(425 days)
The C&B Ceramic material is used for fabrications such as inlays, onlays, onlays, veneers and full crown restorations.
The C&B Permanent material is used for fabrications such as inlays, onlays, onlays, veneers and full crown restorations
C&B Interim material is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral lightcuring equipment.
Prevest C&B, Ceramic Resin is a light-curing material with ceramic fillers used for the 3D printing/ fabrication of Ceramic Crown & Bridge dental prosthesis for use in DLP, LCD/MSLA 3D printers. It is reactive to wavelength of light between 385nm and 405nm. Recommended printers and light curing unit are Asiga Max UV, Ackuretta SOL and Acuretta Curie. It is stored in 500 and 1000ml HDPE bottles and is available in several shades: A1 /A2 /A3 /A3.5 /B1 /B2 /B3 /C2 /D3 /Bleach/Extra Bleach based on the shade guide.
Prevest C&B, Interim resin is a light-curing material with glass fillers used for the 3D printing/ fabrication of long term temporary Crown & Bridge dental prosthesis for use in DLP, LCD/MSLA 3D printers. It is reactive to wavelength of light between 385nm and 405nm. Recommended printers and light curing unit are Asiga Max UV, Ackuretta SOL and Acuretta Curie. It is stored in 500 and 1000ml HDPE bottles and is available in several Shades: A1 /A2 /A3 /A3.5 /B1 /B2 /B3/ C2 /D3/Bleach/Extra Bleach based on the shade guide.
Prevest C&B, Permanent resin is a light-curing material with glass fillers for the 3D printing/fabrication of Permanent crown and bride dental prosthesis for use in DLP, LCD/MSLA 3D printers. It is reactive to wavelength of light between 385nm and 405nm. Recommended printers and light curing unit are Asiga Max UV, Ackuretta SOL and Acuretta Curie. It is stored in 500 and 1000ml HDPE bottles and is available in several Shades: A1 / A2 / A3 / A3.5 / B1 / B2 / B3 / C2 / D3/Bleach/Extra Bleach based on the shade guide.
These materials are used for the additive manufacturing of crown and bridge prosthesis following the workflow as depicted below:
The provided text describes a 510(k) premarket notification for three dental resin materials: C&B Ceramic, C&B Permanent, and C&B Interim. The document states that these devices are substantially equivalent to predicate devices based on various testing results.
Here's the breakdown of the acceptance criteria and the study information as requested:
1. Table of Acceptance Criteria and Reported Device Performance:
The document directly compares the subject devices (C&B Ceramic, C&B Permanent, C&B Interim) with predicate/reference devices against established ISO standards for certain physical parameters.
| Performance Metric | Acceptance Criteria (from ISO Standard) | C&B Ceramic Performance | C&B Permanent Performance | C&B Interim Performance |
|---|---|---|---|---|
| Flexural Strength | ISO 4049 ≥ 100 MPa ISO 10477 ≥ 50 MPa | > 100 MPa | > 100 MPa | > 100 MPa |
| Water Sorption | ISO 4049 ≤ 40 µg/mm³ ISO 10477 ≤ 40 µg/mm³ | < 40 µg/mm³ | < 40 µg/mm³ | < 40 µg/mm³ |
| Water Solubility | ISO 4049 ≤ 7.5 µg/mm³ ISO 10477 ≤ 7.5 µg/mm³ | < 7.5 µg/mm³ | < 7.5 µg/mm³ | < 7.5 µg/mm³ |
Note: The document also mentions testing for "appearance, sensitivity to ambient light, color stability, shade stability," and "biocompatibility assessment according to ISO 10993-1," but does not provide specific numerical acceptance criteria or performance results for these tests beyond stating "All test results met the criteria in standard."
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "All test results met the criteria in standard" after testing protocols based on ISO 4049 and ISO 10477. These standards would typically define the required sample sizes for testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The tests performed are physical and chemical property tests against ISO standards, not evaluations that require human expert judgment for "ground truth" in the typical sense of clinical or diagnostic studies.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
An adjudication method is not applicable or mentioned in this context. The testing involves laboratory measurements of material properties against predefined international standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not performed or mentioned. This type of study is relevant for diagnostic medical devices where multiple human readers interpret cases with and without AI assistance. The devices described are dental resin materials, not diagnostic imaging or AI devices.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
A standalone performance study is not applicable as these are physical materials, not algorithms. The "testing summary" describes the evaluation of the materials' physical and chemical properties.
7. Type of Ground Truth Used:
The ground truth used for performance evaluation is based on established international standards (ISO 4049 and ISO 10477) for physical and chemical properties of dental restorative materials. These standards define the acceptable ranges for metrics like flexural strength, water sorption, and water solubility. Additionally, a biocompatibility assessment according to ISO 10993-1 was conducted.
