(62 days)
None
No
The summary describes a CAD/CAM system for fabricating temporary dental restorations using a light-curable resin and 3D printing. There is no mention of AI or ML being used in the design software, scanning process, or any other part of the system. The focus is on the material properties and the manufacturing process.
No
The device is a light-curable resin used for fabricating temporary dental restorations (crowns, partial crowns, and bridges) in dental laboratories. While these temporary restorations are applied to patients, the E-Temp resin itself is a material used for fabrication, not a device directly applied to a patient for a therapeutic effect. Its purpose is to create a physical object (temporary dental application), not to treat or cure a disease or condition.
No
Explanation: E-Temp is a light-curable resin used for the fabrication of temporary dental crowns and bridges. It is a material used in the manufacturing process of a medical device, not a device that diagnoses conditions.
No
The device description explicitly states that the E-Temp system combines a scanner, design software, light-curable resin, a 3D printer, and a curing unit. While software is a component, the system includes significant hardware (scanner, 3D printer, curing unit) and a physical material (light-curable resin) that are integral to the device's function.
Based on the provided information, the E-Temp device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the fabrication of temporary dental restorations (crowns and bridges) in dental laboratories. This is a manufacturing process for a medical device that will be placed in the patient's mouth.
- Device Description: The device is a system for 3D printing dental prosthetics. It involves a resin, a printer, and curing equipment.
- Lack of In Vitro Diagnostic Activities: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or screening. The input is digital dental files, not biological samples.
The device is a medical device used in the fabrication of temporary dental prosthetics, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
E-Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns and temporary bridges in dental laboratories. The material is an alternative to traditional restorative dental material. E-Temp is intended exclusively for professional dental work. Fabrication of dental applications with E-Temp requires a computer aided and manufacturing (CAD/CAM) system that includes the following components: digital dental files based on a digital impression or in case of artificial teeth for dental prostheses the digital dental files based on manufacturer's data, a digital light processing (DLP) printer, and curing light equipment.
Product codes (comma separated list FDA assigned to the subject device)
EBG
Device Description
The E-Temp system combines a scanner with design software, the light-curable resin, a 3D printer and a curing unit. These components are used together during the manufacture of the customized temporary crowns or bridges.
The light-curable resin is a proprietary composition of acrylates, methacrylates, methacrylated oligomers and monomers, photo initiators, colorants/dyes and absorbers. It is used by dental laboratories to make the customized temporary crowns and bridges for patients who need restoration of their natural teeth.
E-Temp is available in six different colors.
The resin is packaged in lightproof 1 kg PE bottles along with a programmed RFID chip (referred to as TAG), which is required for use with the validated 3D printers. The TAG contains information identifying the resin material, name and amount.
E-Temp resin is an alternative material to heat-curable and auto-polymerizable resins.
EnvisionTECs Perfactory® 3D-Printer DLP models designed and validated for use with the E-Temp light cured resin are:
• EnvisionOne cDLM, with LED
• Micro series, with LED
• Vida Series, with LED
• P4K Series, with LED
• D4K Series, with LED
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
professional dental work / dental laboratories
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)
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 manufactured temporary crowns and bridges, according to requirements of:
• DIN EN ISO 10477:2018: Dentistry—Polymer-based crown and veneering materials (type 2, class II),
• DIN EN ISO 4049:2019-09: Dentistry-Polymer-based restorative materials (type 1, class II, group 2),
• DIN EN ISO 7491: Dental materials-Determination of colour stability.
Including biocompatibility requirements, the following specification requirements of the 3D-printed material samples were tested and have been met:
• Surface quality
• Dimensional stability
• Color and color stability
• Translucency
• Flexural strength and flexural modulus
• Freedom from porosity
• Water Sorption
• Water Solubility
Shelf Life Testing: Validated accelerated shelf life testing of the E-Temp resin at time of 510(k) submission is 4 months. The resin is on real-time validation testing for an ultimate shelf life of 24 months, stored in the original packaging at temperatures at 30° C. Properties being tested include material viscosity, material photoreactivity and color change. The E-Temp resin also was tested for good transport stability.
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 a 3rd party contract laboratory.
Testing showed the E-Temp 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 Study Using ISO Elution Method (Part 5) Guinea Pig Maximization Sensitization Test (Part 10) Tests for Irritation and Skin Sensitization - Intracutaneous Injection in Rabbits (Part 10) Acute Systemic Toxicity Study in Mice (Part 11)
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.)
Not Found
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.
None
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
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION".
