(259 days)
Not Found
No
The 510(k) summary describes a light-curing resin for 3D printing dentures and does not mention any AI or ML components or functionalities. The performance studies focus on material properties and biocompatibility, not algorithmic performance.
No
The device is a light-curing resin used for manufacturing dentures, which are prosthetic devices, not therapeutic devices. Therapeutic devices are typically used to treat or cure a disease or medical condition.
No
The device is a light-curing resin for manufacturing dentures, which is a restorative rather than a diagnostic function. The document also lacks any mention of diagnostic capabilities, imaging, or analysis of medical conditions.
No
The device description clearly states it is a "light curable resin for 3D printing," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for manufacturing of full and partial removable dentures. This is a device used in the mouth for a prosthetic purpose, not for testing samples outside the body to diagnose or monitor a medical condition.
- Device Description: The description confirms it's a light curable resin for 3D printing dentures.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes or biomarkers
- Use in a laboratory setting for diagnostic testing
The device is clearly intended for the fabrication of a medical device (dentures) that is placed in the patient's mouth. This falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
FotoDent® denture is a light curing resin intended for manufacturing of full and partial removable dentures.
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
FotoDent® denture is a light curable resin for 3D printing of full and partial dentures.
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
Dental Laboratory
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)
Non-Clinical Performance Testing: FotoDent® denture was tested and met the applicable requirements of the following FDA Recognized Consensus standard: ISO 20795-1:2013 – Dentistry – Base polymers – Part 1: Denture base polymers; 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: 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.
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.
Not Found
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
§ 872.3760 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.
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 GmbH
Max-Planck-Strasse 31
59423 Unna, Nordrhein-Westfalen, Germany
Establishment Reg. No. 1000486347 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Dr. Reiner Altmann
Head of Quality Management & Regulatory Affairs
Phone +49 2303 8807 14
Fax +49 2303 8807 581
E-Mail reiner.altmann@dreve.de |
| Official Correspondent | Nevine Erian
Regulatory Consultant
BQC Consulting LLC
24341 Barbados Dr.
Dana Point, CA 92629
Phone (949) 370-7155
Fax (949) 240-8829
E-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 partial | ||
| dentures | Yes | Yes |
| Physical Property | ||
| Type 4 (light-activated) | ||
| acrylic resin per ISO 20795-1 | Yes | Yes |
| Before Curing (liquid state) | ||
| Viscosity | 400 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/acrylate | |
| resins with photo- | ||
| initiators, pigments and | ||
| additives | Methacrylate/acrylate | |
| resins with photo-initiators, | ||
| pigments and additives | ||
| Shelf Life | 2 years | 2 years |
| Storage | 18 - 28°C | |
| Do not expose to direct | ||
| sunlight | 15-25°C | |
| Do not expose to direct | ||
| 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 | |
| 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 |
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.