(54 days)
No
The description focuses on the material properties, manufacturing process (CAD/CAM, 3D printing), and performance testing of the resin and fabricated dental products. There is no mention of AI or ML being used in the design software, scanning process, or any other part of the system.
No
The device is a material (light-curable resin) used for fabricating dental prostheses, not a device that directly provides therapy.
No
Explanation: The device is a light-curable resin used for fabricating dental prostheses and restorations, which falls under manufacturing/fabrication rather than diagnosis.
No
The device description explicitly states that the E-Dent 1000 system combines a scanner, design software, light-curable resin, a 3D printer, and a curing unit. It also describes the physical resin material and its packaging. This indicates the device is a system with both hardware and software components, not software-only.
Based on the provided text, the E-Dent 1000 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the fabrication of dental prostheses (crowns, veneers, dentures, artificial teeth) for use in patients. This is a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The description details the components used in the manufacturing process of these dental products. It does not mention any components or processes related to analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical properties, biocompatibility, and manufacturing quality of the fabricated dental devices. They do not involve evaluating the device's ability to diagnose a condition or provide information about a patient's health status.
- Lack of Diagnostic Indicators: There is no mention of the device being used to detect, measure, or analyze any substances or characteristics in vitro (outside the body) for diagnostic purposes.
The E-Dent 1000 is a system for manufacturing custom dental restorations, which falls under the category of a medical device used for treatment and restoration, not diagnosis.
N/A
Intended Use / Indications for Use
E-Dent 1000 is a light-curable resin indicated for the fabrication of:
- · individual and fixed permanent full single crowns, permanent partial crowns in front and posterior area,
- · individual and fixed single veneers,
- · artificial teeth for dental prostheses, which are used for removable permanent full dentures,
- · individual and removable monolithic full and partial dentures
in dental laboratories. The material is an alternative dental material. E-Dent 1000 is intended exclusively for professional dental work. Fabrications with E-Dent 1000 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
EBF, EBI, ELM
Device Description
The E-Dent 1000 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 E-Dent 1000 restorative dental products. 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-Dent 1000 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-Dent 1000 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-Dent 1000 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
digital dental files based on a digital impression
Anatomical Site
Teeth, dental prostheses
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)
Lab Testing: Testing was conducted to evaluate the performance of manufactured crowns, artificial teeth, veneers and dentures, 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
- DIN EN ISO 20795-1:2009-02 Dentistry-Resins Part 1: Prosthetic resins.
Including biocompatibility requirements, the following specification requirements of the 3D-printed material samples were tested: 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-Dent 1000 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-Dent 1000 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. Testing showed the E-Dent 1000 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: 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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
May 25, 2021
EnvisionTEC GmbH Patsy Trisler Regulatory Consultant Oserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250
Re: K210977
Trade/Device Name: E-Dent 1000 Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, EBI, ELM Dated: March 29, 2021 Received: April 1, 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 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
1
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 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
2
Indications for Use
510(k) Number (if known) K210977
Device Name
E-Dent 1000
Indications for Use (Describe)
E-Dent 1000 is a light-curable resin indicated for the fabrication of:
- · individual and fixed permanent full single crowns, permanent partial crowns in front and posterior area,
- · individual and fixed single veneers,
- · artificial teeth for dental prostheses, which are used for removable permanent full dentures,
- · individual and removable monolithic full and partial dentures
in dental laboratories. The material is an alternative dental material. E-Dent 1000 is intended exclusively for professional dental work. Fabrications with E-Dent 1000 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) | |
