NUBRACE INVISIBLE REMOVABLE ORTHODONTICS

K073121 · Nubrace, Inc. · NXC · Feb 12, 2009 · Dental

Device Facts

• Record ID: K073121
• Device Name: NUBRACE INVISIBLE REMOVABLE ORTHODONTICS
• Applicant: Nubrace, Inc.
• Product Code: NXC · Dental
• Decision Date: Feb 12, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuBrace IRO is indicated for the treatment of tooth malocclusion and for pre-prosthetic orthodontic cosmetic movement in patients with permanent dentition (i.e., all second molars). The NuBrace IRO is intended to position teeth by way of continuous gentle force.

Device Story

NuBrace IRO is an invisible removable orthodontic stint; designed to position teeth via continuous gentle force. Device consists of dual-laminated polymers; features softer inner layer bonded to traditional polycarbonate outer shell. Designed for patient comfort; provides gradual tooth movement. Used by patients under professional guidance; intended for permanent dentition. Output is physical force applied to teeth to achieve alignment. Benefits include improved comfort and controlled, gradual orthodontic correction.

Clinical Evidence

Bench testing only. In vitro testing demonstrated that the dual-laminated polymer structure allows for a longer duration of action and improved patient comfort compared to traditional single-layer designs. Observed tooth movement was consistent with expected performance.

Technological Characteristics

Dual-laminated polymer orthodontic stint. Consists of a softer inner layer laminated to a polycarbonate outer shell. Form factor is a removable appliance. Principle of operation is mechanical force application for tooth positioning.

Indications for Use

Indicated for treatment of tooth malocclusion and pre-prosthetic orthodontic cosmetic movement in patients with permanent dentition (all second molars).

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

• Align Technology, Inc.'s Align System (K981095)

Submission Summary (Full Text)

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Ko73121

FEB 1 2 2009

# 510(k) SUM MARY

# NuBrace Inc.'s NuBrace Invisible Removable Orthodontics

# Submitter's Name, Address, Telephone Number , Contact Person and Date Prepared

Jonathan S. Kahan, Esq. Hogan and Hartson LLP Columbia Square 555 Thirteenth Street, NW Washington DC, 20004 Phone: [phone] · Facsimile: [phone]

Date Prepared: November 5, 2007

# Name of Device and Name/Address of Sponsor

NuBrace Invisible Removable Orthodontics

Tom Kalili, D.M.D. NuBrace, Inc. 416 N. Bedford Drive Suite 307 Beverly Hills, CA, 90210 Phone: [phone]

### Common or Usual Name

Invisible Removable Orthodontic Stint

#### Classification Name

Preformed Tooth Positioner

### Predicate Device

Align Technology, Inc.'s Align System (K981095)

#### Intended Use / Indications for Use

The NuBrace IRO is indicated for the treatment of tooth malocclusion and for preprosthetic orthodontic cosmetic movement in patients with permanent dentition (i.e., all

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second molars). The NuBrace IRO is intended to position teeth by way of continuous gentle force.

# Technological Characteristics

The NuBrace IRO consists of dual laminated polymers that enhance patient comfort and move teeth at a longer, more gradual rate of tooth movement.

## Performance Data

In vitro testing has demonstrated that laminating a softer layer onto the traditional polycarbonate outer shell allows for a longer duration of action. In addition, the softer layer allows for more patient comfort during wear. In all instances, NulBrace IRO functioned as intended and the tooth movement observed was as expected.

### Substantial Equivalence

NuBrace IRO is as safe and effective as the predicate device. NuBrace IRO has similar intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between NuBrace IRO and its predicate device raise no new issues of safety or effectiveness. Thus, NuBrace IRO is substantially equivalent.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, clutching a staff with a snake wrapped around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NuBrace IRO C/o Mr. Jonathan S. Kahan Hogan and Hartson, LLP 555 Thirteenth Street, NW Columbia Square Washington, District of Columbia 20004

Re: K073121 .

> Trade/Device Name: NuBrace IRO Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NXC Dated: February 10, 2009 Received: February 10, 2009

Dear Mr. Kahan:

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.

FEB 1 2 2009

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. Kahan

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 vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely vours.

Anthony 49, Austin, Tex

Ginette Y. Michaud, M.D. Acting 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 Statement

510(k) Number (if known):

Device Name: NuBrace IRO

Indications for Use:

K073121

The NuBrace IRO is indicated for the treatment of tooth malocclusion and for pre-prosthetic orthodontic cosmetic movement in patients with permanent dentition (i.e., all second molars). The NuBrace IRO is intended to position teeth by way of continuous gentle force.

Prescription Use x (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runore

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

510(k) Number: K073122

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