(4 days)
No
The summary describes a 3D printable resin material and its use in a standard CAD/CAM workflow for dental restorations. There is no mention of AI or ML being used in the design, manufacturing, or evaluation process.
Yes
The device is used for fabricating permanent dental restorations such as inlays, onlays, veneers, and full crown restorations, which are used to treat or restore dental conditions.
No
The device is described as a material (methacrylate-based resin) used for fabricating permanent dental restorations like crowns, inlays, onlays, and veneers. Its purpose is to create physical dental prosthetics, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a light-cured, methacrylate-based resin used in 3D printers for the production of physical dental restorations. This is a 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 fabricating permanent dental restorations (inlays, onlays, veneers, crowns). This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The device is a material used in a 3D printing process to create physical dental prosthetics. It is not used to test or analyze samples from the human body to provide diagnostic information.
- Performance Studies: The performance studies focus on the physical properties of the material (flexural strength, water absorption, water solubility) and biocompatibility, which are relevant to the structural integrity and safety of a dental restoration, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such a function.
N/A
Intended Use / Indications for Use
VarseoSmile Crown plus is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The VarseoSmile Crown plus material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
VarseoSmile Crown plus is a light-cured, methacrylate-based resin used in 3D printers for the production of permanent crowns, inlays, onlays and veneers.
The Subject device is used by a dentist or dental technician for the CAD/CAM manufacturing of permanent dental restorations such as inlays, onlays, veneers and full crown prosthetics in compatible 3Dprinters. Restorations fabricated using the Subject device are one-time use, permanent, prescription-only devices. VarseoSmile Crown plus is suitable for restoration of occlusal surfaces. VarseoSmile Crown plus is cured externally to the patient by light sources within a 3D printer and post-curing device.
The Subject device is a viscous solution consisting of methacrylate-based resins, dental glass filler, photo initiators and pigments.
Commonly used dental CAD software is used by dental professionals to virtually design a fixed indirect restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The Subject resin is used within a validated manufacturing workflow to create the intended restoration. The Subject device is available in a variety of optional shades to reproduce the intended tooth shade of the restoration. Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical and biocompatible properties.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior and posterior restorations, including occlusal surfaces (teeth).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist or dental technician for the CAD/CAM manufacturing of permanent dental restorations.
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:
Validation of the manufacturing process was performed demonstrating consistency of the process output with that of the process input.
Physical property testing was performed on the Subject device to ISO 4049:2009, Dentistry — Polymer-based restorative materials and ISO 10477:2018, Dentistry – Polymer-based crown and veneering materials. Results demonstrated the Subject device meets the property requirements of the referenced standards.
The Subject device was evaluated for biocompatibility by way of the BEGO (K193533) Reference device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength ISO 4049 ≥100 MPa; ISO 10477 ≥50 MPa: > 100 MPa
Water Absorption ISO 4049 ≤40 µg/mm3; ISO 10477 ≤40 µg/mm3:
§ 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 contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 23, 2020
BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K201668
Trade/Device Name: VarseoSmile Crown Plus Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF Dated: June 18, 2020 Received: June 19, 2020
Dear Prithul Bom:
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.
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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 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.
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
VarseoSmile Crown plus
Indications for Use (Describe)
VarseoSmile Crown (00 is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The VarseoSmile Crown Rds material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K201668 510(k) Summary BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG VarseoSmile Crown ₪us 5/29/2020
ADMINISTRATIVE INFORMATION
| Manufacturer Name | BEGO Bremer Goldschlägerei
Wilh. Herbst GmbH & Co. KG
Wilhelm-Herbst-Straße 1
28359 Bremen, Germany
Telephone: +49 421-2028-394 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact
Email | Dr. Tanja Goetz - Regulatory Affairs Specialist
regulatoryaffairsdental@bego.com |
| Representative/Consultant | Chris Brown, BSEE |
Chris Br Aclivi, LLC 6455 Farley Road Pinckney, Michigan 48169 Telephone: +1 (810) 360-9773 E-mail: acliviconsulting@gmail.com
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | VarseoSmile Crown plus |
|---|---|
| Common Name: | Tooth shade resin material |
| Regulation Name: | Material, Tooth Shade, Resin |
| Regulation Number: | 21 CFR 872.3690 |
| Device Class: | Class II |
| Product Code: | EBF |
| Review Panel: | Dental |
| Reviewing Branch: | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1) |
| Dental Devices (DHT1B) |
PREDICATE DEVICE INFORMATION
The Subject device in this submission is substantially equivalent in indications, use and design principles to the following Predicate device.
| 510(k) | Predicate Device Name | Company Name | |
|---|---|---|---|
| K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | |
| 510(k) | Reference Device Name | Company Name | |
| K143033 | Dentca Denture Base | Denterprise International, Inc. | |
| K992645 | Sinfony | ESPE Dental AG (3M) | |
| K193553 | VarseoSmile Temp | BEGO Bremer Goldschlägerei |
INDICATIONS FOR USE
VarseoSmile Crown ®45 is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The VarseoSmile Crown Plus material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations.
4
DEVICE DESCRIPTION
VarseoSmile Crown plus is a light-cured, methacrylate-based resin used in 3D printers for the production of permanent crowns, inlays, onlays and veneers.
