(80 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of ceramic orthodontic brackets, with no mention of AI or ML.
Yes
The device is described as "designed to move teeth to improve their alignment" for "orthodontic movement on natural teeth surfaces," which constitutes a therapeutic action.
No
The device, CERAMIC BRACKETS Z, is described as being used for "orthodontic movement on natural teeth surfaces" and designed to "move teeth to improve their alignment." This indicates a therapeutic or corrective function, not a diagnostic one.
No
The device description clearly states that the device is composed of physical components (polycrystalline zirconia ceramic bracket, metal clip) that are bonded to teeth, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The CERAMIC BRACKETS Z are physical devices bonded to teeth to facilitate orthodontic movement. They are used directly on the patient's body, not for testing samples taken from the body.
- Intended Use: The intended use is for "orthodontic movement on natural teeth surfaces," which is a mechanical process applied to the patient, not a diagnostic test performed on a specimen.
The description clearly indicates a device used for physical manipulation of teeth within the mouth, which falls under the category of a general medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CERAMIC BRACKETS Z are indicated for orthodontic movement on natural teeth surfaces.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
The CERAMIC BRACKETS Z are designed to move teeth to improve their alignment.
The CERAMIC BRACKETS Z are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.
No accessories are marketed with the CERAMIC BRACKETS Z . The dental clinician is free to choose the bonding cement, supplemental ligatures and orthodontic wires for use with the brackets.
The CERAMIC BRACKETS Z are composed of a polycrystalline zirconia ceramic bracket, which includes an archwire slot and tiewings. The self-ligating CERAMIC BRACKETS Z have a metal clip so that no other ligation of the archwire is needed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
natural teeth surfaces
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals
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 testing was performed to ensure that the CERAMIC BRACKETS Z performance was achieved and validated, including shear bond tests and torque (fracture) tests.
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
510(k) Summary
per 21CFR807.92
CONTACT:
Mr. Jinichi Watanabe Manager, Legal Sec. TOMY, Inc. Tenko Bldg. 3-16-7 Midoricho, Fuchu City, Tokyo 183-0006 Japan
DATE PREPARED: November 2, 2012
TRADE OR PROPRIETARY NAME: CERAMIC BRACKETS Z
CLASSIFICATION NAME: Bracket, Ceramic, Orthodontic, 872.5470
PREDICATE DEVICES:
Clarity Advance Ceramic Brackets (K102803) In-Ovation C ceramic brackets (K060837)
DEVICE DESCRIPTION: The CERAMIC BRACKETS Z are designed to move teeth to improve their alignment.
The CERAMIC BRACKETS Z are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.
No accessories are marketed with the CERAMIC BRACKETS Z . The dental clinician is free to choose the bonding cement, supplemental ligatures and orthodontic wires for use with the brackets.
INTENDED USES: The CERAMIC BRACKETS Z are indicated for orthodontic movement on natural teeth surfaces.
TECHNOLOGICAL CHARACTERISTICS: The CERAMIC BRACKETS Z are composed of a polycrystalline zirconia ceramic bracket, which includes an archwire slot and tiewings. The self-ligating CERAMIC BRACKETS Z have a metal clip so that no other ligation of the archwire is needed.
Bench testing was performed to ensure that the CERAMIC BRACKETS Z performance was achieved and validated, including shear bond tests and torque (fracture) tests.
DEC 2 1 2012
1
The CERAMIC BRACKETS Z were not evaluated for biocompatibility because zirconia has a history of safe use in medical devices. All of the components have been used in legally marketed predicate CERAMIC BRACKETS Z.
The CERAMIC BRACKETS Z device is substantially equivalent in safety and effectiveness to the predicate device.
2
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a globe.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 21, 2012
TOMY, Inc. C/O Carolyn M. Primus, PhD Consultant Primus Consulting 7046 Owl's Nest Terrace Bradenton, FL 34203
Re: K123092
Trade/Device Name: Ceramic Brackets Z Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: September 28, 2012 Received: October 25, 2012
Dear Dr. Primus:
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. Ilsting 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.
3
Page 2 – Dr. Primus
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/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.
Kwame Ó. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K12 3 64 2
Device Name: CERAMIC BRACKETS Z
Indications For Use: CERAMIC BRACKETS Z are indicated for orthodontic movement on natural teeth surfaces.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
| Page 16 of 54 | |
|---|---|
| -- | --------------- |
| Susan Runner DDS, MA | |
|---|---|
| 2012.12.19 | |
| Premarket To:06:27:005'00' | |
| Tomy, Inc. | |
| CERAMIC BRACKETS Z | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K123092 |