(4 days)
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.
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 is suitable for restoration of occlusal surfaces. VarseoSmile Crown 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.
This document is for a dental material (VarseoSmile Crown Plus), not an AI/ML powered medical device. Therefore, a table of acceptance criteria and reported device performance for an AI/ML device, as well as the other requested information related to AI/ML device studies (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance), are not applicable to the provided text.
The information provided focuses on demonstrating substantial equivalence of the dental material to predicate devices based on indications for use, technological characteristics, and non-clinical performance testing against established ISO standards for dental materials.
Here's a breakdown of the relevant information from the document regarding the device's acceptance criteria and how it was shown to meet them:
Acceptance Criteria and Reported Device Performance (Non-AI/ML Device):
| Parameter | Acceptance Criteria (ISO Standard) | Reported Device Performance (VarseoSmile Crown Plus) |
|---|---|---|
| Flexural Strength | ISO 4049 ≥ 100 MPa | > 100 MPa |
| ISO 10477 ≥ 50 MPa | - | |
| Water Absorption | ISO 4049 ≤ 40 µg/mm³ | < 40 µg/mm³ |
| ISO 10477 ≤ 40 µg/mm³ | - | |
| Water Solubility | ISO 4049 ≤ 7.5 µg/mm³ | < 7.5 µg/mm³ |
| ISO 10477 ≤ 7.5 µg/mm³ | - | |
| Biocompatibility | Yes | Yes |
| Manufacturing Consistency | Consistent process output | Validation performed |
Study Information (Non-AI/ML Device):
- Sample size for test set and data provenance: Not applicable to this type of device and testing. The performance testing is on the material itself, not on a "test set" of patient data.
- Number of experts and qualifications for ground truth: Not applicable. Ground truth for material properties is established by international standards and laboratory testing, not expert consensus.
- Adjudication method for test set: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: International Standards (ISO 4049, ISO 10477) for physical properties, and biocompatibility testing criteria.
- Sample size for training set: Not applicable. This is not an AI/ML device that requires a training set.
- How ground truth for training set was established: Not applicable.
The document states that "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."
For biocompatibility, it states: "The Subject device was evaluated for biocompatibility by way of the BEGO (K193533) Reference device." This implies that the biocompatibility of the VarseoSmile Crown Plus was established by demonstrating its similarity to a previously cleared device (BEGO VarseoSmile Temp, K193533) which likely had its biocompatibility established. This is a common approach in 510(k) submissions for material equivalence.
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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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K201668 510(k) Summary BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG VarseoSmile Crown ₪us 5/29/2020
ADMINISTRATIVE INFORMATION
| Manufacturer Name | BEGO Bremer GoldschlägereiWilh. Herbst GmbH & Co. KGWilhelm-Herbst-Straße 128359 Bremen, GermanyTelephone: +49 421-2028-394 |
|---|---|
| Official ContactEmail | Dr. Tanja Goetz - Regulatory Affairs Specialistregulatoryaffairsdental@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.
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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 | SubstantialEquivalence withPredicate Device |
|---|---|---|---|---|---|---|
| VarseoSmile CrownplusBEGO 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 isindicated as an indirectrestorative for both anteriorand posterior restorations,including occlusal surfaces.The VarseoSmile Crownplusmaterial is used forfabricating permanentrestorations such as inlays,onlays, veneers and fullcrown restorations. | CAD/CAMouflage Milling Blockis indicated as an indirectrestorative for both anteriorand posterior restorations,including occlusalsurfaces. TheCAD/CAMouflage Milling Blockis made for fabricatingtemporary and permanentrestorations such as inlays,onlays, veneers and full crownrestorations. | Dentca Denture Base is a light-curedresin indicated for fabrication andrepair of full and partial removabledentures and baseplates. The materialis an alternative to traditional heatcured and auto polymerizing resins.Fabrication of dental prosthetics withDentca Denture Base requires acomputer-aided design andmanufacturing (CAD/CAM) system thatincludes the following components notpart of the device: oral castingimpression, digital denture base filecreated in an optical impression system,stereolithographic additive printer, and | Full veneering of crowns andbridgesComplete crownsInlays/onlaysFiber reinforced crowns andbridgesDirect bonded bridgesTelescopic and conical crownsAttachments and implant worksVeneersLong term temporary restorationsand their characterizationCustomization of acrylic andceramic artificial teethExtraoral repairs | VarseoSmile Temp resin isindicated forThe fabrication oftemporary dentalrestorations in conjunctionwith extraoral light-curingequipment. | Very Similar(see below) |
| curing light equipment. | ||||||
| Technology | 3D liquid (light-cured) printresin for dental CAD/CAM | Resin blank for dentalCAD/CAM | 3D liquid (light-cured) print resin fordental CAD/CAM | Two-part, light- cured resin. | 3D liquid (light-cured)print resin for dentalCAD/CAM | Very Similar(see below) |
