(27 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is a physical bracket, not a software or imaging-based system typically associated with AI/ML in this context.
Yes.
The device is indicated for "orthodontic movement of natural teeth," which is a therapeutic purpose.
No
This device is indicated for orthodontic movement of teeth, which is a treatment function, not a diagnostic one. It is a "Rave Composite Bracket," which is a physical appliance used for treatment. While an orthodontist performs diagnostics before using such a device, the device itself is not a diagnostic tool.
No
The device description explicitly states "Rave Composite Bracket," which is a physical hardware component used in orthodontics. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "orthodontic movement of natural teeth". This is a mechanical action performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "Rave Composite Bracket". Brackets are physical components used in orthodontics to apply force to teeth.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on analysis of biological samples.
Therefore, this device falls under the category of a medical device used for treatment (orthodontic movement), not an in vitro diagnostic device used for testing biological samples.
N/A
Intended Use / Indications for Use
Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth. The devices are for Orthodontic Use Only, on the order of an Orthodontist.
Product codes
DYW
Device Description
Rave Composite Bracket
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
natural teeth, excluding mandibular bicuspid teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthodontist / Orthodontic Use Only
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 6 2005
Mr. Stephan Klamic Quality and Regulatory Affairs Manager Ortho Technology Incorporated 17401 Commerce Park Boulevard Tampa, Florida 33647
Re: K052714
Trade/Device Name: Rave Composite Bracket Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW Dated: September 27, 2005 Received: September 29, 2005
Dear Mr. Klamic:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your booken on of the device is substantially equivalent (for the indications for referenced above and nave acterially marketed predicate devices marketed in interstate commerce use stated in the energant from the Medical Device Amendments, or to devices that provision with 20, 1770, the chactions as the Federal Food, Drug, and Cosmetic liave been recidissified in accorpoval of a premarket approval application (PMA). You may, Act (Act) that ao not require approvato the general controls provisions of the Act. The general thereone, mance the de rios, babyer wents for annual registration, listing of devices, good controls provisions of willibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may of subject to suel additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 – Mr. Stephan Klamic
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that i Dr i boualite of a wouldevice complies with other requirements of the Act or that FDA has made a decemination and regulations and agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); an the Act 3 requiremones, moracturing practice requirements as set forth in the quality labeling (21 CFR Part 801), good need and if applicable, the electronic product radiation Systems (QB) rogar (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) I ms icher will anow you to oegin maing of substantial equivalence of your device to a legally prematication. - The PDF interior 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), please ir you desire specific acres at (240) 276-0115. Also, please note the regulation entitled, Colliact inc Office of Comphanes an (21 CFR Part 807.97). You may obtain other INnsolanding by reference to psystems in the Act from the Division of Small general intornation of your corporations in its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu S. Lin, PhD
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
2
INDICATIONS FOR USE
510(k) Number (if known): _
Device Name: Rave Composite Brackets
Indications for Use:
Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
The devices are for Orthodontic Use Only, on the order of an Orthodontist.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (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)
Susan Runser
f Anesthesiology, General Hospital, on Control, Dental Devices
Number: K052014
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