(74 days)
Not Found
No
The description focuses on the material composition, manufacturing process (3D printing), and physical properties of the resin, with no mention of AI or ML in the design software or any other part of the system.
Yes.
The device is used for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, and splints, which are used to treat conditions and provide therapy.
No
Explanation: The device description states it is a light-curable resin for fabricating orthodontic and dental appliances (mouthguards, nightguards, splints). Its intended use is for manufacturing, not for diagnosing a medical condition.
No
The device description clearly states it is a light-curable resin and part of a system that includes a scanner, 3D printer, and curing unit, all of which are hardware components. The performance studies also focus on the physical properties of the printed resin.
Based on the provided information, the SmileGuard™ light curable resin is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, and splints. These are devices that are placed in or on the body for therapeutic or protective purposes.
- Device Description: The description clearly states it's a light-curing resin used in the additive manufacture of dental appliance splints/mouth guards. It's a material used to create a physical device.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
IVD devices are typically used to test samples like blood, urine, or tissue to detect diseases, infections, or other health conditions. The SmileGuard™ resin is a material used to create a physical medical device, not a diagnostic tool.
N/A
Intended Use / Indications for Use
SmileGuard™ light curable resin is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards and splints.
Product codes (comma separated list FDA assigned to the subject device)
MQC, KMY
Device Description
The SmileGuard™ system combines the light-curable resin, for use with a scanner with design software, validated 3D printer and a curing unit. These components are used together during the additive manufacture of dental appliance splints/mouth guards.
The light-curing resin is a proprietary composition of acrylate/methacrylate, methacrylated oligomers and monomers, photo initiators, colorants/dyes and absorbers. It is used by dental laboratories and dental practices to make customized bite splints, using the 3D-printer.
The resin is filled in lightproof 1 kg PE bottles labeled and offered together with a programmed RFID chip (referred to as TAG), which is required for use with the validated EnvisionTEC 3D printers. The TAG contains information identifying the resin: material, name and amount.
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:
Printers with bulb
Perfactory® DDP4
Printers with LED
Perfactory® Vida 2
Perfactory® Vida 2 Hi-RES
Perfactory® Vida HD cDLM
Perfactory® Vida cDLM
Perfactory® P4K 35,62,75,90
Perfactory® MicroPlusXL
Perfactory® EnvisionOne cDLM
Perfactory® D4K
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental laboratories and dental practices
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)
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, Dentistry - Base Polymers - Part 2: Orthodontic base polymers and according to DIN EN ISO 527-1, Plastics - Determination of Tensile Properties . 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:
• Cytotoxicity Studies Using ISO Elution Method (Part 5)
• Guinea Pig Maximization Sensitization Test (Part 10)
• Intracutaneous Tests for Irritation and Skin Sensitization in Rabbits (Part 10)
Additive Manufacturing: Testing, according to FDA's guidance Technical Considerations for Additive Manufactured Medical Devices , 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Tensile Strength: 19.1 +/- 2.5 MPa [per ISO 527]
Tensile Modulus: 319 +/- 48 MPA [per ISO 527]
Elongation at break: 138 +/- 16% [per ISO 527}
Ultimate Flexural Strength: 37.3 +/- MPa [per ASTM D790]
Ultimate Flexural Modulus: 1,107 +/- 37 MPa [per ASTM D790]
IZOD Impact (notched): 70.7 +/- 12.1 J/m [per ASTM D256, method A]
Shore D hardness: 76 +/- 2% [per ASTM D2240]
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
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
510(k) Number (if known)
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| I. SUBMITTER | ||
|---|---|---|
| Submitter Name: | EnvisionTEC GmbH | |
