SmileGuard

K220894 · Envisiontec GmbH · MQC · Jun 10, 2022 · DE

Device Facts

• Record ID: K220894
• Device Name: SmileGuard
• Applicant: Envisiontec GmbH
• Product Code: MQC · DE
• Decision Date: Jun 10, 2022
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

SmileGuard™ light curable resin is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards and splints.

Device Story

SmileGuard is a light-curable resin used in additive manufacturing of dental appliances; specifically mouthguards, nightguards, and splints. The system integrates the resin with a scanner, design software, a validated 3D printer, and a curing unit. The resin is supplied in lightproof bottles with an RFID tag that identifies material, name, and amount for use with specific EnvisionTEC 3D printers. Dental laboratories and practices use the system to create customized appliances. The process involves scanning, digital design, 3D printing, and light curing. The output is a biocompatible, customized dental appliance. The device benefits patients by providing an alternative to heat-curing and auto-polymerizing resins for custom-fit oral appliances.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing performed per ISO 10993 (cytotoxicity, sensitization, irritation). Mechanical property testing performed per ISO 527 (tensile strength/modulus, elongation) and ASTM D790/D256/D2240 (flexural strength/modulus, IZOD impact, Shore D hardness). Shelf life validated for 18 months.

Technological Characteristics

Light-curable resin composed of acrylate/methacrylate, methacrylated oligomers/monomers, photoinitiators, colorants, and absorbers. Non-sterile. Additive manufacturing process. Validated for use with specific EnvisionTEC 3D printers (Perfactory series). RFID tag integration for material identification. Complies with ISO 20795-2, ISO 527-1, ISO 10993, ASTM D790, ASTM D256, and ASTM D2240.

Indications for Use

Indicated for the fabrication of orthodontic and dental appliances including mouthguards, nightguards, and splints for patients requiring such devices.

Predicate Devices

• KeyPrint® KeySplint Soft™ (K183598)

Submission Summary (Full Text)

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June 10, 2022

EnvisionTEC GmbH Patsy Trisler Regulatory Consultant Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250

Re: K220894

Trade/Device Name: SmileGuard Regulatory Class: Unclassified Product Code: MQC, KMY Dated: March 22, 2022 Received: March 28, 2022

Dear Patsy Trisler:

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.

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

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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.

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K220894

Device Name

SmileGuard™

Indications for Use (Describe)

SmileGuard™ light curable resin is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards and splints.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------|--|
| <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |
| <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |

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## 510(k) Summary

| I. SUBMITTER | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Submitter Name: | EnvisionTEC GmbH | |
| Submitter Address: | Brusseler Straße 51<br>D-45968 Gladbeck<br>Germany | |
| Contact Person:<br>Email: | Ruediger van Bernum, Head of Application<br>[e-mail] | |
| Telephone: | [phone] | |
| Date Prepared: | 22 March 2022 | |
| II. DEVICE | | |
| Trade Name: | SmileGuard™ | |
| Common Name | Mouthguard, Prescription | |
| Regulatory Name<br>Classification<br>Product Codes | Mouthguard, Prescription<br>Unclassified<br>MQC | Positioner, Tooth, Preformed<br>21 CFR 872.5525, Class 1<br>KMY |
| III. PREDICATE DEVICE | | |
| Primary Predicate<br>Device: | K183598, KeyPrint® KeySplint Soft™, Keystone Industries | |
| IV. INDICATIONS FOR USE STATEMENT<br>SmileGuard™ light curable resin is indicated for the fabrication of orthodontic and dental<br>appliances such as mouthguards, nightguards and splints. | | |
| V. DEVICE DESCRIPTION | | |
| Device<br>ldentification<br>and | The SmileGuard™ system combines the light-curable resin, for use<br>with a scanner with design software, validated 3D printer and a<br>curing unit. These components are used together during the<br>additive manufacture of dental appliance splints/mouth guards. | |
| Technological<br>Characteristics | The light-curing resin is a proprietary composition of acrylate/<br>methacrylate, methacrylated oligomers and monomers, photo<br>initiators, colorants/dyes and absorbers. It is used by dental<br>laboratories and dental practices to make customized bite splints,<br>using the 3D-printer. | |
| | The resin is filled in lightproof 1 kg PE bottles labeled and offered<br>together with a programmed RFID chip (referred to as TAG), which<br>is required for use with the validated EnvisionTEC 3D printers. The<br>TAG contains information identifying the resin: material, name and<br>amount. | |

.

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Г

| The SmileGuard™ resin is an alternative material to heat-curing and auto-polymerizing resins. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EnvisionTEC's 3D printer models designed for use with the SmileGuard™ light-curing resin are: |
| <b>Printers with bulb</b><br>Perfactory® DDP4<br><b>Printers with LED</b><br>Perfactory® Vida 2<br>Perfactory® Vida 2 Hi-RES<br>Perfactory® Vida HD cDLM<br>Perfactory® Vida cDLM<br>Perfactory® P4K 35,62,75,90<br>Perfactory® MicroPlusXL<br>Perfactory® EnvisionOne cDLM<br>Perfactory® D4K |

