(65 days)
CuTiNi Wire
Not Found
No
The summary describes a metallic shape memory alloy archwire and its physical properties, with no mention of AI or ML.
No.
Explanation: The device is an orthodontic archwire used for tooth movement, which is a structural and mechanical correction, not a therapeutic treatment for disease or illness.
No
The device is described as an orthodontic archwire used to aid in the movement of teeth, which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a "metallic shape memory alloy orthodontic archwire," indicating it is a physical 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 to "aid in the movement of teeth during the early phase of orthodontic treatment." This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a physical archwire used to apply force to teeth. It does not involve analyzing biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing information for diagnosis, monitoring, or screening.
- Using reagents or assays.
The device is a medical device used for treatment, specifically in orthodontics.
N/A
Intended Use / Indications for Use
The Hyperelastic Archwire is indicated for use as an orthodontic arch wire to aid in the movement of teeth during the early phase of orthodontic treatment. The Hyperelastic Archwire may be used in conjunction with metallic, ceramic, or plastic brackets.
Product codes
DZC
Device Description
Hyperelastic Archwire is a metallic shape memory alloy orthodontic archwire for maxillary and mandibular arches. This alloy exerts low constant forces, retains elastic properties at large strains, with low frictional binding properties.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and mandibular arches (teeth)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental practitioner
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)
Biocompatibility studies have been completed, which demonstrate that the material used to produce Hyperelastic Archwire is safe for its intended use.
The 510(k) submission also includes data from bench testing used to evaluate the performance characteristics of Hyperelastic Archwire compared to the predicate device, CuTiNi Archwire. The characteristics evaluated include tensile plateau, tensile hysteresis, flexure hysteresis, binding, hardness, roughness, set angle after 90° bend, elastic recovery and fatigue.
Clinical testing has not been conducted on this product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CuTiNi Wire
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.5410 Orthodontic appliance and accessories.
(a)
Identification. An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
NOV 1 6 2011
510(k) Summary
Submitter:
Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7488 - Facsimile Wendy Garman - Contact Person
Date Summary Prepared: September 2011
- Trade name HYPERELASTIC ARCHWIRE .
- . Common name - orthodontic appliance & accessories
- ◆ Classification name -- orthodontic wire (21 CFR 872.5410, Product Code DZC)
Devices for Which Substantial Equivalence is Claimed:
CuTiNi Wire, Class I, Exempt, Product Code DZC, Ormco Corporation .
Summary
Device Description
Hyperelastic Archwire is a metallic shape memory alloy orthodontic archwire for maxillary and mandibular arches. This alloy exerts low constant forces, retains elastic properties at large strains, with low frictional binding properties.
Intended use of the Device
The Hyperelastic Archwire is indicated for use as an orthodontic arch wire to aid in the movement of teeth during the early phase of orthodontic treatment. The Hyperelastic Archwire may be used in conjunction with metallic, ceramic, or plastic brackets.
1
Technological Characteristics Compared to Predicate
Hyperelastic Archwire functions in a manner similar to and is intended for the same use as CuTiNi Archwire which is currently being marketed by Ormco Corporation. Both products are made of similar materials, must be placed and removed by the dental practitioner, and both have equivalent corrosion resistance.
Hyperelastic Archwire differs from the predicate device, CuTiNi Archwire in that the physical and mechanical property testing of Hyperelastic Archwire demonstrates greater superelastic strain recovery, a significant reduction in orthodontic binding friction, significantly less stress hysteresis in tensile loading, and greater fatigue life.
Non-Clinical Performance Data
Biocompatibility studies have been completed, which demonstrate that the material used to produce Hyperelastic Archwire is safe for its intended use.
The 510(k) submission also includes data from bench testing used to evaluate the performance characteristics of Hyperelastic Archwire compared to the predicate device, CuTiNi Archwire. The characteristics evaluated include tensile plateau, tensile hysteresis, flexure hysteresis, binding, hardness, roughness, set angle after 90° bend, elastic recovery and fatigue.
Clinical Testing
Clinical resting has not been conducted on this product.
Conclusion
Based upon the biocompatibility tests and bench testing, the clinical performance of Hyperelastic Archwire is substantially equivalent to the predicate device.
2
Image /page/2/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 is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Ormco Corporation % Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties. Incorporated 1717 West Collins Avenue Orange, California 92867
NOV 16 2011
Re: K112640
Trade/Device Name: Hyperelastic Archwire Regulation Number: 21 CFR 872.5410 Regulation Name: Orthodontic Appliance and Accessories Regulatory Class: I Product Code: DZC Dated: September 8. 2011 Received: September 12, 2011
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.
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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 (OS) 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/ucm 1 15809.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,
Wh 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
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Indications for Use
1/11/2640
510(k) Number (if known):
Device Name: Hyperelastic Archwire
Indications For Use:
The Hyperelastic Archwire is indicated for use as an orthodontic arch wire to aid in the movement of teeth during the early phase of orthodontic treatment. The Hyperelostic Archwire may be used in conjunction with metallic, ceramic, or plastic brackets.
X Prescription Use (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)
| -- | -------------------------------------------- |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K112440 |
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