| Submitter Address: | Brusseler Straße 51 | |
| D-45968 Gladbeck | ||
| Germany | ||
| Contact Person: | ||
| Email: | Ruediger van Bernum, Head of Application | |
| ruediger.v.bernum@envisiontec.de | ||
| Telephone: | +49 2043 9875 45 | |
| Date Prepared: | 22 March 2022 | |
| II. DEVICE | ||
| Trade Name: | SmileGuard™ | |
| Common Name | Mouthguard, Prescription | |
| Regulatory Name | ||
| Classification | ||
| Product Codes | Mouthguard, Prescription | |
| Unclassified | ||
| MQC | Positioner, Tooth, Preformed | |
| 21 CFR 872.5525, Class 1 | ||
| KMY | ||
| III. PREDICATE DEVICE | ||
| Primary Predicate | ||
| Device: | K183598, KeyPrint® KeySplint Soft™, Keystone Industries | |
| IV. INDICATIONS FOR USE STATEMENT | ||
| SmileGuard™ light curable resin is indicated for the fabrication of orthodontic and dental | ||
| appliances such as mouthguards, nightguards and splints. | ||
| V. DEVICE DESCRIPTION | ||
| Device | ||
| ldentification | ||
| and | The SmileGuard™ system combines the light-curable resin, for use | |
| with a scanner with design software, validated 3D printer and a | ||
| curing unit. These components are used together during the | ||
| additive manufacture of dental appliance splints/mouth guards. | ||
| Technological | ||
| Characteristics | The light-curing resin is a proprietary composition of acrylate/ | |
| methacrylate, methacrylated oligomers and monomers, photo | ||
| initiators, colorants/dyes and absorbers. It is used by dental | ||
| laboratories and dental practices to make customized bite splints, | ||
| using the 3D-printer. | ||
| The resin is filled in lightproof 1 kg PE bottles labeled and offered | ||
| together with a programmed RFID chip (referred to as TAG), which | ||
| is required for use with the validated EnvisionTEC 3D printers. The | ||
| TAG contains information identifying the resin: material, name and | ||
| 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: |
| Printers with bulb |
| Perfactory® DDP4 |
| Printers with LED |
| Perfactory® Vida 2 |
| Perfactory® Vida 2 Hi-RES |
| Perfactory® Vida HD cDLM |
| Perfactory® Vida cDLM |
| Perfactory® P4K 35,62,75,90 |
| Perfactory® MicroPlusXL |
| Perfactory® EnvisionOne cDLM |
| Perfactory® D4K |
| VI. SUBSTANTIAL EQUIVALENCE COMPARISON TABLE | |||
|---|---|---|---|
| NEW DEVICE | PRIMARY PREDICATE | ||
| 510(k) NUMBER; | |||
| DEVICE NAME; | |||
| MANUFACTURER | Not yet assigned | ||
| SmileGuard ™ | |||
| EnvisionTEC GmbH | K183598 | ||
| KeyPrint® KeySplint Soft™ | |||
| Keystone Industries | |||
| PRODUCT CODE | |||
| REGULATORY NAME | |||
| CLASSIFICATION | |||
| (21 CFR) | MQC KMY | ||
| Mouthguard, Positioner,Tooth, | |||
| Prescription Preformed | |||
| Unclassified 872.5525, | |||
| Class 1 | MQC KMY | ||
| Mouthguard, Positioner,Tooth, | |||
| Prescription Preformed | |||
| Unclassified 872.5525, | |||
| Class 1 | |||
| INDICATIONS FOR | |||
| USE | SmileGuard™ light curable resin | ||
| is indicated for the fabrication of | |||
| orthodontic and dental | |||
| appliances such as | |||
| mouthguards, nightguards and | |||
| splints. | The KeyPrint® KeySplint Soft™ | ||
| device is indicated for the | |||
| fabrication of orthodontic and | |||
| dental appliances such as | |||
| mouthguards, nightguards, | |||
| splints and repositioners. | |||
| INGREDIENTS | Light-curing Resin | Light-curing Resin | |
| MANUFACTURING | |||
| TECHNOLOGY TYPE | Additive | Additive | |
| Sterility | Non-sterile | Non-sterile | |
| Biocompatibility | Biocompatible, according to ISO | ||
| 10993 testing | Biocompatible, according to ISO | ||
| 10993 testing | |||
| PRODUCT | |||
| CHARACTERISTICS: | Sample conditioned for 24 hr after | ||
| 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, Dentistry - Base Polymers - Part 2: Orthodontic base polymers and according to DIN EN ISO 527-1, Plastics - Determination of Tensile Properties . 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: | ||
| • Cytotoxicity Studies Using ISO Elution Method (Part 5) | |||
| • Guinea Pig Maximization Sensitization Test (Part 10) | |||
| • Intracutaneous Tests for Irritation and Skin Sensitization in Rabbits (Part 10) | |||
| Additive Manufacturing | Testing, according to FDA's guidance Technical Considerations for Additive Manufactured Medical Devices , 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.