3M™ VitCal Liner/Base

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 6, 2023 3M ESPE Dental Products % Prithul Bom Most Responsible Personal Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 Re: K230270 Trade/Device Name: 3M™ VitCal Liner/Base Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium hydroxide cavity liner Regulatory Class: Class II Product Code: EJK Dated: January 31, 2023 Received: January 31, 2023 # 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. {1}------------------------------------------------ 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 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, # Michael E. Adjodha -S Michael E. Adjodha, M.ChE. 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 {2}------------------------------------------------ # Indications for Use Submission Number (if known) K230270 Device Name 3M TM VitCal Liner/Base Indications for Use (Describe) 3M VitCal Liner/Base is indicated for lining and basing applications under dental restorations. 3M VitCal Liner/Base is also indicated for direct pulp capping. 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) ### 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." 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The alphanumeric sequence appears to be a code or identifier, possibly a product or serial number. Image /page/3/Picture/1 description: The image contains the 3M logo. The logo is red and consists of the number 3 followed by the letter M. The logo is simple and recognizable. This 510(k) summary is submitted in accordance with the requirements of 21 CFR §807.92 # Submitter Information | 510(k) Submitter........................ | 3M ESPE Dental Products<br>2510 Conway Avenue<br>St. Paul, MN 55144, USA<br>Establishment Registration No.: 3005174370 | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | Primary Contact........................ | Chandrapaul(CP) Parsram, M.S.<br>Regulatory Affairs Associate<br>Phone: (651) 467 3014<br>cparsram@mmm.com | | Secondary Contact........................ | Suzanne Leung, Ph.D.<br>Regulatory Affairs Director<br>Phone: (651) 575 8052<br>sleung2@mmm.com | | Submission Date........................ | 27th January, 2023 | # Subject Device Information | Proprietary Trade Name........................ | 3M™ VitCal Liner/Base | |--------------------------------------------------------|---------------------------| | Device Name........................................ | Liner/Base | | Common Name..................................... | Liner/Base, Dental Cement | | Classification Name............................. | Dental Cement | | Regulation Number............................... | 21 CFR § 872.3275 | | Product Code........................................ | EMA | | Classification Panel.............................. | Dental Products | | Classification........................................ | Medical Device, Class II | # Predicate Devices: | Product Name | TheraCal LC® (Primary<br>Predicate) | 3M™ Vitrebond™ Plus<br>(Secondary Predicate) | |---------------|------------------------------------------------------------------|------------------------------------------------------------------------| | Manufacturer | Bisco, Inc.<br>1100 WEST IRVING PARK RD.<br>SCHAUMBURG, IL 60193 | 3M ESPE Dental Products<br>2510 Conway Avenue<br>Saint Paul, MN, 55144 | | 510(k) Number | K063237 | K011200 | | Device Class | 2 | 2 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the 3M logo. The logo consists of the number "3" and the letter "M" in a bold, red font. The logo is simple and recognizable, and it is often used on 3M products and marketing materials. # Description of Device 3M VitCal liner/base is a two-part paste/paste, light-cured system. The paste/paste materials are contained in a Micro-Mix Syringe Dispensing System. This dispensing system provides simultaneous dispensing and mixing of each component for a consistent mix and direct application into the mouth. The composition is a combination of a resin-modified glass ionomer and calcium-based material. The first paste contains a radiopaque fluoro-aluminosilicate glass and calcium filler. The second paste contains a modified polyalkenoic acid. VitCal liner/base provides the major benefits of glass ionomer cements including adhesion to the tooth structure and sustained fluoride release. Additionally, VitCal linerbase offers a high pH environment and a combination of a prolonged working time with an on-demand set time achieved by light curing. 