(90 days)
Not Found
No
The description focuses on the material properties and mechanical function of the archwire, with no mention of AI or ML.
Yes.
The device is used to aid in the movement of patient teeth during orthodontic treatment, which constitutes a therapeutic purpose.
No
Explanation: The device is an orthodontic archwire used for tooth movement during treatment, not for diagnosing any medical condition.
No
The device description clearly states that ClearArch is a "polymer-based orthodontic archwire," which is a physical hardware component.
Based on the provided information, the ClearArch 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.
- ClearArch's Function: The ClearArch is an orthodontic archwire used within the patient's mouth to physically move teeth. It is a medical device used for treatment, not for testing biological samples.
- Intended Use: The intended use clearly states it's for "aiding in the movement of patient teeth during orthodontic treatment." This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical properties and function of the archwire in the mouth.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the ClearArch is a medical device used for orthodontic treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ClearArch is indicated for use as an orthodontic archwire to aid in the movement of patient teeth during orthodontic treatment. ClearArch is intended for patients seeking esthetic orthodontic treatment; these are primarily patients being treated with ceramic or polycarbonate braces.
Product codes
DYW
Device Description
ClearArch is a polymer-based orthodontic archwire for maxillary and mandibular arches. The wire material 1) is more aesthetic than conventional metal wires, 2) can take different shapes, including round, rectangular and square cross-sections, 3) can be bent like TMA and 4) delivers orthodontic forces similar to nickel titanium archwires. This archwire is intended to be used during the first two phases of orthodontic treatment. Its stiffness and strength are similar to the properties of metal orthodontic archwires in order to aid in efficient tooth movement during orthodontic treatment. Therefore, orthodontists can use an esthetic archwire in lieu of a less esthetic metal version without compromising treatment mechanics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 510(k) submission also includes data from bench testing used to evaluate the performance characteristics of ClearArch compared to the predicate device, BioMers Translucent Orthodontic Wire. The characteristics evaluated include flexural strength, tensile strength, friction, water absorption and elongation of standardized comparative samples.
Based upon the biocompatibility tests and bench testing, the clinical performance of ClearArch is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BioMers Products, LLC, BioMers Translucent Orthodontic Wire
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
K10/676
SYBRON DENTAL SPECIALTIES
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
SEP 1 8 2010
· Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7488 - Facsimile Wendy Garman - Contact Person
Date Summary Prepared: June 2010
Device Name:
- Trade Name ClearArch .
- Common Name Orthodontic Wire ●
- � Classification Name - Orthodontic Appliance and Accessories, per 21 CFR § 872.5410
Devices for Which Substantial Equivalence is Claimed:
BioMers Products, LLC, BioMers Translucent Orthodontic Wire .
Device Description:
ClearArch is a polymer-based orthodontic archwire for maxillary and mandibular arches. The wire material 1) is more aesthetic than conventional metal wires, 2) can take different shapes, including round, rectangular and square cross-sections, 3) can be bent like TMA and 4) delivers orthodontic forces similar to nickel titanium archwires. This archwire is intended to be used during the first two phases of orthodontic treatment. Its stiffness and strength are similar to the properties of metal orthodontic archwires in order to aid in efficient tooth movement during orthodontic treatment. Therefore, orthodontists can use an esthetic archwire in lieu of a less esthetic metal version without compromising treatment mechanics.
Intended Use of the Device:
The ClearArch is indicated for use as an orthodontic archwire to aid in the movement of patient teeth during orthodontic treatment. ClearArch is intended for patients seeking esthetic orthodontic treatment; these are primarily patients being treated with ceramic or polycarbonate braces.
1
Substantial Equivalence:
The ClearArch wire is substantially equivalent to one other legally marketed device in the United States. ClearArch functions in a manner similar to and is intended for the same use as the BioMers Translucent Orthodontic Wire which is currently being marketed by BioMers Products LLC. The ClearArch wire differs from the predicate device only in composition, in that, the ClearArch wire is polymer-based while the BioMers Translucent Orthodontic Wire, also polymer-based (BIS-EMA and TEGDMA), has additional glass fibers. Biocompatibility studies have been completed, which demonstrates that the material used to produce ClearArch is safe for its intended use.
The 510(k) submission also includes data from bench testing used to evaluate the performance characteristics of ClearArch compared to the predicate device, BioMers Translucent Orthodontic Wire. The characteristics evaluated include flexural strength, tensile strength, friction, water absorption and elongation of standardized comparative samples.
Based upon the biocompatibility tests and bench testing, the clinical performance of ClearArch is substantially equivalent 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 consists of two main elements: the department's name encircling the symbol. The symbol is a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The text reads "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
Ms. Wendy Garman Director. Regulatory Affairs Sybron Dental Specialties. Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K101676
Trade/Device Name: ClearArch Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Codes: DYW Dated: June 14, 2010 Received: June 15, 2010
SEP 1 3 2010
Dear Ms. Garman:
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.
3
Page 2 - Ms. Garman
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan
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
4
Indications for Use
510(k) Number (if known):
Device Name: ClearArch
SEP 1 3 2010
Indications For Use:
i
The ClearArch is indicated for use as an orthodontic archwire to aid in the movement of patient teeth during orthodontic treatment. ClearArch is intended for patients seeking esthetic orthodontic treatment; these are primarily patients being treated with ceramic or polycarbonate braces.
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 (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital Infection Control, Dental Devices |
| 1 510(k) Number: | K101676 |
|---|---|
| ------------------ | --------- |