| VI. SUBSTANTIAL EQUIVALENCE COMPARISON TABLE | | | |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NEW DEVICE | PRIMARY PREDICATE | |
| 510(k) NUMBER;<br>DEVICE NAME;<br>MANUFACTURER | Not yet assigned<br>SmileGuard ™<br>EnvisionTEC GmbH | K183598<br>KeyPrint® KeySplint Soft™<br>Keystone Industries | |
| PRODUCT CODE<br>REGULATORY NAME<br>CLASSIFICATION<br>(21 CFR) | MQC KMY<br>Mouthguard, Positioner,Tooth,<br>Prescription Preformed<br>Unclassified 872.5525,<br>Class 1 | MQC KMY<br>Mouthguard, Positioner,Tooth,<br>Prescription Preformed<br>Unclassified 872.5525,<br>Class 1 | |
| INDICATIONS FOR<br>USE | SmileGuard™ light curable resin<br>is indicated for the fabrication of<br>orthodontic and dental<br>appliances such as<br>mouthguards, nightguards and<br>splints. | | The KeyPrint® KeySplint Soft™<br>device is indicated for the<br>fabrication of orthodontic and<br>dental appliances such as<br>mouthguards, nightguards,<br>splints and repositioners. |
| INGREDIENTS | Light-curing Resin | Light-curing Resin | |
| MANUFACTURING<br>TECHNOLOGY TYPE | Additive | Additive | |
| Sterility | Non-sterile | Non-sterile | |
| Biocompatibility | Biocompatible, according to ISO<br>10993 testing | Biocompatible, according to ISO<br>10993 testing | |
| PRODUCT<br>CHARACTERISTICS: | Sample conditioned for 24 hr after<br>printing: | | |
| Tensile Strength | $19.1 +/- 2.5$ MPa [per ISO 527] | Unknown | |
| Tensile Modulus | $319 +/- 48$ MPA [per ISO 527] | Unknown | |
| Elongation at break | 138 +/- 16% [per ISO 527} | >110% [Ref ASTM D638; pass, per design requirements] | |
| Ultimate Flexural Strength | 37.3 +/- MPa [per ASTM D790] | 44-47 MPa [Ref ASTM D790; pass, per design requirements] | |
| Ultimate Flexural Modulus | 1,107 +/- 37 MPa [per ASTM D790] | 1,100-1,400 MPa [Ref ASTM D790; pass, per design requirements] | |
| IZOD Impact (notched) | 70.7 +/- 12.1 J/m [per ASTM D256, method A] | 45-48 J/m [Ref ASTM D256; pass, per design requirements] | |
| Shore D hardness | 76 +/- 2% [per ASTM D2240] | 80-85 MPa [Ref ASTM D2240; pass per design requirements] | |
| VII PERFORMANCE AND SAFETY TESTING | | | |
| Animal Testing: | This product category does not require animal testing. | | |
| Clinical Testing: | This product category does not require human clinical testing. | | |
| Laboratory Testing: | Testing of above characteristics was conducted to evaluate the performance of the printed splint, according to requirements of DIN EN ISO 20795-2:2013, <i>Dentistry - Base Polymers - Part 2: Orthodontic base polymers</i> and according to DIN EN ISO 527-1, <i>Plastics - Determination of Tensile Properties</i> . All requirements were met. | | |
| Shelf Life Testing: | The resin has been validated real time for a shelf life of 18 months, stored in the original packaging at temperatures between 5° to 30° C. Resin properties evaluated included: viscosity, photoreactivity, and visual inspection of color change. | | |
| Biocompatibility Testing: | A biocompatibility risk assessment was developed and presented in the 510(k). As a result, the following ISO 10993 tests were conducted, according to Good Laboratory Practices, by an independent laboratory. The testing demonstrated that SmileGuardTM printed and tested samples are biocompatible and non-toxic and meet the requirements for a device in contact with mucosal membrane for >30 days:<br>• Cytotoxicity Studies Using ISO Elution Method (Part 5)<br>• Guinea Pig Maximization Sensitization Test (Part 10)<br>• Intracutaneous Tests for Irritation and Skin Sensitization in Rabbits (Part 10) | | |
| Additive Manufacturing | Testing, according to FDA's guidance <i>Technical Considerations for Additive Manufactured Medical Devices</i> , was performed and results were provided in the 510(k). These tests included evaluation of all relevant properties of the printed resin using the permitted machines. Further, tests based on considerations of the orientation during manufacturing were performed. | | |

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#### VIII COMPARISON TO THE PREDICATE DEVICE OF TECHNOLOGICAL CHARACTERISTICS

The intended use, critical specifications, and additive method of manufacturing SmileGuard™ resin are substantially equivalent to the Predicate device.

While the SmileGuard™ proprietary resin is different from the Predicate, both are lightcurable acrylate/methacrylate resins used in additive manufacturing and are of the same material category, commonly used for fabricating customized dental splints. The additive manufacturing processes both use the named resins, and validated scanners, printers and curing units.

The differences, in comparison to the Predicate device, raise no new questions of safety and effectiveness.

## VIX CONCLUSION

EnvisionTEC's analysis of SmileGuard™ compared to the Predicate show they have the same intended uses, and the technological parameters which are similar and meet the requirements of ISO 20795-2:2003, and ISO 527-1.

Based on the comparisons provided and the data submitted in this 510(k), it can be concluded the SmileGuard™ resin is substantially equivalence to the Predicate KeyPrint® KeySplint Soft™ resin device.