3M VitCal Liner/Base meets the requirements for ISO 9917-2 Class 2 Liner/Base. # Indications for Use 3M VitCal Liner/Base is indicated for lining and basing applications under dental restorations. 3M VitCal Liner/Base is also indicated for direct pulp capping. # Substantial Equivalence Substantial equivalency of 3M VitCal LinersBase to TheraCal LC and 3M Vitrebond Plus is made on the basis of intended/indicated use, technological characteristics, and performance testing. Differences in technological characteristics of the subject device and the primary predicate devices have been evaluated in accordance with the Agency's Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] dated July 28, 2014. In accordance with this guidance document, a "different question of safety or effectiveness" means a question raised by the technological characteristics of the new device that was not applicate device and poses a significant safety or effectiveness concern for the new device. Differences in the technological characteristics of 3M VitCal, TheraCal LC, and 3M Vitrebond Plus do not rase different questions of safety or effectiveness. | Substantial Equivalence - Intended/Indicated Use | | | | | |---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | 3M VitCal Liner/Base<br>(Subject Device) | TheraCal LC<br>(Primary Predicate,<br>K063237) | 3M Vitrebond Plus<br>(Secondary Predicate,<br>K011200) | Comparison | | Product<br>Code | EMA - Cement, Dental | EJK - Liner, Cavity, Calcium<br>Hydroxide | EMA - Cement, Dental | The product code is the same<br>for 3M VitCal Liner/Base and<br>3M Vitrebond Plus. | | Regulation | 872.3275 - Dental cement | 872.3250 - Calcium hydroxide<br>cavity liner | 872.3275 - Dental cement | The regulation is the same for<br>3M VitCal Liner/Base and 3M<br>Vitrebond Plus. | | Intended<br>Use per<br>Regulation | 872.3275(b)(1) Dental cement other<br>than zinc oxide-eugenol is a device<br>composed of various materials other<br>than zinc oxide-eugenol<br>intended......to be applied to a<br>tooth to protect the tooth pulp. | 872.3250(a) A calcium hydroxide<br>cavity liner is a device material<br>intended to be applied to the<br>interior of a prepared cavity<br>before insertion of restorative<br>material, such as amalgam, to<br>protect the pulp of a tooth. | 872.3275(b)(1) Dental cement<br>other than zinc oxide-eugenol is<br>a device composed of various<br>materials other than zinc oxide-<br>eugenol intended......to be<br>applied to a tooth to protect the<br>tooth pulp. | Dental cements and calcium<br>hydroxide cavity liners are both<br>intended for use in dental<br>restorative procedures to<br>protect the pulp. | | Indications<br>for Use -<br>510(k) | Liner/base, Pulp capping | Liner, Pulp capping agent | Vitrebond Plus liner/base is<br>indicated for lining and basing<br>applications under the<br>following restorations:<br>Composite; Amalgam;<br>Ceramic; Metal | 3M VitCal Liner/Base and<br>TheraCal LC have the same<br>indications for use. Both<br>devices are indicated for use in<br>pulp capping and lining/basing<br>applications. Although not<br>explicitly stated in the 510(k)<br>clearance, TheraCal LC is<br>currently labeled for basing<br>applications.<br>All three devices are indicated<br>for use in liner/base<br>applications. | | Substantial Equivalence – Technological Characteristics | | | | | | Device | 3M VitCal<br>Liner/Base<br>(Subject Device) | TheraCal LC<br>(Primary Predicate,<br>K063237) | 3M Vitrebond Plus<br>(Secondary Predicate,<br>K011200) | Comparison | | Number of<br>Components | Two (paste/paste) | One | Two (paste/liquid) | 3M VitCal Liner/Base differs from TheraCal<br>LC but is similar to Vitrebond Plus. This<br>difference does not raise different questions<br>about safety or effectiveness as two-part<br>liner/base, and pulp capping materials are<br>common, established technology in dental<br>preparations, i.e., Vitrebond Plus. | | ISO 9917-2 Class | Class 2, Base or<br>Lining | Not applicable. | Class 2, Base or Lining | TheraCal LC does not claim compliance to<br>ISO 9917-2 Dentistry - Water-based cements<br>Part 2: Resin-modified cements. Both 3M<br>VitCal Liner/Base and Vitrebond Plus meet<br>the requirements for working time, flexural<br>strength, and radiopacity as