(142 days)
Not Found
No
The description focuses on the material properties and mechanical performance of orthodontic brackets, with no mention of AI or ML capabilities.
Yes
The device is described as "intended for use in orthodontic treatment" and "used to move the teeth to new positions," which directly indicates a therapeutic purpose.
No
The device is an orthodontic bracket used to apply pressure to teeth for movement, not to diagnose a condition.
No
The device description clearly states it is a physical bracket made of alumina and glass-grit, intended to be affixed to teeth. It 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 treatment" by being "affixed to teeth so that pressure can be exerted on the teeth." This describes a physical intervention on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details the physical components of the bracket and how it's used to move teeth. It doesn't mention any reagents, assays, or procedures for analyzing biological samples.
- Lack of IVD Characteristics: The document 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
The device is clearly a medical device used for a therapeutic purpose (orthodontic treatment) by physically interacting with the patient's teeth.
N/A
Intended Use / Indications for Use
Clarity™ Advanced Ceramic Brackets are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
Clarity Advanced Ceramic Brackets are intended to teeth, upon which an orthodontic wire is used to move the teeth to new positions. Clarity Advanced Ceramic Brackets consist of a translucent alumina body and a glass-grit bonding base. The bracket is either uncoated or coated with a thin film of stabilized zirconia. The brackets incorporate a watersoluble color placement indicator system that marks archwire and vertical slots to aid in bracket positioning and color codes tie wing(s) to facilitate bracket identification.
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)
The nonclinical performance testing analysis shows that Clarity Advanced Ceramic Brackets perform comparably to the predicate devices as follows:
-
- The shear-peel bond strength test measures the force required to debond a bracket when a force is applied in the occlusal direction. The test results showed that the bond strengths of Clarity Advanced, Clarity SL and Clarity brackets are comparable and exceed the minimum bond strength to hold the bracket to the tooth.
-
- The bracket strength test measures the torsional force to break a bracket when a rectangular archwire is twisted in the wire slot. The test results showed that the bracket strengths of Clarity Advanced Ceramic Brackets are comparable to Clarity Metal-Reinforced Ceramic Brackets and InVu Aesthetic Braces and exceed the minimum requirements.
-
- The bracket material friction test measures the surface frictional forces of a stainless steel wire against a bracket surface. The test results showed that the zirconia-coated aluminum i oxide surface exhibited lower coefficients of friction as compared to the uncoated aluminum oxide surface.
-
- The squeeze debond test measures the forces applied to the sections left and right of the vertical slot in the Clarity Advanced, Clarity and Clarity SL brackets which cause the bracket to debond from the adhesive. The test results showed that squeeze debond moments for Clarity Advanced Ceramic Brackets are comparable to those for Clarity™ SL brackets and slightly lower for Clarity brackets.
In addition, a biocompatibility assessment was developed for Clarity Advanced Ceramic Brackets using standard risk assessment techniques and consideration of FDA and internationally recognized guidelines.
- The squeeze debond test measures the forces applied to the sections left and right of the vertical slot in the Clarity Advanced, Clarity and Clarity SL brackets which cause the bracket to debond from the adhesive. The test results showed that squeeze debond moments for Clarity Advanced Ceramic Brackets are comparable to those for Clarity™ SL brackets and slightly lower for Clarity brackets.
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.
K062345, K944286, K950992, K082974
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
FEB 17 2011
| 510(k) Submitter | 3M Unitek Corp, 2724 S Peck Rd, Monrovia, CA 91016 |
|---|---|
| Contact person | L. Marlyn Scheff, Regulatory Affairs |
| Phone: (626) 574-4496 | |
| Date Summary was Prepared | January 12, 2011 |
| Device Name | Clarity™ Advanced Ceramic Brackets |
| Common Name | Orthodontic ceramic bracket |
| Recommended Classification | Orthodontic ceramic bracket |
| (21 CFR 872.5470, Product Code: NJM) |
Predicate Devices
K062345, Clarity™ SL Self-Ligating Ceramic Brackets K944286, Clarity™ Metal-Reinforced Ceramic Brackets K950992, InVu® Aesthetic Braces K082974, Mystique® MB Clear Braces
Description of Device
Clarity Advanced Ceramic Brackets are intended to teeth, upon which an orthodontic wire is used to move the teeth to new positions. Clarity Advanced Ceramic Brackets consist of a translucent alumina body and a glass-grit bonding base. The bracket is either uncoated or coated with a thin film of stabilized zirconia. The brackets incorporate a watersoluble color placement indicator system that marks archwire and vertical slots to aid in bracket positioning and color codes tie wing(s) to facilitate bracket identification.
Indications for Use
Clarity™ Advanced Ceramic Brackets are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
Substantial Equivalence
Both the non-clinical data and the biocompatibility evaluation indicate that Clarity™ Advanced Ceramic Brackets are safe and effective for their intended use in orthodontic treatment and perform as well or better than predicate devices. The table on the next page compares the new device with the predicate devices. Information provided in this 510(k) submission shows that Clarity™ Advanced Ceramic Brackets are substantially equivalent to the predicate devices in terms of intended use, indications for use, composition, device design, and performance. This 510(k) also includes data from bench testing to evaluate the performance of Clarity™ Advanced Ceramic Brackets compared to the predicate devices. The properties evaluated include bond strength, bracket strength, material friction, and debond strength.
