E-Guard by EnvisionTEC GmbH | FDA 510(k) Summary

EnvisionTEC's E-Guard is a light-cured resin. It is a polymer used to create removable structures for therapeutic restorations, i.e. bite guards/splints and occlusal night guard/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.

Device Description

The E-Guard system combines a scanner with design software, the light-cured resin, a 3D printer and a curing unit. These components are used together during the manufacture of the dental appliance splint/bite guard. The light-curing resin is composed 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 offered in lightproof 1 kg PE bottles along with a programmed chip (referred to as TAG), which is required for use with the 3D printer. The TAG contains information identifying the resin material, name and amount. The E-Guard resin is an alternative material to heat-cured and auto-polymerizing resins.

AI/ML Overview

The provided text describes the acceptance criteria and a study proving the substantial equivalence of the E-Guard device to a predicate device, VeriSplint.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from DIN EN ISO 20795-2:2013 for Orthodontic base polymers)	Reported E-Guard Device Performance (based on testing of 2 samples from the same lot)	Predicate Device (VeriSplint) Performance
Water Solubility	0.5 ug/mm³	< 1 ug/mm³
Water Sorption	37 ug/mm³	29 ug/mm³
Bending Strength	(1) 85.1 MPa; (2) 79.4 MPa	> 100 MPa
Bending Modulus	(1) 2130 MPa; (2) 2052 MPa	> 2500 MPa
Biocompatibility	Biocompatible, according to ISO 10993 testing (meets requirements for device in contact with mucosal membrane for >30 days)	Biocompatible, according to ISO 10993 testing
Sterility	Non-sterile	Non-sterile
Shelf Life	Validated real-time for 1 year (viscosity, reactivity, homogeneity, color change tested)	Not explicitly detailed but implied
Additive Manufacturing Considerations	Evaluated according to FDA's guidance, including relevant properties and orientation during manufacturing	Not explicitly detailed but implied

Note: The document states that "The requirements for flexural strength, flexural modulus, water solubility and water sorption content were met" by the E-Guard device, even though some reported values are quantitatively different from the predicate or general acceptance criteria. This suggests the criteria itself may have a range or different specific thresholds that were met. For instance, the predicate's bending strength is stated as "> 100 MPa", and the E-Guard's values (85.1 MPa, 79.4 MPa) are lower. However, the conclusion still states the requirements were met, implying that the specific ISO standard allows for this difference or the context of the comparison focuses on overall substantial equivalence rather than identical performance values in every aspect.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: For explicit physical properties like Bending Strength and Bending Modulus, the document mentions "Testing of 2 samples, same lot". The overall number of manufactured bite splints used for the performance evaluation according to DIN EN ISO 20795-2:2013 is not explicitly stated, beyond stating "Testing was conducted to evaluate the performance of a manufactured bite splint."
Data Provenance: Not explicitly stated, but likely from internal laboratory testing conducted by EnvisionTEC GmbH, a German company ("D-45968 Gladbeck Germany"). The tests were performed according to ISO standards, which are international. It is a retrospective study in the context of this 510(k) submission, as the data was collected prior to the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The ground truth for the physical and biocompatibility testing is based on established international standards (DIN EN ISO 20795-2:2013 and ISO 10993) rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

This information is not applicable as the 'ground truth' is determined by quantitative measurements against ISO standards for material properties and biocompatibility, not by expert review of individual cases requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a dental material, and the evaluation focuses on its physical and biological properties, not a diagnostic or interventional imaging tool that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. The device is a light-cured resin used in an Additive Manufacturing process for dental appliances. It is a material, not a software algorithm, so "standalone" performance in the context of AI algorithms is not relevant. The performance evaluation is of the material itself and the manufacturing process.

7. The Type of Ground Truth Used

The ground truth used for performance validation is based on established international standards for dental materials:

DIN EN ISO 20795-2:2013, Dentistry - Base Polymers - Part 2: Orthodontic base polymers: For flexural strength, flexural modulus, water solubility, and water sorption content.
ISO 10993: For biocompatibility.

8. The Sample Size for the Training Set

Not Applicable. As a physical material evaluated against defined standards, there is no "training set" in the context of machine learning or AI models. The material's properties are inherent to its composition and manufacturing process, not learned from data in a training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. (Refer to point 8).

Summary

{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.

November 27, 2020

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

Re: K201173

Trade/Device Name: E-Guard Regulatory Class: Unclassified Product Code: MQC, EBI Dated: August 27, 2020 Received: August 31, 2020

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

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K201173

Device Name

E-Guard

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

I. SUBMITTER
Submitter Name:	EnvisionTEC GmbH
Submitter Address:	Brusseler Straße 51D-45968 GladbeckGermany
Contact Person:	Ruediger van Bernum, Head of Application
Email:	ruediger.v.bernum@envisiontec.de
Date Prepared:	November 25, 2020
II. DEVICE
Trade Name:	E-Guard
Common Name	Mouthguard, Prescription; Dental Resin
Regulatory Name ClassificationProduct Codes	Mouthguard, PrescriptionUnclassifiedMQC Resin, Denture, Relining,Repairing, Rebasing21 CFR 872.3760, Class 2EBI
III. PREDICATE DEVICE
PrimaryPredicate Device:	K190107: VeriSplint, Whip Mix Corporation
Reference DeviceInformation:	K102776: e-DENT Temporary Resin and Extra-Oral Curing System,DeltaMed GmbH [Product Code: EBG, Temporary Crown andBridge Resin, 21 CFR 872.3770]
IV. INDICATIONS FOR USE STATEMENT
EnvisionTEC's E-Guard is a light-cured resin. It is a polymer used to create removablestructures for therapeutic restorations, i.e. bite guards/splints and occlusal nightguard/splints using the Additive Manufacturing process. The resin in combination with ascanner, printer, and curing unit make up the system.
V. DEVICE DESCRIPTION
DeviceIdentification	The E-Guard system combines a scanner with design software, thelight-cured resin, a 3D printer and a curing unit. These componentsare used together during the manufacture of the dental appliancesplint/bite guard.
TechnologicalCharacteristics	The light-curing resin is composed of acrylate/methacrylate,methacrylated oligomers and monomers, photo initiators,colorants/dyes and absorbers. It is used by dental laboratories anddental practices to make customized bite splints, using the 3D-printer.

