(465 days)
Not Found
No
The summary describes a physical orthodontic device made of polymers and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the "treatment of tooth malocclusion" and "to position teeth," which are therapeutic actions.
No
The device is indicated for the treatment of tooth malocclusion and preprosthetic orthodontic cosmetic movement, suggesting a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it "consists of dual laminated polymers," indicating a physical, hardware component (the aligner itself).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of tooth malocclusion and preprosthetic orthodontic cosmetic movement. This is a direct treatment applied to the patient's body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The device is a physical appliance (dual laminated polymers) designed to apply force to teeth.
- Anatomical Site: The device acts on teeth, which are part of the patient's body.
- Performance Studies: The performance studies described are related to the mechanical properties and function of the device in moving teeth, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
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 second molars). The NuBrace IRO is intended to position teeth by way of continuous gentle force.
Product codes
NXC
Device Description
The NuBrace IRO consists of dual laminated polymers that enhance patient comfort and move teeth at a longer, more gradual rate of tooth movement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.5470 Orthodontic plastic bracket.
(a)
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.(b)
Classification. Class II.
0
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: (202) 637-5794 · Facsimile: (202) 637-5910
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: (310) 273-0153
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
1
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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:
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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