(109 days)
Not Found
No
The description focuses on the mechanical properties and materials of the orthodontic brackets, with no mention of AI or ML for treatment planning, analysis, or any other function.
Yes
The device is intended for orthodontic movement of teeth, which is a therapeutic purpose to alter tooth position.
No
The device, orthodontic brackets, is used to apply pressure to teeth to alter their position, which is a treatment rather than a diagnostic function.
No
The device description clearly states that the device is a physical bracket made of Al2O3 that is bonded to teeth. This is a hardware device, not software.
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 teeth." This is a mechanical action performed directly on the patient's teeth.
- Device Description: The device is a bracket bonded to teeth to apply pressure via a wire. This is a physical device used for a therapeutic purpose within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve testing samples from the body.
The device is clearly a medical device used for orthodontic treatment, which is a form of therapy applied directly to the patient.
N/A
Intended Use / Indications for Use
The device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used only.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
The MACH BRACKETS are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position.
The modified orthodontic ceramic bracket has both aesthetic and self-ligating qualities. The modifications were aimed at facilitating easier orthodontic wire placement and removal through self-ligation and enhancing the bonding and debonding characteristics of the bracket.
The MACH BRACKETS is produced using Al2O3, translucent polycrystalline aluminum oxide (99.99%).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were performed.
Biocompatibility tests: In vitro cytotoxicity (ISO10993-5), Oral mucous membrane irritation test (ISO10993-10), BrdU' as a guideline for testing skin sensiztization (ISO10993-10). All tests passed.
The tests demonstrated that the device is as safe, as effective and performs in a substantially equivalent manner to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K120471 : Device: Orthodontic Ceramic Bracket
JUN - 4 2012
See 510(k) Summary, below.
Trade Name: . MACH BRACKETS , BRIGHT BRACKETS 1. Common Name: Orthodontic Ceramic Bracket Classification Name: Bracket, Ceramic, Orthodontic, product code NJM Product Code: NJM Requlation: 872.5470 Class of device : Class II.
-
- The legally marketed device to which we are claiming equivalence: Orthodontic Ceramic brackets (K090933 )
2. Description of device:
The MACH BRACKETS are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position.
The modified orthodontic ceramic bracket has both aesthetic and self-ligating qualities. The modifications were aimed at facilitating easier orthodontic wire placement and removal through self-ligation and enhancing the bonding and debonding characteristics of the bracket.
-
- Intended Use :
The device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used only.
- Intended Use :
-
- Technological Characteristics:
The MACH BRACKETS is produced using Al2O3, translucent polycrystalline aluminum oxide (99.99%).
- Technological Characteristics:
This MACH BRACKETS are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady, gentle produce desired tooth movement
-
- Performance: Bench tests were performed.
| Test Items | Test method | Tested by | Test results | |
|---|---|---|---|---|
| Biocompatibility | ||||
| Tests | In vitro cytotoxicity | ISO10993-5 | Dental Devices Testing | |
| & Evaluation Center | ||||
| Yeonsei University, | ||||
| College of Dentistry | Passed | |||
| Oral mucous membrane irritation | ||||
| test | ISO10993-10 | Passed | ||
| BrdU' as a guideline for testing skin | ||||
| sensiztization | ISO10993-10 | Passed |
Biocompatibility as follows;
The tests demonstrated that the device is as safe, as effective and performs in a substantially equivalent manner to the predicate device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
World Bio Tech Company, Limited C/O Mr. Peter Chung Correspondent 300 Atwood Street Pittsburgh, Pennsylvania 15213
JUN - 4 2012
Re: K120471
Trade/Device Name: Mach Brackets, Bright Brackets Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: April 28, 2012 Received: May 9, 2012
Dear Mr. Chung:
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.
2
Page 2 - Mr. Chung
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 vou 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 /ucm115809.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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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
3
Indications for Use Statement 4.
Indications for Use
510(k) Number (if known): K 12 O 4 71
Device Name: Orthodontic Ceramic Bracket.
Indications For Use:
The device is intended for orthodontic movement of teeth. It is used temporarily and is removed affer orthodontic treatment has been completed. The devices are intended to be single used only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 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 Rumsey
Page 1 of 1
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K120477