br>bonded to a tooth to<br>apply pressure to a<br>tooth from a flexible<br>orthodontic wire to<br>alter the tooth's<br>position | Equivalent |
| Bracket Body<br>Material | All | 99.9% Polycrystalline:<br>aluminum oxide | 99.9% Polycrystalline<br>aluminum oxide | Equivalent |
| Pad Coating<br>Material | All | Irregular<br>Microcyrstalline<br>Aluminum Oxide | Irregular<br>Microcyrstalline<br>Aluminum Oxide | Equivalent |
| Biocompatibility | All | Yes | Yes | Equivalent |
| Single Use | All | Yes | Yes | Equivalent |
| Non-Sterile<br>packaging | All | Yes | Yes | Equivalent |
| Color coded<br>indicator for<br>bracket<br>identification | All | Yes | Yes, optional | Equivalent |

* A claim of Substantial Equivalence to the 3M Unitek Ceramic Bracket system is not made for the metal insert feature available in this product line. The Transcend Bracket, like the Ortho Organizer Ceramic Bracket, does not include this feature.

#### Conclusion:

The Ortho Organizer Ceramic Bracket System has the same intended use and similar technological characteristics as the predicate device. The minor differences in technological characteristics do not raise new types of safety and effectiveness questions. Descriptive and performance testing demonstrate substantial equivalence.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo.

MAY 1 9 2011

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Foster Boop Director of Regulatory Affairs and Quality Ortho Organizers, Incorporated 1822 Aston Avenue Carlsbad, California 92008-7603

Re: K110335

Trade/Device Name: Ceramic Brackets Impression Compound Regulation Number: 21 CFR 872.5470 Regulation Name: Plastic Orthodontic Bracket Regulatory Class: II Product Code: NJM Dated: January 31, 2011 Received: February 15, 2011

Dear Mr. Boop:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Boop

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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):

Device Name: Ceramic Brackets

Indications for Use:

These ceramic brackets will be used for correction of malocclusions as diagnosed and overseen by trained practitioners of orthodontics. These brackets will be directly bonded to teeth; will have interface with the archwire to direct applied forces. These devices are intended for single use only and are not delivered in a sterile state.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE).

Susan Rummer

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

510(k) Number: k110335