(74 days)
SmileGuard™ light curable resin is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards and splints.
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.
The provided text describes the 510(k) premarket notification for a device named "SmileGuard™", a light-curable resin for fabricating orthodontic and dental appliances. The document is primarily focused on demonstrating substantial equivalence to a predicate device (KeyPrint® KeySplint Soft™) through comparative testing of material properties, rather than an AI-driven medical device requiring clinical performance studies directly involving AI.
Therefore, many of the requested fields regarding acceptance criteria, study design for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment for AI models are not applicable to this specific device and the information provided. The document focuses on the physical and chemical properties of the resin, its biocompatibility, and manufacturing process.
Here's a breakdown of the provided information relevant to your request, with an explanation of why other aspects are not present:
Device Description:
SmileGuard™ is a light-curable resin used with a scanner, design software, validated 3D printer, and curing unit for the additive manufacture of dental appliance splints/mouth guards.
Intended Use:
Fabrication of orthodontic and dental appliances such as mouthguards, nightguards, and splints.
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are not performance metrics in the sense of diagnostic accuracy (like sensitivity/specificity for AI), but rather material property specifications and biocompatibility requirements for the resin. The acceptance criteria are based on established ISO and ASTM standards for dental polymers and biocompatibility.
| Characteristic | Acceptance Criteria (Predicate / Standard Requirement) | Reported Device Performance (SmileGuard™) | Unit | Test Standard |
|---|---|---|---|---|
| Tensile Strength | Unknown (but acceptable for predicate) | 19.1 +/- 2.5 | MPa | ISO 527 |
| Tensile Modulus | Unknown (but acceptable for predicate) | 319 +/- 48 | MPa | ISO 527 |
| Elongation at Break | >110% [Ref ASTM D638; pass, per design requirements] | 138 +/- 16% | % | ISO 527 |
| Ultimate Flexural Strength | 44-47 MPa [Ref ASTM D790; pass, per design requirements] | 37.3 +/- MPa (Note: reported as 37.3 +/- MPa) | MPa | ASTM D790 |
| Ultimate Flexural Modulus | 1,100-1,400 MPa [Ref ASTM D790; pass, per design requirements] | 1,107 +/- 37 | MPa | ASTM D790 |
| IZOD Impact (notched) | 45-48 J/m [Ref ASTM D256; pass, per design requirements] | 70.7 +/- 12.1 | J/m | ASTM D256, method A |
| Shore D Hardness | 80-85 MPa [Ref ASTM D2240; pass per design requirements] | 76 +/- 2% (Note: reported as 76 +/- 2%) | % (or Shore D) | ASTM D2240 |
| Biocompatibility | Meets requirements for mucosal membrane contact >30 days (ISO 10993) | Biocompatible and non-toxic | N/A | ISO 10993 (Parts 5 & 10) |
| Shelf Life | Stability for 18 months at 5°-30°C (viscosity, photoreactivity, visual inspection) | Validated real time for 18 months | N/A | Internal Validation (real-time stability) |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a laboratory testing program as outlined in Section VII of the 510(k) Summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the number of samples (e.g., number of test specimens) used for each physical property test (Tensile, Flexural, Impact, Hardness). It provides mean values and standard deviations, implying multiple samples were tested for each property.
- Data Provenance: The testing was conducted in a laboratory setting. No information about country of origin of data is provided beyond the manufacturer and regulatory consultant being based in Germany and the US respectively. The tests performed are prospective bench tests (physical property measurements and biocompatibility testing on newly manufactured resin samples).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. This is not a study involving human interpretation of data for "ground truth" (e.g., medical image reading). The "ground truth" for material properties is established by the results of standardized physical and chemical tests performed in a laboratory, and for biocompatibility by the results of in vitro and in vivo biological tests according to ISO standards. No human expert "adjudication" of these test results in the sense of diagnostic interpretation is mentioned or required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication is relevant for human expert consensus in diagnostic studies (e.g., radiology reads), not for laboratory material testing or biocompatibility assessments.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a material for fabricating dental appliances, not an AI-driven diagnostic or assistive tool for human interpretation. Therefore, MRMC studies and assessment of human reader improvement with AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no standalone AI algorithm in the context of this device. The device is a material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is derived from objective, quantitative measurements obtained through standardized laboratory tests (e.g., ISO, ASTM standards for material properties) and biological test results for biocompatibility (ISO 10993 series). It is not based on expert consensus, pathology, or outcomes data in the usual clinical sense.
