← Product Code MQC · K201173
# E-Guard (K201173)
_Envisiontec GmbH · MQC · Nov 27, 2020 · DE · SESE_
**Canonical URL:** https://fda.innolitics.com/device/K201173
## Device Facts
- **Applicant:** Envisiontec GmbH
- **Product Code:** MQC
- **Decision Date:** Nov 27, 2020
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** DE
- **Attributes:** Therapeutic
## Intended Use
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 Story
E-Guard is a light-cured resin used in additive manufacturing (3D printing) to create dental appliances; specifically bite guards and occlusal night guards. The system requires a scanner, design software, a compatible EnvisionTEC 3D printer, and a curing unit. The resin is supplied in lightproof bottles with a programmed chip (TAG) that identifies the material to the printer. Dental laboratories or practices use the system to produce customized appliances. The device transforms digital scan data into physical polymer structures via light-curing. The output is a patient-specific dental splint. The device benefits patients by providing a customized therapeutic restoration for bite-related conditions. It is an alternative to traditional heat-cured or auto-polymerizing resins.
## Clinical Evidence
No clinical data. Bench testing only. Performance evaluated per DIN EN ISO 20795-2:2013 (flexural strength, flexural modulus, water solubility, water sorption). Biocompatibility testing performed per ISO 10993. Additive manufacturing process validated per FDA guidance.
## Technological Characteristics
Light-curing resin composed of acrylate/methacrylate, methacrylated oligomers/monomers, photo initiators, colorants/dyes, and absorbers. Non-sterile. Compatible with EnvisionTEC Perfactory DDP series printers (bulb or LED). Requires programmed chip (TAG) for printer operation. Complies with DIN EN ISO 20795-2:2013.
## Predicate Devices
- VeriSplint, Whip Mix Corporation ([K190107](/device/K190107.md))
## Reference Devices
- e-DENT Temporary Resin and Extra-Oral Curing System, DeltaMed GmbH ([K102776](/device/K102776.md))
## Submission Summary (Full Text)
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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
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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
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## Indications for Use
510(k) Number (if known) K201173
Device Name
E-Guard
Indications for Use (Describe)
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.
| 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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#
| I. SUBMITTER | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Submitter Name: | EnvisionTEC GmbH | | |
| Submitter Address: | Brusseler Straße 51
D-45968 Gladbeck
Germany | | |
| 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 Classification
Product Codes | Mouthguard, Prescription
Unclassified
MQC Resin, Denture, Relining,
Repairing, Rebasing
21 CFR 872.3760, Class 2
EBI | | |
| III. PREDICATE DEVICE | | | |
| Primary
Predicate Device: | K190107: VeriSplint, Whip Mix Corporation | | |
| Reference Device
Information: | K102776: e-DENT Temporary Resin and Extra-Oral Curing System,
DeltaMed GmbH [Product Code: EBG, Temporary Crown and
Bridge 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 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. | | | |
| V. DEVICE DESCRIPTION | | | |
| Device
Identification | 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. | | |
| Technological
Characteristics | 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. | | |
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| | 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. | | | | |
| | EnvisionTECs Perfactory® DDP (Digital Dental Printer) models
designed for use with the E-Guard light cured resin are: | | | | |
| | Printers with bulb
Perfactory® DDP4 XL
Perfactory® Desktop DDP plus
Perfactory® Desktop Pixera plus
Perfactory® DDP4 M
Perfactory® DDP Mini
Perfactory® DDP Mini XL | | | | |
| 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 | | | | | |
| VI. SUBSTANTIAL EQUIVALENCE COMPARISON TABLE | | | | | |
| | | NEW DEVICE | | PRIMARY PREDICATE | |
| 510(k) NUMBER;
DEVICE NAME;
MANUFACTURER | Not yet assigned | E-Guard
EnvisionTEC GmbH | | K190107
VeriSplint
Whip Mix Corporation | |
| PRODUCT CODE | MQC | EBI | MQC | EBI | |
| REGULATORY
NAME | Prescription
Mouthguard | Resin, Denture | Prescription
Mouthguard | Resin, Denture | |
| CLASSIFICATION (21
CFR) | Unclassified | 872.3760
Class II | Unclassified | 872.3760
Class II | |
| INDICATIONS FOR
USE | 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
guards/splints using the Additive
Manufacturing process. The resin
in combination with a scanner,
printer, and curing unit make up the
system. | | Whip Mix VeriSplint is a light-cured
resin. It is an orthodontic base
polymer used to create removable
structures for therapeutic
restorations like bite guards/splints
and occlusal night guards/splints
using the Additive Manufacturing
process. The resin in combination
with a scanner, printer, and curing
unit make up the system. | | |
| INGREDIENTS | Light-cured Resin | | Light-cured Resin | | |
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| PRODUCT
CHARACTERISTICS: | | | |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|--|
| 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 ISO
10993 testing | Biocompatible, according to ISO
10993 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. | | |
| Laboratory
Testing: | Testing was conducted to evaluate the performance of a
manufactured bite splint, according to requirements of DIN EN ISO
20795-2:2013, Dentistry - Base Polymers - Part 2: Orthodontic
base polymers. The requirements for flexural strength, flexural
modulus, 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. | | |
| Biocompatibility
Testing: | Testing, according to ISO 10993, confirms that E-Guard is
biocompatible and non-toxic and meets the requirements for a
device in contact with mucosal membrane for >30 days. | | |
| 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. | | |
## 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.
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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.
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**Source:** [https://fda.innolitics.com/device/K201173](https://fda.innolitics.com/device/K201173)
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