(515 days)
Not Found
No
The description focuses on the mechanical properties and design of the orthodontic appliance and wire system. There is no mention of AI or ML being used in the design, manufacturing, or treatment planning process. The customization of the wire is described as being determined and approved by the provider.
Yes
The device is described as an orthodontic appliance that uses a bracket and archwire system to provide orthodontic movement of natural teeth, which is a therapeutic function to correct dental alignment.
No
This device is an orthodontic appliance designed for tooth movement, not for diagnosing medical conditions.
No
The device description clearly outlines physical components: a polysulfone bracket, an orthodontic wire, and a tool for removal. Performance studies also focus on mechanical properties and shear bond strength, indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide orthodontic movement of natural teeth." This is a therapeutic purpose, directly affecting the patient's physical structure (teeth).
- Device Description: The device is a physical appliance (bracket and wire system) used to apply force to teeth for movement. It does not involve testing or analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition or provide information about a patient's health status.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information. The device's function is purely mechanical and therapeutic.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
CompleClear appliances are intended for use as a clear, plastic bracket and archwire system to provide orthodontic movement of natural teeth.
Product codes (comma separated list FDA assigned to the subject device)
DYW, DZC
Device Description
CompleClear Plastic Orthodontic Bracket and Wire Appliance is an orthodontic appliance consisting of a polysulfone bracket with two separate components (tooth component and wire component) and an orthodontic wire pre-attached to the wire component of the bracket. The tooth and the wire components are capable of mechanically interlocking to form a detachable and reattachable bracket assembly. The tooth component of the bracket is cemented to the tooth, like regular orthodontic brackets. The wire components are pre-attached at specific positions along the orthodontic wire. The orthodontic wire is customized for each patient by creating various bends and rotations along the wire. This configuration of the customized wire, results in a specific position and orientation of the wire components of the bracket system along the customized wire. This customized orthodontic wire along with the series of pre-attached wire components constitutes the 'aligner'. When the wire components of the 'aligner' are engaged on to the corresponding tooth component cemented on the tooth, the orthodontic wire is activated like a spring. The tooth is gently moved to its desired position due to the elastic recoil of the wire.
The two component bracket assembly of the present device allows moment arms for mesiodistal rotation, labio-lingual inclination and mesio-distal angulations (tip) similar to conventional bracket-wire used in orthodontics.
The treatment uses a series of aligners, each incorporating a predefined amount to tooth movement toward the final desired end goal. The amount of tooth movement incorporated, the type of tooth movement incorporated and the final desired end goal are all determined and approved by the provider.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
natural teeth
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)
Physical testing: Mechanical testing showed the force which could be applied by deflection of the wire was within the range of other orthodontic forces. The force required to break the melt and remove the wire from the bracket was significantly higher than the force which could be applied by the wire. The force necessary to snap the aligner away from the cemented brackets was also significantly higher than the orthodontic forces applied to the teeth. This ensures integrity of the aligner during function and also that aligner does not detach until the dentist or patient intends to remove it. A tool is normally used to remove the aligner. Since the wire in the aligner acts more like a spring friction testing was not appropriate.
Shear bond strength testing of the brackets adhered to teeth was carried out on both CompleClear and Ortho Specialties' brackets. There was no statistical difference in them.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2016
OraCrew Inc. c/o Ms. Angela Blackwell Senior Consultant Blackwell Device Consulting 210 E Flamingo Rd #217 Las Vegas, Nevada 89169
Re: K150830
Trade/Device Name: CompleClear Plastic Orthodontic Bracket and Wire Appliance Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: DYW, DZC Dated: August 24, 2016 Received: August 26, 2016
Dear Ms. Blackwell:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name
CompleClear Plastic Orthodontic Bracket and Wire Appliance
Indications for Use (Describe)
CompleClear appliances are intended for use as a clear, plastic bracket and archwire system to provide orthodontic movement of natural teeth.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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510k Summary March 2, 2016 CompleClear Plastic Orthodontic Bracket and Wire Appliance
Name and address:
Oracrew Inc 210 E Flamingo Rd #314 Las Vegas, NV 89169 (760) 237-0163
Contact person:
Dr. Pawan Gautam 210 E Flamingo Rd #314 Las Vegas, NV 89169 (760) 237-0163
Name of device: CompleClear Plastic Orthodontic Bracket and Wire Appliance Classification Name: orthodontic plastic bracket and wire CFR: 21 CFR 872.5470 and 872.5410 Product Code: DYW and DZC Classification: II and I
Device Description: CompleClear Plastic Orthodontic Bracket and Wire Appliance is an orthodontic appliance consisting of a polysulfone bracket with two separate components (tooth component and wire component) and an orthodontic wire pre-attached to the wire component of the bracket. The tooth and the wire components are capable of mechanically interlocking to form a detachable and reattachable bracket assembly. The tooth component of the bracket is cemented to the tooth, like regular orthodontic brackets. The wire components are pre-attached at specific positions along the orthodontic wire. The orthodontic wire is customized for each patient by creating various bends and rotations along the wire. This configuration of the customized wire, results in a specific position and orientation of the wire components of the bracket system along the customized wire. This customized orthodontic wire along with the series of pre-attached wire components constitutes the 'aligner'. When the wire components of the 'aligner' are engaged on to the corresponding tooth component cemented on the tooth, the orthodontic wire is activated like a spring. The tooth is gently moved to its desired position due to the elastic recoil of the wire.
