FotoDent denture

K200580 · Dreve Dentamid GmbH · EBI · Nov 19, 2020 · Dental

Device Facts

• Record ID: K200580
• Device Name: FotoDent denture
• Applicant: Dreve Dentamid GmbH
• Product Code: EBI · Dental
• Decision Date: Nov 19, 2020
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

FotoDent® denture is a methacrylate-based light-curing resin used for the 3D printing of full and partial removable dentures. The material is supplied in liquid form and processed in a dental laboratory setting. The fabrication process involves automated 3D printing where the resin is cured in multiple layers; each layer is light-cured before the subsequent layer is added. Following the printing process, the denture undergoes final light-curing in a light-curing unit. The resulting device is a custom-fitted denture base. The output is used by dental professionals to provide patients with removable prosthetic replacements for missing teeth, thereby restoring oral function and aesthetics.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including compliance with ISO 20795-1 (denture base polymers) and ISO 7491 (color stability), as well as biocompatibility testing per ISO 10993-1 and ISO 7405.

Technological Characteristics

Methacrylate-based resin with photo-initiators, pigments, and additives. Light-curing polymerization. Form factor: liquid for 3D printing. Complies with ISO 20795-1 (Type 4 light-activated acrylic resin) and ISO 7491. Biocompatibility per ISO 10993-1 and ISO 7405. Non-sterile.

Indications for Use

Indicated for the manufacturing of full and partial removable dentures in patients requiring dental prosthetics.

Regulatory Classification

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.

Predicate Devices

• DENTCA Denture Base II (K162044)

Submission Summary (Full Text)

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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

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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 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 ([e-mail]) or phone [phone] 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

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## 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)

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# K200580 510(k) Summary

| Submitter | Dreve Dentamid GmbH<br>Max-Planck-Strasse 31<br>59423 Unna, Nordrhein-Westfalen, Germany<br>Establishment Reg. No. 1000486347 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Dr. Reiner Altmann<br>Head of Quality Management & Regulatory Affairs<br>Phone [phone]<br>Fax [phone]<br>E-Mail [e-mail] |
| Official Correspondent | Nevine Erian<br>Regulatory Consultant<br>BQC Consulting LLC<br>24341 Barbados Dr.<br>Dana Point, CA 92629<br>Phone [phone]<br>Fax [phone]<br>E-mail [e-mail] |
| 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

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### 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.

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## 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 partial<br>dentures | Yes | Yes |
| Physical Property | | |
| Type 4 (light-activated)<br>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 | | |

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| Attribute | FotoDent® denture | DENTCA Denture Base II |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Chemical Characterization | Methacrylate/acrylate<br>resins with photo-<br>initiators, pigments and<br>additives | Methacrylate/acrylate<br>resins with photo-initiators,<br>pigments and additives |
| Shelf Life | 2 years | 2 years |
| Storage | 18 - 28°C<br>Do not expose to direct<br>sunlight | 15-25°C<br>Do not expose to direct<br>sunlight |
| 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 of<br>resin in multiple layers,<br>each layer light-cured<br>before adding next layer | Automated 3D printing of<br>resin in multiple layers,<br>each layer light-cured<br>before adding next layer |
| Polymerization (Curing<br>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 |

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.