June 14, 2021
EnvisionTEC GmbH Patsy Trisler Regulatory Consultant Oserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250
Re: K211101
Trade/Device Name: E-Temp Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: April 9, 2021 Received: April 20, 2021
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 mav, 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
1
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 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 (OS) 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 -S
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) K211101
Device Name
E-Temp
Indications for Use (Describe)
E-Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns and temporary bridges in dental laboratories. The material is an alternative to traditional restorative dental material. E-Temp is intended exclusively for professional dental work. Fabrication of dental applications with E-Temp requires a computer aided and manufacturing (CAD/CAM) system that includes the following components: digital dental files based on a digital impression or in case of artificial teeth for dental prostheses the digital dental files based on manufacturer's data, a digital light processing (DLP) printer, and curing light equipment.
| 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
| K211101 | 510(k) Summary |
|---|---|
| --------- | ---------------- |
| I. SUBMITTER | |
|---|---|
| Submitter Name: | EnvisionTEC GmbH |
| Submitter | |
| Address: | Bruesseler 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: | 9 April 2021 |
| II. DEVICE | |
| Trade Name: | E-Temp |
| Common Name | Temporary Crown and Bridge Resin |
| Classification | |
| Number Name: | 21 CFR 872.3770 |
| Crown and Bridge, Temporary, Resin | |
| Product Code | EBG |
| Device Class | II |
| III. PREDICATE DEVICE | |
| Primary | |
| Predicate Device | K102776, e-DENT Temporary Resin and Extra-Oral Curing System, |
| DeltaMed GmbH | |
| Reference | |
| Device | None |
| IV. INDICATIONS FOR USE STATEMENT | E-Temp is a light-curable resin indicated for the fabrication of individual and fixed |
| temporary full single crowns, temporary partial crowns and temporary bridges in dental | |
| laboratories. The material is an alternative to traditional restorative dental material. E- | |
| Temp is intended exclusively for professional dental work. Fabrication of dental | |
| applications with E-Temp requires a computer aided and manufacturing (CAD/CAM) | |
| system that includes the following components: digital dental files based on a digital | |
| impression or in case of artificial teeth for dental prostheses the digital dental files based | |
| on manufacturer's data, a digital light processing (DLP) printer, and curing light | |
| equipment. | |
| V. DEVICE DESCRIPTION | |
| Device | |
| Identification | The E-Temp system combines a scanner with design software, the |
| light-curable resin, a 3D printer and a curing unit. These | |
| components are used together during the manufacture of the | |
| customized temporary crowns or bridges. | |
| Technological | |
| Characteristics | The light-curable resin is a proprietary composition of acrylates, |
| methacrylates, methacrylated oligomers and monomers, photo | |
| initiators, colorants/dyes and absorbers. It is used by dental | |
| laboratories to make the customized temporary crowns and bridges | |
| for patients who need restoration of their natural teeth. | |
| E-Temp is available in six different colors. | |
| The resin is packaged in lightproof 1 kg PE bottles along with a | |
| programmed RFID chip (referred to as TAG), which is required for | |
| use with the validated 3D printers. The TAG contains information | |
| identifying the resin material, name and amount. | |
| E-Temp resin is an alternative material to heat-curable and auto- | |
| polymerizable resins. | |
| EnvisionTECs Perfactory® 3D-Printer DLP models designed and | |
| validated for use with the E-Temp light cured resin are: | |
| • EnvisionOne cDLM, with LED | |
| • Micro series, with LED | |
| • Vida Series, with LED | |
| • P4K Series, with LED | |
| • D4K Series, with LED | |
| 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 |
| manufactured temporary crowns and bridges, according to | |
| requirements of: | |
| • DIN EN ISO 10477:2018: Dentistry—Polymer-based crown | |
| and veneering materials (type 2, class II), | |
| • DIN EN ISO 4049:2019-09: Dentistry-Polymer-based | |
| restorative materials (type 1, class II, group 2), | |
| • DIN EN ISO 7491: Dental materials-Determination of colour | |
| stability. | |
| Including biocompatibility requirements, the following specification | |
| requirements of the 3D-printed material samples were tested and | |
| have been met: | |
| • Surface quality | |
| • Dimensional stability | |
| • Color and color stability | |
| • Translucency | |
| • Flexural strength and flexural modulus | |
| • Freedom from porosity | |
| • Water Sorption | |
| • Water Solubility | |
| Shelf Life Testing: | Validated accelerated shelf life testing of the E-Temp resin at time |
| of 510(k) submission is 4 months. The resin is on real-time | |
| validation testing for an ultimate shelf life of 24 months, stored in | |
| the original packaging at temperatures at 30° C. Properties being | |
| tested include material viscosity, material photoreactivity and color | |
| change. The E-Temp resin also was tested for good transport | |
| stability. | |
| 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 a 3rd party | |
| contract laboratory. | |
| Testing showed the E-Temp 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 Study Using ISO Elution Method (Part 5) Guinea Pig Maximization Sensitization Test (Part 10) Tests for Irritation and Skin Sensitization - Intracutaneous | |
| Injection in Rabbits (Part 10) Acute Systemic Toxicity Study in Mice (Part 11) | |
| 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. |
4
5
VIII COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICES
The intended use, critical specifications, and additive method of manufacturing of E-Temp are substantially equivalent to the Predicate device.
While the E-Temp resin is different from the Predicate resin, both are photo-curable resins used in additive manufacturing and are of the same material category; and both use the same 3D printer and associated validated software.
The noted differences, in comparison to the predicate device, raise no new questions of safety and effectiveness.
VIX CONCLUSION
Based on the comparisons provided and the data submitted in this 510(k), it can be concluded E-Temp is substantially equivalent to the predicate device. EnvisionTEC's analysis of E-Temp show they have the same intended use, and similar technological parameters according to the characterization testing.