The two component bracket assembly of the present device allows moment arms for mesiodistal rotation, labio-lingual inclination and mesio-distal angulations (tip) similar to conventional bracket-wire used in orthodontics.
5
The treatment uses a series of aligners, each incorporating a predefined amount to tooth movement toward the final desired end goal. The amount of tooth movement incorporated, the type of tooth movement incorporated and the final desired end goal are all determined and approved by the provider.
Indications for Use: CompleClear appliances are intended for use as a clear, plastic bracket and archwire system to provide orthodontic movement of natural teeth.
Predicate Device: K110796 Biomers SimpliClear Rectangular Orthodontic Wire and K140807 Ortho Specialties Incorporated Composite Brackets
Substantial Equivalence:
CompleClear is substantially equivalent to Ortho Specialties Composite Brackets and Biomers Rectangular Orthodontic Wire in indications for use, materials, aesthetic features, mode of use, physical properties, application and manufacturing methods.
| Company | CompleClear | Composite Brackets
K140807 | SimpliClear
Rectangular
Orthodontic Wire
K110796 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | CompleClear Appliances
are intended for use a
clear plastic bracket and
archwire system to
provide orthodontic
movement of natural
teeth. | The Composite Brackets
are intended for use as a
clear, plastic bracket
system to provide
orthodontic movement of
natural teeth. | An orthodontic
archwire used to
provide force to the
teeth to effect
movement in
orthodontic
treatment. |
| Material | Bracket is polysulfone
Archwire is glass fibers
with a polysulfone
coating | Polycarbonate | Polymer composite
resin with glass
fibers and a USP
Class VI polymer
coating |
| Aesthetic Features | Clear (translucent)
bracket system
Clear wire | Clear (translucent)
bracket system | Clear wire |
| Mode of Use | Patient-specific Aligner
(Archwire pre-attached
to outer half of brackets)
made to fit stone model
under dental
professionals orders | Archwire implementation
by dental professionals
technique | Archwire
implementation by
dental
professionals
technique |
| Application | Tooth half of bracket
bonded to teeth and
aligner snapped into
place | Bracket bonded to tooth | Wire placed with
ligatures |
| Bracket Manufacturing
Method | Molded, thermoformed | Molded, thermoformed | |
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| Wire manufacturing
method | Composite of polymer
and glass fibers with a
polymer coating on the
outside | Composite of
polymer and glass
fibers with a
polymer coating on
the outside |
|------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Biocompatibility | Meets the requirements
of ISO 10993-3:2014, ISO
10993-5:2009, ISO
10993-10:2010 and ISO
10993-11:2006 | Meets the requirements
of ISO 10993 |
Physical testing: Mechanical testing showed the force which could be applied by deflection of the wire was within the range of other orthodontic forces. The force required to break the melt and remove the wire from the bracket was significantly higher than the force which could be applied by the wire. The force necessary to snap the aligner away from the cemented brackets was also significantly higher than the orthodontic forces applied to the teeth. This ensures integrity of the aligner during function and also that aligner does not detach until the dentist or patient intends to remove it. A tool is normally used to remove the aligner. Since the wire in the aligner acts more like a spring friction testing was not appropriate.
Shear bond strength testing of the brackets adhered to teeth was carried out on both CompleClear and Ortho Specialties' brackets. There was no statistical difference in them.
Conclusion: The CompleClear Plastic Orthodontic Bracket and Wire Appliance is substantially equivalent to the Composite Brackets (K140807) and the SimpliClear rectangular orthodontic wire (K110796) in manufacturing, materials, biocompatibility, applications for use and shear bond strength.