| Material | Methacrylate polymer resin(dimethacrylate) | Polymer resin | Methacrylate polymer resin(dimethacrylate) | Methacrylate polymer resin(dimethacrylate) | Methacrylate polymerresin(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 | ||||||
| ChemicalComposition | Methacrylate polymer resinwith photo initiator, inhibitorand pigments | Polymer resin with fillers andpigments | Methacrylate polymer resin withphoto initiator, inhibitor andpigments | Methacrylate polymer resin withphoto initiator, inhibitor andpigments | Methacrylate polymerresin with photo initiator,inhibitor and pigments | Very Similar(see below) |
| Non-Clinical Performance Test Data | ||||||
| Performance Testing | ISO 4049ISO 10477 | ISO 4049ISO 10477 | ISO 20795-1 | Unknown | ISO 4049ISO 10477 | Substantially Equiv. |
| Flexural StrengthISO 4049 ≥100 MPaISO 10477 ≥50 MPa | > 100 MPa | > 100 MPa | 90.2 MPa | Unknown | > 100 MPa | Substantially Equiv. |
| Water AbsorptionISO 4049 ≤40 µg/mm3ISO 10477 ≤40 µg/mm3 | < 40 µg/mm3 | < 40 µg/mm3 | 14 µg/mm3 | Unknown | < 40 µg/mm3 | Substantially Equiv. |
| Water SolubilityISO 4049 ≤7.5 µg/mm3ISO 10477 ≤7.5 µg/mm3 | < 7.5 µg/mm3 | < 7.5 µg/mm3 | 1.3 µg/mm3 | Unknown | < 7.5 µg/mm3 | Substantially Equiv. |
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In the above table, Substantially Equiv. is used to represent Substantially Equivalent.
Product Code/Regulation/Regulatory Class - The Subject and Predicate devices are Substantially Equivalent. The Dentca (K143033) and BEGO (K193554) Reference devices has a different Product Code and Regulation number due to different indications. The Subject and Sinfony (K992645) Reference devices share the same Product Code and Regulation name.
Indications for Use - The Subject and Predicate are Very Similar, differing only by reference to the device name and the Predicate device is also indicated for temporary restorations. Like the Subject device, the Dentca (K143033) Reference device is also indicating permanent-use dental CAD/CAM restorative prosthetics. The Sinfony (K992645) Reference device shares common permanent restoration indications. The BEGO (K193553) Reference device is similar in that it is indicated for temporary dental restorations.
Technology - The Subject and Predicate devices are Very Similar in they are both resins for creations using CAD/CAM technology. The Predicate device (K162537) is offerent "working" form factor as it is a previously-cured resin and formed into a solid blank before use. The Predicate device is modified from a solid blank to final form (crown, inlay, veneer) through subtractive manufacturing CAD/CAM technology. The Subject device and Dentca (K143033) and BEGO (K193553) Reference devices use the same 3D printing CAD/CAM technology to cure the Subject device resin into final form demonstrating that additive manufacturing technology is viable for fabricating dental prosthetic devices. Differences between the Subject, Predicate and Sinfony Reference devices in the methods used to fabricate restorations (additive vs manual) do not change the intended use of the devices to create permanent dental restorations.
Material/Chemical Composition - The Subject and Predicate devices are Very Similar in they are both polymer resins. Slight differences in chemical composition do not change the intended use of the Subject, Predicate and Reference devices to be used in the fabrication of dental prostheses.
Material Shades - The Subject and Predicate devices are substantially equivalent.
The Subject, Predicate and Reference devices are all cured-resin materials indication and/or repair of dental prosthetic devices. The Subject, Predicate and BEGO Reference devices accomplish this by means of CAD/CAM technology. Minor differences in material properties or manufacturing process do not alter or impact the ability of the Subject device to be used for its intended use. In all cases, the Subject, Predicate and Reference devices have been demonstrated to be suitable for their intended use through non-clinical performance testing.
Overall, the Technological Characteristics of the Subject device and that of the Predicate and Reference devices support a finding of Substantial Equivalence.
CLINICAL TESTING
The performance of methacrylate-based polymer resins in the clinical environment has been well established. No clinical data is included in this submission.
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.
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CONCLUSION
Overall, the Subject device has the following similarities to the legally marketed Predicate device:
- Have nearly identical Indications for Use and Intended Use
- . Have very similar Technological Characteristics
- . Differences in Technological Characteristics with the Predicate device have been found to be substantially equivalent to the Technological Characteristics of the Reference devices.
- . Any differences have been mitigated by demonstration of the Subject device to be suitable for intended use through additional non-clinical performance testing.
This satisfies the requirements of Decisions 1-5b of the Appendix A. Decision-Making flowchart in the FDA Guidance Evaluating Substantial Equivalence in Premarket Notifications [510(k)].
Overall, the Subject and Predicate devices have been demonstrated to be Substantially Equivalent.
§ 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.