8. The sample size for the training set:
- Not applicable. This is not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an AI model.
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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 (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
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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 51D-45968 GladbeckGermany | |
| Contact Person:Email: | Ruediger van Bernum, Head of Applicationruediger.v.bernum@envisiontec.de | |
| Telephone: | +49 2043 9875 45 | |
| Date Prepared: | 22 March 2022 | |
| II. DEVICE | ||
| Trade Name: | SmileGuard™ | |
| Common Name | Mouthguard, Prescription | |
| Regulatory NameClassificationProduct Codes | Mouthguard, PrescriptionUnclassifiedMQC | Positioner, Tooth, Preformed21 CFR 872.5525, Class 1KMY |
| III. PREDICATE DEVICE | ||
| Primary PredicateDevice: | K183598, KeyPrint® KeySplint Soft™, Keystone Industries | |
| IV. INDICATIONS FOR USE STATEMENTSmileGuard™ light curable resin is indicated for the fabrication of orthodontic and dentalappliances such as mouthguards, nightguards and splints. | ||
| V. DEVICE DESCRIPTION | ||
| Deviceldentificationand | The SmileGuard™ system combines the light-curable resin, for usewith a scanner with design software, validated 3D printer and acuring unit. These components are used together during theadditive manufacture of dental appliance splints/mouth guards. | |
| TechnologicalCharacteristics | The light-curing resin is a proprietary composition of acrylate/methacrylate, methacrylated oligomers and monomers, photoinitiators, colorants/dyes and absorbers. It is used by dentallaboratories and dental practices to make customized bite splints,using the 3D-printer. | |
| The resin is filled in lightproof 1 kg PE bottles labeled and offeredtogether with a programmed RFID chip (referred to as TAG), whichis required for use with the validated EnvisionTEC 3D printers. TheTAG contains information identifying the resin: material, name andamount. |
.
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| 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 bulbPerfactory® DDP4Printers with LEDPerfactory® Vida 2Perfactory® Vida 2 Hi-RESPerfactory® Vida HD cDLMPerfactory® Vida cDLMPerfactory® P4K 35,62,75,90Perfactory® MicroPlusXLPerfactory® EnvisionOne cDLMPerfactory® D4K |
| VI. SUBSTANTIAL EQUIVALENCE COMPARISON TABLE | |||
|---|---|---|---|
| NEW DEVICE | PRIMARY PREDICATE | ||
| 510(k) NUMBER;DEVICE NAME;MANUFACTURER | Not yet assignedSmileGuard ™EnvisionTEC GmbH | K183598KeyPrint® KeySplint Soft™Keystone Industries | |
| PRODUCT CODEREGULATORY NAMECLASSIFICATION(21 CFR) | MQC KMYMouthguard, Positioner,Tooth,Prescription PreformedUnclassified 872.5525,Class 1 | MQC KMYMouthguard, Positioner,Tooth,Prescription PreformedUnclassified 872.5525,Class 1 | |
| INDICATIONS FORUSE | SmileGuard™ light curable resinis indicated for the fabrication oforthodontic and dentalappliances such asmouthguards, nightguards andsplints. | The KeyPrint® KeySplint Soft™device is indicated for thefabrication of orthodontic anddental appliances such asmouthguards, nightguards,splints and repositioners. | |
| INGREDIENTS | Light-curing Resin | Light-curing Resin | |
| MANUFACTURINGTECHNOLOGY TYPE | Additive | Additive | |
| Sterility | Non-sterile | Non-sterile | |
| Biocompatibility | Biocompatible, according to ISO10993 testing | Biocompatible, according to ISO10993 testing | |
| PRODUCTCHARACTERISTICS: | Sample conditioned for 24 hr afterprinting: | ||
| 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.
N/A