8. Sample Size for the Training Set:
The concept of a "training set" is not applicable to this submission. These are physical materials, not machine learning algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for these physical materials, this question is not applicable.
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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.
November 27, 2024
Prevest Denpro Limited % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172
Re: K233273
Trade/Device Name: C&B Ceramic; C&B Permanent; C&B Interim Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, EBG Dated: March 5, 2024 Received: March 6, 2024
Dear Angela Blackwell:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-comprehensive-regulatory
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assistance/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,
MICHAEL E. ADJODHA -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
C& B Ceramic, C&B Permanent, C&B Interim
Indications for Use (Describe)
The C&B Ceramic material is used for fabrications such as inlays, onlays, onlays, veneers and full crown restorations.
The C&B Permanent material is used for fabrications such as inlays, onlays, onlays, veneers and full crown restorations
C&B Interim material is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral lightcuring equipment.
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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C & B Ceramic, C&B Interim, C&B Permanent 510(k) Summary - K233273 November 25, 2024
Name and Address: Prevest Denpro Limited Unit II, Export Promotion Industrial Park Bari Brahmana, Jammu 181133 India Contact Person: Atul Modi Email: prevestindia@gmail.com Telephone: (941) 919 4280
Name of device: C&B Ceramic, C&B Interim, C&B Permanent Classification Name: Tooth shade resin material CFR: 21 CFR 872.3690 Primary Product Code: EBF Secondary Product Code: EBG Regulatory Class: II
Submission Contact:
Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 (704)450-9934 angela@blackwelldevice.com
Device Description:
Prevest C&B, Ceramic Resin is a light-curing material with ceramic fillers used for the 3D printing/ fabrication of Ceramic Crown & Bridge dental prosthesis for use in DLP, LCD/MSLA 3D printers. It is reactive to wavelength of light between 385nm and 405nm. Recommended printers and light curing unit are Asiga Max UV, Ackuretta SOL and Acuretta Curie. It is stored in 500 and 1000ml HDPE bottles and is available in several shades: A1 /A2 /A3 /A3.5 /B1 /B2 /B3 /C2 /D3 /Bleach/Extra Bleach based on the shade guide.
Prevest C&B, Interim resin is a light-curing material with glass fillers used for the 3D printing/ fabrication of long term temporary Crown & Bridge dental prosthesis for use in DLP, LCD/MSLA 3D printers. It is reactive to wavelength of light between 385nm and 405nm. Recommended printers and light curing unit are Asiga Max UV, Ackuretta SOL and Acuretta Curie. It is stored in 500 and 1000ml HDPE bottles and is available in several Shades: A1 /A2 /A3 /A3.5 /B1 /B2 /B3/ C2 /D3/Bleach/Extra Bleach based on the shade guide.
Prevest C&B, Permanent resin is a light-curing material with glass fillers for the 3D printing/fabrication of Permanent crown and bride dental prosthesis for use in DLP, LCD/MSLA 3D printers. It is reactive to wavelength of light between 385nm and 405nm. Recommended printers and
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light curing unit are Asiga Max UV, Ackuretta SOL and Acuretta Curie. It is stored in 500 and 1000ml HDPE bottles and is available in several Shades: A1 / A2 / A3 / A3.5 / B1 / B2 / B3 / C2 / D3/Bleach/Extra Bleach based on the shade guide.
These materials are used for the additive manufacturing of crown and bridge prosthesis following the workflow as depicted below:
Image /page/5/Figure/2 description: The image shows a flowchart of the steps involved in 3D printing. The first step is to import the .STL file, followed by generating supports. The next steps are filling resin in the printer, printing the .STL file, and separating printed parts and supports. The final steps are cleaning and post-processing.
Indications for Use:
C&B Ceramic material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations.
C&B Permanent material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations.
C&B Interim material is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral light-curing equipment.
Testing Summary:
C&B Ceramic, C&B Interim, and C&B Permanent were tested for appearance, flexural strength, sensitivity to ambient light, water solubility, color stability, shade stability, according to protocols based on ISO 4049 and ISO 10477.
All test results met the criteria in standard.
Shelf life for C&B Ceramic, C&B Interim, and C&B Permanent is 3 years. All shelf life determinations use the same testing protocols as the characterization testing which are based on ISO 4049 and ISO 10477. The predicate and reference devices use the same ISO standard for their shelf lives are 2 years, 2,5 years or are not given.
A biocompatibility assessment according to ISO 10993-1 was conducted on all three resins.
Mechanism of Action: 3D printing of dental prosthesis
Type of Printer to Use with the materials: DLP, LCD/MSLA 3D printer with a light spectrum of between 385nm and 405nm like Ackuretta SOLand Asiga Max UV.
