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.

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

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental material (E-Dent 1000), not an AI/ML medical device. Therefore, a direct answer to the request regarding acceptance criteria and a study proving an AI/ML device meets them, including details like sample size for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, and training set details, cannot be extracted from the given document.

The document focuses on the substantial equivalence of the E-Dent 1000 resin to predicate dental materials based on physical and chemical properties, biocompatibility, and manufacturing processes, not on the performance of a software algorithm.

However, I can extract the relevant information about the non-AI device's performance testing and acceptance criteria as described in the document:

Here's the information about the E-Dent 1000 device's performance and acceptance criteria, adapted to the closest relevant sections of your request, noting where the information is not applicable to an AI/ML device:

1. A table of acceptance criteria and the reported device performance

The document states that testing was conducted to evaluate the performance of manufactured crowns, artificial teeth, veneers, and dentures according to specific ISO standards. The "acceptance criteria" are implied by compliance with these standards, and "reported device performance" is the statement that the device meets these requirements.

Performance Characteristic	Acceptance Criteria (Standard Compliance)	Reported Device Performance
Mechanical Properties	DIN EN ISO 10477:2018 (Polymer-based crown and veneering materials)	Samples were tested and meet the requirements.
	DIN EN ISO 4049:2019-09 (Polymer-based restorative materials)	Samples were tested and meet the requirements.
	DIN EN ISO 20795-1:2009-02 (Prosthetic resins)	Samples were tested and meet the requirements.
Flexural Strength	Implied by ISO standards above	Tested, results provided in 510(k).
Flexural Modulus	Implied by ISO standards above	Tested, results provided in 510(k).
Freedom from porosity	Implied by ISO standards above	Tested, results provided in 510(k).
Aesthetic Properties	DIN EN ISO 7491: (Color stability)	Tested, results provided in 510(k).
Color and Color Stability	Implied by ISO standards above	Tested, results provided in 510(k).
Translucency	Implied by ISO standards above	Tested, results provided in 510(k).
Physical Properties	Implied by ISO standards above	Tested, results provided in 510(k).
Surface Quality	Implied by ISO standards above	Tested, results provided in 510(k).
Dimensional Stability	Implied by ISO standards above	Tested, results provided in 510(k).
Water Sorption	Implied by ISO standards above	Tested, results provided in 510(k).
Water Solubility	Implied by ISO standards above	Tested, results provided in 510(k).
Biocompatibility	ISO 10993 series (specific tests listed below according to GLP)	Biocompatible and non-toxic, meets requirements for device in contact with mucosal membrane for >30 days.
Shelf Life	Real-time validation for 24 months at 30°C in original packaging	Accelerated shelf life of 4 months at time of 510(k) submission. Real-time testing ongoing.
Specific Shelf-Life Props.	Material viscosity, photoreactivity, color change, transport stability	Tested during shelf-life validation.
Additive Manufacturing	FDA guidance Technical Considerations for Additive Manufactured Medical Devices	Evaluation of all relevant properties of printed resin using permitted machines, incl. orientation. Results provided in 510(k).

2. Sample sized used for the test set and the data provenance

Sample Size: Not explicitly stated for each test, but implied by the successful completion of testing according to ISO standards. Sample sizes for material testing are standard for these types of evaluations.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is a material test, not a patient data study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: This is a material science and biocompatibility study, not a study involving expert-established ground truth from images or clinical data. The "ground truth" is defined by compliance with established international standards for dental materials.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: No human adjudication is involved in these laboratory material tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable: This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: This is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Type of Ground Truth: Established international standards for dental materials (e.g., ISO 10477, ISO 4049, ISO 7491, ISO 20795-1) for physical/mechanical properties, and ISO 10993 for biocompatibility.

8. The sample size for the training set

Not Applicable: There is no "training set" as this is not an AI/ML device. For material development, formulation and process optimization would occur, but these are not referred to as "training sets" in this context.

9. How the ground truth for the training set was established

Not Applicable: See point 8.

Summary

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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

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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

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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

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)

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510(k) Summary

I. SUBMITTER
Submitter Name:	EnvisionTEC GmbH
Submitter Address:	Bruesseler Straße 51D-45968 GladbeckGermany
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
ClassificationNumbers NamesProduct CodesDevice Class	21 CFR 872.3690Material, ToothShade, ResinEBFII	21 CFR 872.3760Resin, Denture,Relining, Repairing,RebasingEBIII	21 CFR 872.3590Denture, Plastic,TeethELMII, 510(k)-Exempt
III. PREDICATE DEVICE
Predicate Devices
Primary Predicate	K201668, VarseoSmile Crown Plus, BEGO Bremer GoldschlagereiWilh. Herbst GmbH & Co. KG (EBF product code)
SecondaryPredicate	K151142, IvoBase CAD for Zenotec, IvoBase CAD Bond andModelling Liquid, Ivoclar Vivadent, Inc. (EBI product code)
ReferenceDevice(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 frontand 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

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based on manufacturer's data, a digital light processing (DLP) printer, and curing lightequipment.
V. DEVICE DESCRIPTION
DeviceIdentification	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.
TechnologicalCharacteristics	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.
LaboratoryTesting:	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 attime of 510(k) submission is 4 months. The resin is on real-timevalidation testing for an ultimate shelf life of 24 months, stored inthe original packaging at temperatures at 30° C. Properties beingtested include material viscosity, material photoreactivity and colorchange. The E-Dent 1000 resin also was tested for good transportstability.
BiocompatibilityTesting:	A biocompatibility risk assessment was developed and presentedin the 510(k). As a result, the following ISO 10993 tests wereconducted according to Good Laboratory Practices.Testing showed the E-Dent 1000 printed and tested samples arebiocompatible and non-toxic and meet the requirements for adevice 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 – IntracutaneousInjection in Rabbits (Part 10) Acute Systemic Toxicity Study in Mice (Part 11)
AdditiveManufacturing	Testing, according to FDA's guidance Technical Considerations forAdditive Manufactured Medical Devices , was performed andresults were provided in the 510(k). These tests includedevaluation of all relevant properties of the printed resin using thepermitted machines. Further, tests based on considerations of theorientation during manufacturing were performed.

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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-

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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.

Regulation Number and Section

§ 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.