1
Technological Characteristics
Clarity Advanced Ceramic Brackets are substantially equivalent in design features to the predicate devices.
Device Material
Clarity Advanced, Clarity SL, Clarity, InVu and Mystique MB brackets all are have a bracket body made of ceramic, with Clarity Advanced, Clarity SL, and InVu brackets made of microfine ceramic. Clarity Advanced, Clarity SL, and Clarity have a glass-grit bonding base whereas In Vu has a molded polymer bonding base and Mystique MB have a molded alumina bonding base. Clarity Advanced has a zirconia, or no coating, on the bracket and in the archwire slot, Clarity SL has a metal liner, or no liner, in the archwire slot, Clarity has a metal liner in the archwire slot. InVu has no liner or coating in the archwire slot, and Mystique MB has a silica coating in the archwire slot. Clarity Advanced has color slot & dot indicators whereas Clarity SL. Clarity, InVu have color dot indicators and Mystique MB has no color indicators.
Device Design
Clarity Advanced, Clarity SL, Clarity, InVu and Mystique MB brackets all have tiewing undercut spaces for orthodontic ligatures. Clarity Advanced, Clarity SL, Clarity and InVu brackets have true-twin tiewings, i.e. four tiewings, for versatile use with auxiliaries. Clarity Advanced. Clarity, and In Vu brackets contain base flanges for bracket placement and adhesive flash cleanup. Clarity Advanced, Clarity SL and InVu brackets contain a molded ceramic bracket body with rounded corners and edges, which replaces the angular profile of machined ceramic brackets, and round hook on the distal-gingival tiewings. Clarity Advanced, Clarity SL and Clarity brackets contain vertical slot and stress concentrator to facilitate debonding of the bracket from the tooth.
Nonclinical Performance Testing
The nonclinical performance testing analysis shows that Clarity Advanced Ceramic Brackets perform comparably to the predicate devices as follows:
-
- The shear-peel bond strength test measures the force required to debond a bracket when a force is applied in the occlusal direction. The test results showed that the bond strengths of Clarity Advanced, Clarity SL and Clarity brackets are comparable and exceed the minimum bond strength to hold the bracket to the tooth.
-
- The bracket strength test measures the torsional force to break a bracket when a rectangular archwire is twisted in the wire slot. The test results showed that the bracket strengths of Clarity Advanced Ceramic Brackets are comparable to Clarity Metal-Reinforced Ceramic Brackets and InVu Aesthetic Braces and exceed the minimum requirements.
-
- The bracket material friction test measures the surface frictional forces of a stainless steel wire against a bracket surface. The test results showed that the zirconia-coated aluminum i oxide surface exhibited lower coefficients of friction as compared to the uncoated aluminum oxide surface.
2
-
- The squeeze debond test measures the forces applied to the sections left and right of the vertical slot in the Clarity Advanced, Clarity and Clarity SL brackets which cause the bracket to debond from the adhesive. The test results showed that squeeze debond moments for Clarity Advanced Ceramic Brackets are comparable to those for Clarity™ SL brackets and slightly lower for Clarity brackets.
In addition, a biocompatibility assessment was developed for Clarity Advanced Ceramic Brackets using standard risk assessment techniques and consideration of FDA and internationally recognized guidelines.
- The squeeze debond test measures the forces applied to the sections left and right of the vertical slot in the Clarity Advanced, Clarity and Clarity SL brackets which cause the bracket to debond from the adhesive. The test results showed that squeeze debond moments for Clarity Advanced Ceramic Brackets are comparable to those for Clarity™ SL brackets and slightly lower for Clarity brackets.
Clinical Performance Testing
No clinical performance testing was conducted on Clarity™ Advanced Ceramic Brackets.
Conclusion
The results from the nonclinical performance testing and the biocompatibility assessment demonstrate that Clarity Advanced Ceramic Brackets are safe and effective for their intended use and perform as well as predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three wavy lines emanating from a central point. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Ms. Marlyn L. Scheff Regulatory Affairs 3M UNITEK Corporation 2724 South Peck Road Monrovia, California 91016
FEB 17 2011
Re: K102803
Trade/Device Name: Clarity" Advanced Ceramic Brackets Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: January 26, 2011 Received: February 1, 2011
Dear Ms. Scheff:
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.
4
Page 2- Ms. Scheff
Enclosure
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.fdaggov/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Anstmen Un
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
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Indications for Use
510(k) Number (if known): K102803
Device Name: ClarityTM Advanced Ceramic Brackets
Indications for Use:
Clarity™ Advanced Ceramic Brackets are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
Prescription Use X (Per 21 CFR 801 Subpart D) 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
Susan Runse
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: CD 2803