Angel Align System

K171674 · Smile Development Corp · NXC · Jan 19, 2018 · Dental

Device Facts

• Record ID: K171674
• Device Name: Angel Align System
• Applicant: Smile Development Corp
• Product Code: NXC · Dental
• Decision Date: Jan 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K171674 · Jan 19, 2018	Angel Align System	Smile Development Corp	Post-market clinical data	The sponsor submitted post-market clinical data to support the safety and effectiveness of the Angel Align System as a sequential aligner.	post-market clinical data; safety and effectiveness

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Post-Market Study; Post-market clinical study	—	Not applicable for this study	Safety and effectiveness for all tooth movements

Indications for Use

Angel Align System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

Device Story

Angel Align System consists of clear, removable plastic orthodontic aligners and proprietary 3D software. Input data includes PVS impression scans or intraoral digital scans of patient teeth. Software generates a 3D model of the current state, simulates a provisional treated state, and interpolates intermediate tooth positions. Dental practitioners review, edit, and approve the treatment plan via the software. Approved plans are sent to rapid prototyping machines to create physical models; aligners are fabricated via thermoforming. Aligners are dispensed to patients to be worn sequentially, typically replaced every two weeks, to move teeth incrementally. Used in dental clinics by practitioners to treat malocclusion as an alternative to fixed wire/bracket appliances.

Clinical Evidence

Post-market clinical data was submitted and passed. The data provides evidence of safety and effectiveness for all tooth movements and demonstrates substantial equivalence to the predicate device.

Technological Characteristics

Removable orthodontic aligners made of 0.03" thick thermoformed polyurethane. System includes 3D software for treatment planning, rapid prototyping machines for physical model fabrication, and thermoforming equipment. Biocompatibility verified per ISO 10993. Software-driven, prescription-based workflow.

Indications for Use

Indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients requiring orthodontic correction.

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

• Invisalign - Align Technology, Inc. (K143630)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Smile Development Corp Ian Kitching President & CEO 7179 Cherrywood Ct Highland, California 92346 January 19, 2018

Re: K171674

Trade/Device Name: Angel Align System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: December 6, 2017 Received: December 11, 2017

Dear Ian Kitching:

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

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801); medical device 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mary S. Runner -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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## 5. Indications for Use Statement (FDA Form 3881)

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|

**Indications for Use**

| 510(k) Number (if known) | K171674 |
|--------------------------------|----------------------------------------------------------------------------------------------------------|
| Device Name | Angel Align |
| Indications for Use (Describe) | Angel Align System is indicated for the alignment of teeth during orthodontic treatment of malocclusion. |

Type of Use (Select one or both, as applicable)

| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|

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| 6. 510(k) Summary | |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) SUMMARY | |
| 510(k) Owner | Smile Development Corp.<br>7179 Cherrywood Court<br>Highland, CA 92346<br>Phone: [phone] |
| Contact person | Ian Kitching<br>Smile Development Corp.<br>7179 Cherrywood Court<br>Highland, CA 92346<br>Phone: [phone]<br>[e-mail] |
| Submission Date | December 11, 2017 |
| Product Code:<br>Common Name | Orthodontic Plastic Brackets |
| Trade Name | Angel Align System |
| Classification Name | aligner, sequential |
| Regulation | 872.5470 |
| Class | Class II |
| Panel | Dental |
| Product Code | NXC |
| Predicate | K143630<br>Invisalign - Align Technology, Inc. |
| Description | |

#### iption

The Angel Align System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state.

The Angel Align System is intended as an alternative to conventional wire/bracket technology and fixed appliances for the treatment of patients with malocclusion.

The 3D software generates the model of a provisional treated state and then creates a series of models that represent intermediate teeth states. The dental practitioner reviews these models to view, edit or approve the orthodontic treatment plan. The dental practitioner has the option to

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reject or request modifications to the set-up prior to approving it for aligner fabrication. Once the doctor approves the set-up, the series of custom-made aligners are manufactured, packaged, and shipped to the dental practitioner to be dispensed to the patient for treatment.

#### Indications for Use

Angel Align System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

#### Technological Characteristics

The predicate and the Angel Align System were compared in the following areas and found to have similar technological characteristics and to be equivalent:

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| | Angel Align System | K143630 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>Statement | SAME<br>The Angel Align System is<br>indicated for the alignment of<br>teeth during orthodontic treatment<br>of malocclusion. | SAME<br>The Invisalign System is indicated<br>for the alignment of teeth during<br>orthodontic treatment of<br>malocclusion. |
| 3-D Software<br>Description | SAME<br>The Angel Align 3-D Software uses<br>a scan of a PVS impression or a<br>digital scan (which represents an<br>untreated state) to generate the<br>image of a final, provisional<br>treated state and then interprets a<br>series of images that represent<br>intermediate teeth states. The<br>dental practitioner then reviews<br>these images and has the option to<br>reject or request modifications to<br>the set-up prior to approving it for<br>aligner fabrication. Once the<br>dental practitioner approves the<br>treatment plan, the software<br>converts the files to produce the<br>series of custom-made aligners | SAME<br>The Align 3-D Software uses a scan<br>of a PVS impression or a digital scan<br>(which represents an untreated<br>state) to generate the image of a<br>final, treated state and then<br>interprets a series of images that<br>represent intermediate teeth states.<br>The dental practitioner then reviews<br>these images and has the option to<br>reject or request modifications to the<br>set-up prior to approving it for<br>aligner fabrication. Once the dental<br>practitioner approves the treatment<br>plan, the software converts the files<br>to produce the series of custom-<br>made aligners |
| Mode of<br>Operation for 3-D<br>Software | SAME<br>Angel Align System 3-D software<br>performs the following operations:<br>Produce 3D-model file of<br>the PVS impression or<br>digital scan. Identifies the individual<br>teeth that will require<br>treatment (i.e.<br>repositioning). Creates a treatment plan<br>(i.e. 3-D models that<br>represent the treatment<br>plan). The treating dental<br>practitioner reviews these<br>images using software and<br>has the option to reject or<br>request modifications to<br>the set-up prior to | SAME<br>Invisalign system 3-D software<br>performs the following operations:<br>Produce 3D-model file of the<br>PVS impression or digital<br>scan. Identifies the individual<br>teeth that will require<br>treatment (i.e.<br>repositioning). Creates a treatment plan (i.e.<br>3-D models that represent<br>the treatment plan). The<br>treating dental practitioner<br>reviews these images using<br>ClinCheck software and has<br>the option to reject or<br>request modifications to the<br>set-up prior to approval. |
| Material | | The Invisalign System uses either: |
| | SAME<br>0.03" thick, thermoformed<br>polyurethane | DIFFERENT<br>1. 0.03" thick, Multilayer aromatic<br>thermoplastic polyurethane /<br>copolyester.<br>or:<br>SAME<br>2. 0.03" thick, thermoformed<br>polyurethane |
| Mode of Use | SAME<br>Each appliance is worn by the<br>patient as determined by the<br>dental practitioner, generally 2<br>weeks prior to being replaced by<br>the next aligner in sequence. | SAME<br>Each appliance is worn by the dental<br>practitioner, generally 2 weeks prior<br>to being replaced by the next aligner<br>in sequence. |
| Description of<br>Appliance<br>Application | SAME<br>Removable | SAME<br>Removable |
| Manufacturing<br>Method | SAME<br>A digital model of the patient's<br>teeth is created from either CT<br>scanning a PVS impression or<br>directly from an intraoral scan of<br>the patient's teeth. From the<br>digital model, following a dental<br>practitioner's prescription, the<br>software generates model<br>transforms describing the<br>provisional final, treated state and<br>then interpolates a series of model<br>transforms that represent<br>intermediate states of alignment.<br>The resulting computer "setups"<br>relay this information to rapid<br>prototyping machines that produce<br>physical positive models. The<br>aligners are produced by<br>thermoforming on each physical<br>model to fabricate the sequence of<br>aligners. | SAME<br>A digital model of the patient's teeth<br>is created from either CT scanning a<br>PVS impression or directly from an<br>intraoral scan of the patient's teeth.<br>From the digital model, following a<br>dental practitioner's prescription, the<br>software generates model transforms<br>describing the final, treated state and<br>then interpolates a series of model<br>transforms that represent<br>intermediate states of alignment.<br>The resulting computer “setups”<br>relay this information to rapid<br>prototyping machines that produce<br>physical positive models. The<br>aligners are produced by<br>thermoforming on each physical<br>model to fabricate the sequence of<br>aligners. |

### Device Comparison Table

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The predicate and the Angel Align System were compared in the following area and found to have minor different technological characteristics. The following differences have been determined to not have any impact on the safety or efficacy of the Angel Align System:

| | Angel Align System | K143630 |
|----------|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Material | | The Invisalign System uses either: |
| | | <b>DIFFERENT</b><br>1. 0.03" thick, Multilayer aromatic<br>thermoplastic polyurethane /<br>copolyester. |
| | <b>SAME</b><br>0.03" thick, thermoformed<br>polyurethane | or:<br><b>SAME</b><br>2. 0.03" thick, thermoformed<br>polyurethane |

The following non-clinical performance tests were conducted:

| Software Validation | PASS |
|------------------------------------|------|
| Design Verification and Validation | PASS |
| ISO10993 | PASS |

Conclusions from non-clinical performance data

After performing non-clinical performance studies, the data shows that the Angel Align System is substantially equivalent to the predicate as a sequential aligner.

The following post market clinical data was submitted for clinical performance data:

| Post-Market Study | PASS |
|-------------------|------|
|-------------------|------|

Conclusions from the clinical data

The data provides evidence of safety and effectiveness for all tooth movements and demonstrates that the Angel Align System is substantially equivalent to the predicate as a sequential aligner.