{4}------------------------------------------------

	The resin is offered in lightproof 1 kg PE bottles along with aprogrammed chip (referred to as TAG), which is required for usewith the 3D printer. The TAG contains information identifying theresin material, name and amount.
	The E-Guard resin is an alternative material to heat-cured and auto-polymerizing resins.
	EnvisionTECs Perfactory® DDP (Digital Dental Printer) modelsdesigned for use with the E-Guard light cured resin are:
	Printers with bulbPerfactory® DDP4 XLPerfactory® Desktop DDP plusPerfactory® Desktop Pixera plusPerfactory® DDP4 MPerfactory® DDP MiniPerfactory® DDP Mini XL
Printers with LEDPerfactory® Vida 2Perfactory® Vida 2 Hi-RESPerfactory® Vida HD cDLMPerfactory® Vida cDLMPerfactory® P4K 35,62,75,90Perfactory® MicroPlusXLPerfactory® EnvisionOne cDLM
VI. SUBSTANTIAL EQUIVALENCE COMPARISON TABLE
		NEW DEVICE		PRIMARY PREDICATE
510(k) NUMBER;DEVICE NAME;MANUFACTURER	Not yet assigned	E-GuardEnvisionTEC GmbH		K190107VeriSplintWhip Mix Corporation
PRODUCT CODE	MQC	EBI	MQC	EBI
REGULATORYNAME	PrescriptionMouthguard	Resin, Denture	PrescriptionMouthguard	Resin, Denture
CLASSIFICATION (21CFR)	Unclassified	872.3760Class II	Unclassified	872.3760Class II
INDICATIONS FORUSE	E-Guard is a light-cured resin. It isa polymer used to createremovable structures fortherapeutic restorations, i.e. biteguards/splints and occlusal nightguards/splints using the AdditiveManufacturing process. The resinin combination with a scanner,printer, and curing unit make up thesystem.		Whip Mix VeriSplint is a light-curedresin. It is an orthodontic basepolymer used to create removablestructures for therapeuticrestorations like bite guards/splintsand occlusal night guards/splintsusing the Additive Manufacturingprocess. The resin in combinationwith a scanner, printer, and curingunit make up the system.
INGREDIENTS	Light-cured Resin		Light-cured Resin

{5}------------------------------------------------

PRODUCTCHARACTERISTICS:
Sterility	Non-sterile	Non-sterile
Water Solubility	0.5 ug/mm³	< 1 ug/mm3
Water Sorption	37 ug/mm³	29 ug/mm³
Bending Strength	Testing of 2 samples, same lot:(1) 85.1 MPa;(2) 79.4 MPa	> 100 MPa
Bending Modulus	Testing of 2 samples, same lot:(1) 2130 MPa;(2) 2052 MPa	> 2500 MPa
Biocompatibility	Biocompatible, according to ISO10993 testing	Biocompatible, according to ISO10993 testing
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.
LaboratoryTesting:	Testing was conducted to evaluate the performance of amanufactured bite splint, according to requirements of DIN EN ISO20795-2:2013, Dentistry - Base Polymers - Part 2: Orthodonticbase polymers. The requirements for flexural strength, flexuralmodulus, water solubility and water sorption content were met.
Shelf Life Testing:	The resin has been validated real time for a shelf life of 1 year,stored in the original packaging at temperatures between 5° to 30°C. Properties tested include: material viscosity, material reactivity,material homogeneity and color change.
BiocompatibilityTesting:	Testing, according to ISO 10993, confirms that E-Guard isbiocompatible and non-toxic and meets the requirements for adevice in contact with mucosal membrane for >30 days.
AdditiveManufacturing	Testing, according to FDA's guidance Technical Considerations forAdditive Manufactured Medical Devices, was performed and resultswere provided in the 510(k). These tests included evaluation of allrelevant properties of the printed resin using the permittedmachines. Further, tests based on considerations of the orientationduring manufacturing were performed.

VIII COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The intended use, critical specifications, and additive method of manufacturing of E-Guard are substantially equivalent to the predicate device, VeriSplint.

While the resin of the predicate is different from E-Guard, both are photo-curable resins used in additive manufacturing and are of the same material category. The additive manufacturing processes both use a resin, scanner, printer and curing unit.

{6}------------------------------------------------

The testing performed by EnvisionTEC, compared to that reported for the predicate, Whip Mix, produced results that are similar to the predicate.

In addition, the E-Guard also is similar technologically to the reference device: K102776, DeltaMed e-DENT, which uses a photo-curable resin, similar design software and scanner, as well as the same type of printer software and 3D-printer.

The noted differences, in comparison to the predicate device, raise no new questions.

VIX CONCLUSION

Based on the comparisons provided and the data submitted in this 510(k), it can be concluded E-Dent is substantially equivalence to VeriSplint predicate device. EnvisionTEC's analysis of E-Guard compared to the predicate show they have the same intended use, and the technological parameters meet the requirements of ISO 20795-2:2003.

Regulation Number and Section

N/A