|---|---|
| ------------------------------------------------- | -- |
X 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
510(k) Summary
| I. SUBMITTER | |||
|---|---|---|---|
| Submitter Name: | EnvisionTEC GmbH | ||
| Submitter Address: | Bruesseler Straße 51 | ||
| D-45968 Gladbeck | |||
| Germany | |||
| Contact Person: | Ruediger van Bernum, Head of Application | ||
| Email: | ruediger.v.bernum@envisiontec.de | ||
| Telephone: | +49 2043 9875 45 | ||
| Date Prepared: | March 29, 2021 | ||
| II. DEVICE | |||
| Trade Name: | E-Dent 1000 | ||
| Common Name | Tooth shade resin material, | ||
| Denture relining, repairing, rebasing resin, | |||
| Preformed plastic denture tooth | |||
| Classification | |||
| Numbers Names | |||
| Product Codes | |||
| Device Class | 21 CFR 872.3690 | ||
| Material, Tooth | |||
| Shade, Resin | |||
| EBF | |||
| II | 21 CFR 872.3760 | ||
| Resin, Denture, | |||
| Relining, Repairing, | |||
| Rebasing | |||
| EBI | |||
| II | 21 CFR 872.3590 | ||
| Denture, Plastic, | |||
| Teeth | |||
| ELM | |||
| II, 510(k)-Exempt | |||
| III. PREDICATE DEVICE | |||
| Predicate Devices | |||
| Primary Predicate | K201668, VarseoSmile Crown Plus, BEGO Bremer Goldschlagerei | ||
| Wilh. Herbst GmbH & Co. KG (EBF product code) | |||
| Secondary | |||
| Predicate | K151142, IvoBase CAD for Zenotec, IvoBase CAD Bond and | ||
| Modelling Liquid, Ivoclar Vivadent, Inc. (EBI product code) | |||
| Reference | |||
| Device(s) | K102776: e-DENT Temporary Resin and Extra-Oral Curing System, | ||
| DeltaMed GmbH | |||
| IV. INDICATIONS FOR USE STATEMENT | |||
| E-Dent 1000 is a light-curable resin indicated for the fabrication of: | |||
| • individual and fixed permanent full single crowns, permanent partial crowns in front | |||
| and posterior area. |
- individual and fixed single veneers,
- . artificial teeth for dental prostheses, which are used for removable permanent full dentures,
- individual and removable monolithic full and partial dentures ●
in dental laboratories. The material is an alternative to traditional restorative dental material. E-Dent 1000 is intended exclusively for professional dental work. Fabrication of dental applications with E-Dent 1000 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
4
| based on manufacturer's data, a digital light processing (DLP) printer, and curing light
| equipment. | |
|---|---|
| V. DEVICE DESCRIPTION | |
| Device | |
| Identification | The E-Dent 1000 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 E-Dent 1000 restorative dental products. |
| 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-Dent 1000 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-Dent 1000 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-Dent 1000 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 a manufactured crowns, artificial teeth, veneers and dentures, 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. | |
| • DIN EN ISO 20795-1:2009-02 Dentistry-Resins Part 1: Prosthetic resins. | |
| Including biocompatibility requirements, the following specification requirements of the 3D-printed material samples were tested and | |
| 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-Dent 1000 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-Dent 1000 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. |
Testing showed the E-Dent 1000 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. |
5
VIII COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICES
The intended use, technological characteristics and critical specifications, are similar to both Predicate devices. The additive method of manufacturing E-Dent 1000 is similar to Primary Predicate.
The intended use of fabrication of dental prosthetics is the same as both Predicates. The manufacture of the permanent crowns and veneers is the same as the Primary Predicate, K201668. The manufacture of the removable dentures is the same as the Secondary Predicate, K151142. The manufacture of artificial teeth is Class II, but 510(k)-exempt (product code ELM), therefore no Predicate is necessary.
While the E-Dent 1000 resin is different from Primary Predicate resin, each is a photo-
6
curable resin used in additive manufacturing of dental restorative devices and are of the same material category.
The Reference device, K102776, is presented because of similar technological characteristics to E-Dent 1000; it also is a photo-curable resin and the 3D printer and associated software are the same as used for E-Dent 1000.
The additive manufacturing processes for Primary Predicate and Reference devices use a photo-curable resin, scanner, 3D printer, curing unit and associated validated software.
The noted differences, in comparison to the Predicate devices, 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-Dent 1000 substantially equivalent to the Predicate devices. EnvisionTEC's analysis of E-Dent 1000 shows it has the same intended use, and technological parameters that meet the requirements of ISO 20795-1:2009-02.