OSW Aligner System

K191990 · Osw Manufacturing, LLC · NXC · Aug 23, 2019 · Dental

Device Facts

• Record ID: K191990
• Device Name: OSW Aligner System
• Applicant: Osw Manufacturing, LLC
• Product Code: NXC · Dental
• Decision Date: Aug 23, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

OSW Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

Device Story

The OSW Aligner System consists of custom-made, thin, clear, removable polyurethane orthodontic appliances and proprietary 3D software. The system is used by dental practitioners to treat malocclusion as an alternative to conventional wire/bracket appliances. Input data consists of PVS impressions or digital intraoral scans of the patient's teeth. The 3D software generates a digital model of the current state, creates a provisional final treated state, and interpolates intermediate tooth positions. The practitioner reviews, edits, and approves the treatment plan via the software. Upon approval, the system generates digital files for rapid prototyping machines to create physical models; aligners are then thermoformed over these models. The final series of aligners is shipped to the practitioner and dispensed to the patient, who wears them sequentially to move teeth in small increments, typically changing every two weeks. The device benefits patients by providing a removable, aesthetic orthodontic treatment option.

Clinical Evidence

No clinical testing was performed. The device relies on the well-established clinical performance of sequential aligners (product code NXC) cleared since 1998 and literature to demonstrate substantial equivalence.

Technological Characteristics

Material: 0.03" thick thermoformed polyurethane. Form factor: Removable clear aligners. Manufacturing: Digital model creation from PVS/intraoral scans, software-based treatment planning, rapid prototyping of physical models, and thermoforming. Software: Proprietary 3D planning software. Biocompatibility: Tested per ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 10993-11 (acute systemic toxicity).

Indications for Use

Indicated for patients requiring orthodontic treatment for the alignment of teeth due to malocclusion.

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

• Angel Align System (K171674)

Submission Summary (Full Text)

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August 23, 2019

OSW Manufacturing, LLC % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K191990

Trade/Device Name: OSW Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: July 24, 2019 Received: July 25, 2019

Dear Mark Job:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191990

Device Name OSW Aligner System

Indications for Use (Describe)

OSW Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary (K191990)

| 510(k) Owner | OSW Manufacturing, LLC<br>35778 Elk Lane,<br>Murrieta, CA 92563<br>Phone: [phone] |
|---------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Ian Kitching<br>OSW Manufacturing, LLC<br>35778 Elk Lane,<br>Murrieta, CA 92563<br>Phone: [phone]<br>[e-mail] |
| Date Prepared | August 23, 2019 |
| Product Code: | |
| Common Name | Orthodontic Plastic Brackets |
| Trade Name | OSW Aligner System |
| Classification Name | aligner, sequential |
| Regulation | 872.5470 |
| Class | Class II |
| Panel | Dental |
| Product Code | NXC |
| Primary Predicate | K171674<br>Angel Align System |

#### Description

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

The OSW Aligner 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 setup prior to approving it for aligner fabrication. Once the doctor approves the setup, 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

OSW Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

#### Technological Characteristics

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

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| Device Comparison Table | | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | OSW Aligner System | K171674 |
| Indications for<br>Use Statement | The OSW Aligner System is indicated<br>for the alignment of teeth during<br>orthodontic treatment of<br>malocclusion. | The Angel Align System is<br>indicated for the alignment of<br>teeth during orthodontic treatment<br>of malocclusion. |
| 3-D Software<br>Description | The OSW Manufacturing 3-D<br>Software uses a scan of a PVS<br>impression or a digital scan (which<br>represents an untreated state) to<br>generate the image of a final,<br>provisional 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 | The Angel 3-D Software uses a<br>scan of a PVS impression or a<br>digital scan (which represents an<br>untreated state) to generate the<br>image of a final, treated state and<br>then interprets a series of images<br>that represent intermediate teeth<br>states. The dental practitioner then<br>reviews these images and has the<br>option to reject or request<br>modifications to the set-up prior to<br>approving it for aligner fabrication.<br>Once the dental practitioner<br>approves the treatment plan, the<br>software converts the files to<br>produce the series of custom-made<br>aligners |
| Mode of<br>Operation for 3-D<br>Software | OSW Aligner 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>OSWDP software and has<br>the option to reject or<br>request modifications to the<br>set-up prior to approval. | 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 iOrtho<br>software and has the<br>option to reject or request<br>modifications to the set-up<br>prior to approval. |
| Material | 0.03" thick, thermoformed<br>polyurethane | 0.03" thick, thermoformed<br>polyurethane |
| Mode of Use | Each appliance is worn by the patient as determined by the dental practitioner, generally 2 weeks prior to being replaced by the next aligner in sequence. | Each appliance is worn by the patient as determined by the dental practitioner, generally 2 weeks prior to being replaced by the next aligner in sequence. |
| Description of Appliance Application | Removable | Removable |
| Manufacturing Method | A digital model of the patient's teeth is created from either scanning a PVS impression or directly from an intraoral scan of the patient's teeth. From the digital model, following a dental practitioner's prescription, the software generates model transforms describing the provisional final, treated state and then interpolates a series of model transforms that represent intermediate states of alignment. The resulting computer "setups" relay this information to rapid prototyping machines that produce physical positive models. The aligners are produced by thermoforming on each physical model to fabricate the sequence of aligners. | A digital model of the patient's teeth is created from either CT scanning a PVS impression or directly from an intraoral scan of the patient's teeth. From the digital model, following a dental practitioner's prescription, the software generates model transforms describing the final, treated state and then interpolates a series of model transforms that represent intermediate states of alignment. The resulting computer "setups" relay this information to rapid prototyping machines that produce physical positive models. The aligners are produced by thermoforming on each physical model to fabricate the sequence of aligners. |

## Device Comparison Table

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### Technological Characteristic Differences

There are no major technological characteristic differences when comparing the subject device and the predicate device, with only differences in location of manufacturing. Non-clinical performance testing mitigated any concerns regarding this difference.

### Non-Clinical Performance Testing

The following non-clinical performance tests were conducted:

| Report Name | Standard | Result |
|--------------------------------------------------------------|--------------------|--------|
| OSW OrthoSetup Software Verification Report | N/A (FDA Guidance) | PASS |
| OSWDP System and Software Verification Report | N/A (FDA Guidance) | PASS |
| Biocompatibility testing of device - Cytotoxicity | ISO 10993-5 | PASS |
| Biocompatibility testing of device - Irritation | ISO 10993-10 | PASS |
| Biocompatibility testing of device - Sensitization | ISO 10993-10 | PASS |
| Biocompatibility testing of device - Acute Systemic Toxicity | ISO 10993-11 | PASS |

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## Clinical Testing

The performance of sequential aligners in the clinical environment has been well established since the first aligners were cleared by the FDA under product code NXC in 1998. Therefore, clinical testing was not necessary to demonstrate substantial equivalence of the OSW Aligner System to the predicate device.

## Bench Testing

Bench testing of the aligners has not been performed due to the difficulty in evaluating this type of dental device in a laboratory setting. There is sufficient information available from the scientific literature and from the predicate device to demonstrate substantial equivalence of the OSW Aligner System to the predicate device.

# Substantial Equivalence Conclusion

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Based on the comparison and analysis above, the OSW Aligner System is determined to be substantially equivalent to the referenced primary predicate device.