No
The summary describes a system for manufacturing dental appliances using 3D printing and a specific resin. It mentions a scanner and design software, but there is no indication or mention of AI or ML being used in the design process, image processing, or any other part of the system. The testing focuses on material properties and manufacturing standards, not algorithmic performance.
Yes.
It is used to create removable structures for therapeutic restorations, such as bite guards/splints and occlusal night guard/splints.
No
This device is a light-cured resin used to create removable dental structures like bite guards/splints. It is a material for manufacturing therapeutic restorations, not a diagnostic tool used to identify or analyze a disease or condition.
No
The device is a system that includes hardware components (scanner, printer, curing unit) and a physical resin material, not solely software.
Based on the provided information, the EnvisionTEC E-Guard resin itself is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- E-Guard's Intended Use: The intended use of E-Guard is to create removable structures for therapeutic restorations, specifically bite guards/splints and occlusal night guard/splints. These are physical devices used in the mouth, not tests performed on samples from the body.
- Device Description: The description clearly states that E-Guard is a light-cured resin used to manufacture dental appliances.
- Performance Studies: The performance studies focus on the physical properties of the manufactured splint (flexural strength, water solubility, etc.) and the biocompatibility of the material, not on diagnostic accuracy or the detection of any biological markers.
While the E-Guard system includes a scanner, which might be used to scan the patient's mouth (an in vivo process), the resin itself and the final manufactured device are not used for in vitro diagnostic purposes. They are therapeutic devices.
N/A
Intended Use / Indications for 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.
Product codes
MQC, EBI
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. 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
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: Laboratory Testing
Sample size: Not specified (Testing of 2 samples for bending strength and modulus)
Key results: 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.
Study type: Shelf Life Testing
Sample size: Not specified
Key results: 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.
Study type: Biocompatibility Testing
Sample size: Not specified
Key results: 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.
Study type: Additive Manufacturing
Sample size: Not specified
Key results: 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
Water Solubility: 0.5 ug/mm³
Water Sorption: 37 ug/mm³
Bending Strength:
(1) 85.1 MPa
(2) 79.4 MPa
Bending Modulus:
(1) 2130 MPa
(2) 2052 MPa
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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)
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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3
| 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. |
4
| | 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 | | |
5
| PRODUCT
| CHARACTERISTICS: | |||
|---|---|---|---|
| Sterility | Non-sterile | Non-sterile | |
| Water Solubility | 0.5 ug/mm³ | 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.
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.