Predicate Device: Varseo Crown Plus K201668 and Varseo Smile Temp K193553 from Bego
Reference Devices: Freeprint Temp K200273 from Detax GmbH
Substantial Equivalence:
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The resins have similar ingredients to the predicate and reference devices, the same indications for use, and similar physical parameter testing.
| C&B Ceramic | C&BPermanent | Varseo Crown PlusK201668Predicate Device | Freeprint TempK200273Reference Device | |
|---|---|---|---|---|
| Product Code | EBF | EBF | EBF | EBG |
| Indications forUse | C&B Ceramicmaterial isused forfabricatingpermanentrestorationssuch as inlays,onlays,veneers andfull crownrestorations. | C&BPermanentmaterial isused forfabricatingpermanentrestorationssuch as inlays,onlays, veneersand full crownrestorations. | Varseo Crown Plusis indicated as anindirect restorativefor both anteriorand posteriorrestorations,including occlusalsurfaces. TheVarseoSmile CrownPlus material isused for fabricatingpermanentrestorations suchas inlays, onlays,veneers and fullcrown restorations. | Freeprint Temp isindicated for thefabrication oftemporary dentalrestorations inconjunction withextra-oral curinglight equipment.Duration is less than30 days in oralenvironment. |
| ApplicableStandards | ISO 4049ISO 10477 | ISO 4049ISO 10477 | ISO 4049ISO 10477 | ISO 10477 |
| Mechanism ofAction | 3D printing ofdentalprosthesis | 3D printing ofdentalprosthesis | 3D printing ofdental prosthesis | 3D printing of dentalprosthesis |
| Composition | Methacrylatepolymerresin withphotoinitiator,inhibitor, UVabsorber andpigments | Methacrylatepolymer resinwith photoinitiator,inhibitor, UVabsorber andpigments | Methacrylatepolymer resinwith photoinitiator, inhibitorand pigments | Polymer resin withphoto initiator, UVabsorber andpigments |
| FlexuralStrengthISO 4049 ≥100MpaISO 10477 ≥50MPa | >100 MPa | >100 MPa | >100 MPa | >100 MPa |
| Water | <40 µg/mm³ | <40 µg/mm³ | <40 µg/mm³ | <40 µg/mm³ |
| ISO 4049 ≤ 40 µg/mm³ISO 10477 ≤ 40 µg/mm³ | ||||
| Water SolubilityISO 4049 ≤ 7.5 µg/mm³ISO 10477 ≤ 7.5 µg/mm³ | <7.5 µg/mm³ | <7.5 µg/mm³ | <7.5 µg/mm³ | |
| Shelf Life | 3 years | 3 years | On label only | 2 years |
Crown and Bridge Resins for 3D Printing from Prevest Denpro
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| C&B Interim | Freeprint TempK200273Reference Device | VarseoSmile TempK193553Predicate Device | |
|---|---|---|---|
| Product Code | EBG | EBG | EBG |
| Indications for Use | C&B Interimmaterial isindicated for thefabrication oftemporarydentalrestorations inconjunction withextra-oral light-curingequipment. | Freeprint Temp isindicated for thefabrication oftemporary dentalrestorations inconjunction withextra-oral curinglight equipment.Duration is less than30 days in oralenvironment. | Varseo Temp resinis indicated for thefabrication oftemporary dentalrestorations inconjunction withextra-oral light-curing equipment. |
| Composition | Polymer resinwith photoinitiator, UVabsorber, fillerand pigments | Polymer resin withphoto initiator, UVabsorber andpigments | Polymer resin,initiator andpigments |
| ApplicableStandards | ISO 4049ISO 10477 | ISO 10477 | ISO 4049ISO 10477 |
| Mechanism ofAction | 3D printing ofdental prosthesis | 3D printing of dentalprosthesis | 3D printing ofdental prosthesis |
| FlexuralStrength | >100 MPa | >100 MPa | >100 MPa |
| ISO 4049 ≥100MpaISO 10477 ≥50MPa | |||
| Water | <40 µg/mm³ | <40 µg/mm³ | <40 µg/mm³ |
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| ISO 4049 ≤ 40 µg/mm³ISO 10477 ≤ 40 µg/mm³ | |||
|---|---|---|---|
| Water SolubilityISO 4049 ≤ 7.5 µg/mm³ISO 10477 ≤ 7.5 µg/mm³ | <7.5 µg/mm³ | <7.5 µg/mm³ | <7.5 µg/mm³ |
| Shelf Life | 3 years | 2 years | On label only |
Conclusion: C&B Ceramic, C&B Permanent, and C&B Interim are substantially equivalent to the predicate devices. They have the same indications, similar testing, and very similar ingredients. Both the subject devices and the predicate device have physical parameters which meet requirements of the relevant ISO standards. Shelf life testing is similar to the shelf life testing of predicate or reference device. Reference devices are included to cover any ingredients not covered by the predicate devices. Any differences in ingredients are minor and do not change the substantial equivalence.
§ 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.