The provided submission describes FotoDent® denture, a light-curing resin for 3D printing of full and partial dentures. This is a Class II device (21 CFR 872.3760).

1. Acceptance Criteria and Reported Device Performance

The device was tested against the applicable requirements of ISO 20795-1:2013 (Dentistry – Base polymers – Part 1: Denture base polymers) and ISO 7491:2000 (Dentistry – Dental materials – Determination of colour stability). The submission states that FotoDent® denture "met the applicable requirements" of these standards.

A direct comparison of physical properties between FotoDent® denture and the predicate device (DENTCA Denture Base II) is provided, which implicitly sets the acceptance criteria based on demonstrating "similar physical properties" to the predicate.

Attribute	Acceptance Criteria (Predicate)	FotoDent® denture Performance (Reported)
Indications
Manufacturing of full dentures	Yes	Yes
Manufacturing of partial dentures	Yes	Yes
Physical Property
Type 4 (light-activated) acrylic resin	Yes (per ISO 20795-1)	Yes (per ISO 20795-1)
Before Curing (liquid state)
Viscosity	1000 < X < 2000 cps	400 < X < 600 cps
Density	1.05 < X < 1.2 g/cm³	1.05 – 1.15 g/cm³
After Curing (solid state)
Density	1.15 < X < 1.25 g/cm³	1.05 – 1.15 g/cm³
Flexural Strength	> 65 MPa	> 80 MPa
Flexural Modulus	> 2000 MPa	> 2000 MPa
Material Type	Resin based	Resin based
Chemical Characterization	Methacrylate/acrylate resins with photo-initiators, pigments and additives	Methacrylate/acrylate resins with photo-initiators, pigments and additives
Shelf Life	2 years	2 years
Storage	15-25°C, Do not expose to direct sunlight	18-28°C, Do not expose to direct sunlight
Physical Configuration	Supplied in liquid form	Supplied in liquid form
Shades	4 shades of pink	2 shades of pink
Application	3D Printing	3D Printing
Fabrication Type	Automated 3D printing of resin in multiple layers, each layer light-cured before adding next layer	Automated 3D printing of resin in multiple layers, each layer light-cured before adding next layer
Polymerization (Curing Method)	Light-curing resin	Light-curing resin
Post Curing	light-curing unit	light-curing unit
Teeth Assembly	Bonding	Bonding
Sterile	No	No
Single Use	No	No
Environment of Use	Dental Laboratory	Dental Laboratory

Note: The submission clarifies that "The differences in physical properties between FotoDent denture and the predicate device does not impact safety and effectiveness, as the finished clinical product is a custom-fitted denture base regardless of the material variation." This indicates that while some properties differ, they are deemed within an acceptable range for the intended use and do not negatively affect clinical outcomes compared to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The submission mentions "Bench test results" and "Non-Clinical Performance Testing" and "Biocompatibility" testing.

Sample Size: The document does not specify the sample sizes used for these tests.
Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. Given these are bench tests and biocompatibility evaluations, they are inherently prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The tests performed are non-clinical (bench tests and biocompatibility), and therefore do not involve human expert ground truth establishment in the way clinical studies with image interpretation or diagnosis would.

4. Adjudication Method for the Test Set

Not applicable. As described above, the tests are non-clinical, and thus an adjudication method for human interpretation is irrelevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states under "Clinical Performance Data": "Not applicable. No human clinical testing was performed to support the substantial equivalence of FotoDent® denture."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. FotoDent® denture is a physical material (resin) for 3D printing, not an algorithm or a software device that would have standalone performance.

7. The Type of Ground Truth Used

For the non-clinical performance and biocompatibility testing, the "ground truth" is established by the specifications and standard methodologies outlined in the referenced ISO standards (ISO 20795-1:2013, ISO 7491:2000, ISO 10993-1:2009, ISO 7405:2008). These standards define the acceptable range or characteristics for the material properties.

8. The Sample Size for the Training Set

Not applicable. As FotoDent® denture is a physical material, there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable, for the same reason as point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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 acronym along with the full name of the agency on the right. The FDA acronym is in blue, and the full name of the agency, "U.S. Food & Drug Administration," is in a smaller font size below the acronym.

November 19, 2020

Dreve Dentamid GmbH % Nevine Erian Regulatory Consultant BOC Consulting LLC 24341 Barbados Dr. Dana Point, California 92629

Re: K200580

Trade/Device Name: FotoDent denture Regulation Number: 21 CFR 872.3760 Regulation Name: Denture relining, repairing, or rebasing resin Regulatory Class: Class II Product Code: EBI Dated: November 10, 2020 Received: November 17, 2020

Dear Nevine Erian:

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 medical devices and radiation-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) K200580

Device Name

FotoDent® denture

Indications for Use (Describe)

FotoDent® denture is a light curing resin intended for manufacturing of full and partial removable 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)

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."

