(32 days)
Not Found
No
The device description focuses on the mechanical design and materials of an orthodontic bracket, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The document describes a bracket used for orthodontic movement of teeth, which is a structural component of an orthodontic system rather than a device that directly performs a therapeutic function itself.
No
The device description indicates that the Orthodontic Ceramic Bracket is used to apply pressure to teeth to alter their position (orthodontic movement), which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is a physical "Orthodontic Ceramic Bracket" with a "mechanical lock base," indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the device is an "Orthodontic Ceramic Bracket" that is "bonded to teeth to apply pressure to the tooth...to alter the tooth position." This is a mechanical device used for physical manipulation of teeth.
- Intended Use: The intended use is "for orthodontic movement of natural teeth." This is a therapeutic application, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, the device described is a medical device used for orthodontic treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
The Orthodontic Ceramic Bracket is in commercial distribution and consists of a chemically treated base. The modification to the Orthodontic Ceramic Bracket consists of a mechanical lock base and the brackets: are referred to as the Mystique MB Ceramic Brackets. Mystique MB Ceramic Brackets are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The mechanical lock base includes rhomboid and "torque-in-the-base" features. The bracket is transparent and has indented walls and is available with or without glass coating in the wire slot.
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
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)
Not Found
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
NOV - 7 2008
DENTSPLY Internat World Headquarters Susquehanna Commer 221 West Philadelphic ork, PA 17405-087 800) 877-0020 Fax 17171 849-4343 ww.dentsply.com
510(k) SUMMARY
CONTACT: Helen Lewis DATE PREPARED: October 2, 2008 TRADE OR PROPRIETARY NAME: Mystique MB Ceramic Brackets CLASSIFICATION NAME: Orthodontic Ceramic Brackets 872.5470 PREDICATE DEVICES: Orthodontic Ceramic Brackets K042178
DEVICE DESCRIPTION: The Orthodontic Ceramic Bracket is in commercial distribution and consists of a chemically treated base. The modification to the Orthodontic Ceramic Bracket consists of a mechanical lock base and the brackets: are referred to as the Mystique MB Ceramic Brackets. Mystique MB Ceramic Brackets are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The mechanical lock base includes rhomboid and "torque-in-the-base" features. The bracket is transparent and has indented walls and is available with or without glass coating in the wire slot.
INTENDED USE: Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
(ECHNOLOGICAL CHARACTERISTICS: The Mystique MB Ceramic Brackets represent a minor design modification to K042178. There are no changes in intended use or fundamental scientific technology.
All of the components found in Mystique MB Ceramic Brackets have been used in legally marketed devices and/or were found safe for dental use. Mystique MB Ceramic Brackets are the same composition as the predicate device. Therefore, further biocompatibility testing is not necessary.
We believe that the prior use of the components of Mystique MB Ceramic Brackets in the legally marketed devices, the performance data provided, and previously submitted biocompatibility data support the safety and effectiveness of Mystique MB Ceramic Brackets for the indicated uses.
1
Image /page/1/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 image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
NOV - 7 2008
Re: K082974
Trade/Device Name: Mystique MB Ceramic Brackets Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: October 2, 2008 Received: October 9, 2008
Dear Ms. Lewis:
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.
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.
2
Page 2 - Ms. Lewis
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 your 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 yours.
Sutte Y. Mchail Ows..
DR. CHIL LIN Chiu S. Lin, Ph. D FOR Division 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
510(k) Number (if known):
Device Name: Mystique MB Ceramic Brackets
Indications for Use:
Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
These are the same indications for use previously cleared for K042178.
Prescription Use __ X (Part 21 CFR 801 Subpart D) 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)
MGR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Device
510(k) Number: K082974
Premarket Notification
Mystique MB Ceramic Brackets
DENTSPLY International
000017