CompleClear Plastic Orthodontic Bracket and Wire Appliance

K150830 · Oracrew · DYW · Aug 26, 2016 · Dental

Device Facts

• Record ID: K150830
• Device Name: CompleClear Plastic Orthodontic Bracket and Wire Appliance
• Applicant: Oracrew
• Product Code: DYW · Dental
• Decision Date: Aug 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

CompleClear appliances are intended for use as a clear, plastic bracket and archwire system to provide orthodontic movement of natural teeth.

Device Story

CompleClear is a clear, plastic orthodontic bracket and archwire system. It consists of a two-component polysulfone bracket: a tooth component cemented to the tooth and a wire component pre-attached to a customized orthodontic wire. The wire components are positioned along the wire to create an 'aligner' assembly. When the wire components snap into the tooth components, the wire acts as a spring, applying force to move teeth. The system is used by dental professionals to treat patients. Treatment involves a series of aligners, each designed for a specific amount of tooth movement toward a final goal determined by the provider. The device allows for mesiodistal rotation, labio-lingual inclination, and mesio-distal angulations. The aligner remains secure during function but can be removed by the dentist or patient using a tool.

Clinical Evidence

Bench testing only. Mechanical testing evaluated force application via wire deflection, confirming forces are within the range of other orthodontic systems. Testing confirmed the force required to remove the wire or snap the aligner from the brackets is significantly higher than the orthodontic forces applied to the teeth. Shear bond strength testing of brackets adhered to teeth showed no statistical difference compared to the predicate device. Biocompatibility testing met requirements of ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2006.

Technological Characteristics

Bracket material: polysulfone. Archwire material: glass fibers with polysulfone coating. System consists of a two-component interlocking bracket assembly (tooth component and wire component). Manufacturing: molded and thermoformed. Biocompatibility: ISO 10993 compliant. Connectivity: none (mechanical system).

Indications for Use

Indicated for orthodontic movement of natural teeth in patients requiring orthodontic treatment.

Regulatory Classification

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.

Predicate Devices

• Biomers SimpliClear Rectangular Orthodontic Wire (K110796)
• Ortho Specialties Incorporated Composite Brackets (K140807)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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 [phone]

#### Contact person:

Dr. Pawan Gautam 210 E Flamingo Rd #314 Las Vegas, NV 89169 [phone]

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.

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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<br>K140807 | SimpliClear<br>Rectangular<br>Orthodontic Wire<br>K110796 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | CompleClear Appliances<br>are intended for use a<br>clear plastic bracket and<br>archwire system to<br>provide orthodontic<br>movement of natural<br>teeth. | The Composite Brackets<br>are intended for use as a<br>clear, plastic bracket<br>system to provide<br>orthodontic movement of<br>natural teeth. | An orthodontic<br>archwire used to<br>provide force to the<br>teeth to effect<br>movement in<br>orthodontic<br>treatment. |
| Material | Bracket is polysulfone<br>Archwire is glass fibers<br>with a polysulfone<br>coating | Polycarbonate | Polymer composite<br>resin with glass<br>fibers and a USP<br>Class VI polymer<br>coating |
| Aesthetic Features | Clear (translucent)<br>bracket system<br>Clear wire | Clear (translucent)<br>bracket system | Clear wire |
| Mode of Use | Patient-specific Aligner<br>(Archwire pre-attached<br>to outer half of brackets)<br>made to fit stone model<br>under dental<br>professionals orders | Archwire implementation<br>by dental professionals<br>technique | Archwire<br>implementation by<br>dental<br>professionals<br>technique |
| Application | Tooth half of bracket<br>bonded to teeth and<br>aligner snapped into<br>place | Bracket bonded to tooth | Wire placed with<br>ligatures |
| Bracket Manufacturing<br>Method | Molded, thermoformed | Molded, thermoformed | |

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| Wire manufacturing<br>method | Composite of polymer<br>and glass fibers with a<br>polymer coating on the<br>outside | Composite of<br>polymer and glass<br>fibers with a<br>polymer coating on<br>the outside |
|------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Biocompatibility | Meets the requirements<br>of ISO 10993-3:2014, ISO<br>10993-5:2009, ISO<br>10993-10:2010 and ISO<br>10993-11:2006 | Meets the requirements<br>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.