FORM FDA 3881 (7/17)

Page 1 of 1

{3}------------------------------------------------

K200580 510(k) Summary

Submitter	Dreve Dentamid GmbHMax-Planck-Strasse 3159423 Unna, Nordrhein-Westfalen, GermanyEstablishment Reg. No. 1000486347
Contact	Dr. Reiner AltmannHead of Quality Management & Regulatory AffairsPhone +49 2303 8807 14Fax +49 2303 8807 581E-Mail reiner.altmann@dreve.de
Official Correspondent	Nevine ErianRegulatory ConsultantBQC Consulting LLC24341 Barbados Dr.Dana Point, CA 92629Phone (949) 370-7155Fax (949) 240-8829E-mail nevine@bqcconsulting.com
Date Prepared	March 25, 2020

Trade/Device Name FotoDent® denture
Common Name Denture Material
Classification Name Resin, Denture, Relining, Repairing, Rebasing
Regulation Number 21 CFR 872.3760
Product Code EBI

Predicate Devices

DENTCA Denture Base II (DENTCA, Inc.) – K162044 – Primary Predicate

{4}------------------------------------------------

Device Description

FotoDent® denture is a light curable resin for 3D printing of full and partial dentures.

Statement of Intended Use

FotoDent® denture is a methacrylate-based material for denture fabrication.

Statement of Indication for Use

FotoDent® denture is a light curing resin intended for manufacturing of full and partial removable dentures.

Material Composition

FotoDent® denture is a methacrylate-based resin.

Technological Characteristics

FotoDent® denture is a light-curing resin for 3D printing.

Non-Clinical Performance Testing

FotoDent® denture was tested and met the applicable requirements of the following FDA Recognized Consensus standard:

I ISO 20795-1:2013 – Dentistry – Base polymers – Part 1: Denture base polymers
트 ISO 7491:2000 – Dentistry – Dental materials – Determination of colour stability

Bench test results allowed us to conclude that FotoDent® denture meets its intended use.

Biocompatibility

FotoDent® denture meets the biocompatibility requirements of the following standards:

I ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
. ISO 7405:2008 Dentistry - Evaluation of Biocompatibility of Medical Devices Used in Dentistry

Clinical Performance Data

Not applicable. No human clinical testing was performed to support the substantial equivalence of FotoDent® denture.

{5}------------------------------------------------

Substantial Equivalence

The technical characteristics of FotoDent® denture is substantially equivalent to the predicate device.

Material

FotoDent® denture is a resin-based material as the predicate device.

Physical Properties

FotoDent® denture has similar physical properties as the predicate devices.

Technical Comparison of FotoDent® denture to Predicate Devices

Attribute	FotoDent® denture	DENTCA Denture Base II
Indications
Manufacturing of full dentures	Yes	Yes
Manufacturing of partialdentures	Yes	Yes
Physical Property
Type 4 (light-activated)acrylic resin per ISO 20795-1	Yes	Yes
Before Curing (liquid state)
Viscosity	400 < X < 600 cps	1000 < X <2000 cps
Density	1.05 – 1.15 g/cm³	1.05 < X <1.2 g/cm3
After Curing (solid state)
Density	1.05 – 1.15 g/cm³	1.15 < X <1.25 g/cm3
Flexural Strength	>80 MPa	>65 MPa
Flexural Modulus	>2000 MPa	>2000 MPa
Material Type	Resin based	Resin based
Technical Attributes

{6}------------------------------------------------

Attribute	FotoDent® denture	DENTCA Denture Base II
Chemical Characterization	Methacrylate/acrylateresins with photo-initiators, pigments andadditives	Methacrylate/acrylateresins with photo-initiators,pigments and additives
Shelf Life	2 years	2 years
Storage	18 - 28°CDo not expose to directsunlight	15-25°CDo not expose to directsunlight
Physical Configuration	Supplied in liquid form	Supplied in liquid form
Shades	2 shades of pink	4 shades of pink
Application	3D Printing	3D Printing
Fabrication Type	Automated 3D printing ofresin in multiple layers,each layer light-curedbefore adding next layer	Automated 3D printing ofresin in multiple layers,each layer light-curedbefore adding next layer
Polymerization (CuringMethod)	Light-curing resin	Light-curing resin
Post Curing	light-curing unit	light-curing unit
Teeth Assembly	Bonding	Bonding
Sterile	No	No
Single Use	No	No
Environment of Use	Dental Laboratory	Dental Laboratory

The differences in physical properties between FotoDent denture and the predicate device does not impact safety and effectiveness, as the finished clinical product is a custom-fitted denture base regardless of the material variation.

Conclusion

Information provided in this application demonstrates that FotoDent® denture is substantially equivalent to the predicate device. FotoDent® denture has same indications for use, similar material composition, similar physical properties and technological characteristics as the DENTCA Denture Base II products.

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.