The Subject device is used by a dentist or dental technician for the CAD/CAM manufacturing of permanent dental restorations such as inlays, onlays, veneers and full crown prosthetics in compatible 3Dprinters. Restorations fabricated using the Subject device are one-time use, permanent, prescription-only devices. VarseoSmile Crown ₪6 is suitable for restoration of occlusal surfaces. VarseoSmile Crown ₪6 is cured externally to the patient by light sources within a 3D printer and post-curing device.
The Subject device is a viscous solution consisting of methacrylate-based resins, dental glass filler, photo initiators and pigments.
Commonly used dental CAD software is used by dental professionals to virtually design a fixed indirect restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The Subject resin is used within a validated manufacturing workflow to create the intended restoration. The Subject device is available in a variety of optional shades to reproduce the intended tooth shade of the restoration. Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical and biocompatible properties.
EQUIVALENCE TO MARKETED DEVICE
The Subject device is highly similar to the Primary Predicate device with respect to Indications for Use and technological principles. The comparison table below compare the Indications for Use and Technological Characteristics of the Subject and Predicate devices.
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Substantial Equivalence Comparison Table
| Parameter | Subject Device | Predicate Device | Reference Device | Reference Device | Reference Device | Substantial
Equivalence with
Predicate Device |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| | VarseoSmile Crownplus
BEGO Bremer Goldschlägerei | CAD/CAMouflage Milling Block
(K162537)
Prismatik Dentalcraft, Inc. | Dentca Denture Base (K143033)
Dentca, Inc. | Sinfony (K992645)
ESPE Dental AG (3M) | VarseoSmile Temp
(K193553)
BEGO Bremer Goldschlägerei | |
| Product Code | EBF | EBF | EBI | EBF | EBG | Substantially Equiv. |
| Regulation Number | 872.3690 | 872.3690 | 872.3760 | 872.3690 | 872.3770 | Substantially Equiv. |
| Regulatory Class | Class II | Class II | Class II | Class II | Class II | Substantially Equiv. |
| Indication for Use | VarseoSmile Crownplus is
indicated as an indirect
restorative for both anterior
and posterior restorations,
including occlusal surfaces.
The VarseoSmile Crownplus
material is used for
fabricating permanent
restorations such as inlays,
onlays, veneers and full
crown restorations. | CAD/CAMouflage Milling Block
is indicated as an indirect
restorative for both anterior
and posterior restorations,
including occlusal
surfaces. The
CAD/CAMouflage Milling Block
is made for fabricating
temporary and permanent
restorations such as inlays,
onlays, veneers and full crown
restorations. | Dentca Denture Base is a light-cured
resin indicated for fabrication and
repair of full and partial removable
dentures and baseplates. The material
is an alternative to traditional heat
cured and auto polymerizing resins.
Fabrication of dental prosthetics with
Dentca Denture Base requires a
computer-aided design and
manufacturing (CAD/CAM) system that
includes the following components not
part of the device: oral casting
impression, digital denture base file
created in an optical impression system,
stereolithographic additive printer, and | Full veneering of crowns and
bridges
Complete crowns
Inlays/onlays
Fiber reinforced crowns and
bridges
Direct bonded bridges
Telescopic and conical crowns
Attachments and implant works
Veneers
Long term temporary restorations
and their characterization
Customization of acrylic and
ceramic artificial teeth
Extraoral repairs | VarseoSmile Temp resin is
indicated for
The fabrication of
temporary dental
restorations in conjunction
with extraoral light-curing
equipment. | Very Similar
(see below) |
| | | | curing light equipment. | | | |
| Technology | 3D liquid (light-cured) print
resin for dental CAD/CAM | Resin blank for dental
CAD/CAM | 3D liquid (light-cured) print resin for
dental CAD/CAM | Two-part, light- cured resin. | 3D liquid (light-cured)
print resin for dental
CAD/CAM | Very Similar
(see below) |
| Material | Methacrylate polymer resin
(dimethacrylate) | Polymer resin | Methacrylate polymer resin
(dimethacrylate) | Methacrylate polymer resin
(dimethacrylate) | Methacrylate polymer
resin
(dimethacrylate) | Very Similar
(see below) |
| Material Shades | Common VITA-shades | Common VITA-shades | Pink | Common VITA- shades | Common VITA-shades | Substantially Equiv. |
| Biocompatible | Yes | Yes | Yes | Yes | Yes | Substantially Equiv. |
| OTC or Rx | Rx | Rx | Rx | Rx | Rx | Substantially Equiv. |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Non-Sterile | Non-sterile | Substantially Equiv. |
| | | | Chemical Composition | | | |
| Chemical
Composition | Methacrylate polymer resin
with photo initiator, inhibitor
and pigments | Polymer resin with fillers and
pigments | Methacrylate polymer resin with
photo initiator, inhibitor and
pigments | Methacrylate polymer resin with
photo initiator, inhibitor and
pigments | Methacrylate polymer
resin with photo initiator,
inhibitor and pigments | Very Similar
(see below) |
| | | | Non-Clinical Performance Test Data | | | |
| Performance Testing | ISO 4049
ISO 10477 | ISO 4049
ISO 10477 | ISO 20795-1 | Unknown | ISO 4049
ISO 10477 | Substantially Equiv. |
| Flexural Strength
ISO 4049 ≥100 MPa
ISO 10477 ≥50 MPa | > 100 MPa | > 100 MPa | 90.2 MPa | Unknown | > 100 MPa | Substantially Equiv. |
| Water Absorption
ISO 4049 ≤40 µg/mm3
ISO 10477 ≤40 µg/mm3 |