ISO 9917-2 Class<br>2 Base/Liner materials. This difference does<br>not raise different questions of safety or<br>effectiveness. | | Working Time per<br>Annex A of ISO<br>9917-2 | ≥1.5 minutes | Not labeled | ≥1.5 minutes | VitCal Liner/Base and Vitrebond Plus meet<br>the requirements for working time, flexural<br>strength, and radiopacity as ISO 9917-2 Class | | Flexural Strength<br>per Annex C of ISO<br>9917-2 | ≥10 MPa | Not labeled | ≥10 MP | 2 Base/Liner materials. This difference does<br>not raise different questions of safety or<br>effectiveness. | | Radiopacity per<br>Annex D of 9917-2<br>and ISO 13116 | ≥1.0 mm<br>Aluminum<br>Standard (mmAl) | ≥1.0 mm Aluminum<br>Standard (mmAl) | ≥1.0 mm Aluminum<br>Standard (mmAl) | | | Setting Mechanism | Light cure | Light cure | Light cure | All devices are light-cured. | | Cure Time and<br>Intensity | Layers of 1 mm<br>or less for 20<br>seconds for a<br>curing light with<br>>1000 mW/cm²<br>or 30 seconds for<br>a curing light<br>with 400-1000<br>mW/cm² | Layers of 1mm or less<br>for 20 seconds; light<br>intensity not specified in<br>IFU. | Layers of 1.5 mm or less<br>for 20 seconds to a 3M<br>curing light manufactured<br>by 3M or other curing<br>unit of comparable<br>intensity | Both 3M VitCal Liner/Base and TheraCal LC<br>are cured incrementally in layers of 1mm or<br>less. | | Calcium Release | > 0 µg/g | > 0 µg/g | Does not release calcium | Both 3M VitCal Liner/Base and TheraCal LC<br>release calcium. Vitrebond Plus is not<br>designed with this characteristic. | | Fluoride Release | > 0 µg/g | Does not release<br>fluoride | > 0 µg/g | designed with this characteristic.<br>TheraCal LC does not release fluoride, but<br>Vitrebond Plus does. This difference does not<br>raise different questions of safety or<br>effectiveness. | | Phosphate Release | > 0 µg/g | Does not release<br>phosphate | Does not release<br>phosphate | effectiveness.<br>Vitrebond Plus and TheraCal LC are not<br>designed to release phosphate; however, this<br>difference does not raise any new questions<br>about safety or effectiveness as dental<br>materials with the same intended use as 3M<br>VitCal Liner/Base also release phosphate<br>(i.e., Lime-Lite™ ENHANCED1 cleared<br>under K153249). | | Dispensing System | Intra-oral, multi-<br>unit Micro-Mix<br>syringe with<br>single-use tips | Intra-oral, multi-unit<br>syringe with single-use<br>tips | Extra-oral, multi-unit<br>clicker | The essential design is the same. All devices<br>are dispensed from a multi-unit syringe or<br>clicker, and 3M VitCal Liner/Base and<br>TheraCal LC are dispensed intra-orally,<br>whereas Vitrebond Plus is dispensed extra-<br>orally. Differences do not raise any new<br>questions of safety or effectiveness. | | Sterility | Non-sterile | Non-sterile | Non-sterile | questions of safety or effectiveness.<br>All devices are not labeled as sterile products. | | Nanomaterials | Contains<br>nanomaterial | Unknown | Contains nanomaterial | The nanomaterials in 3M VitCal Liner/Base<br>are used in other FDA-cleared 3M dental<br>products with similar tissue contact types,<br>duration of use, and purpose in the<br>formulation. Based on a review of the<br>functions of the nanomaterials used in this<br>product, there are no appropriate larger-scale<br>alternatives. This difference, compared to the<br>predicate device, does not raise different<br>questions about safety or effectiveness. | | Materials | Portland cement,<br>silane-treated<br>silica,<br>methacrylate<br>polymer,<br>photoinitiators | Mineral trioxide<br>aggregate, methacrylate<br>polymer, photoinitiators | Silane-treated silica,<br>methacrylate polymer,<br>photoinitiators | The essential design of light-cured resin-<br>modified dental restorative materials includes<br>fillers, resin, and curing agents. All three<br>products share the same essential design.<br>Differences do not raise any new questions<br>about safety or effectiveness. | Page 2 of 5 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the 3M logo. The logo consists of the number "3" and the letter "M" in a bold, sans-serif font. The color of the text is red. The background is white. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the 3M logo. The logo is red and features the number "3" followed by the letter "M". The logo is simple and recognizable, and it is often used on 3M products and marketing materials. | Substantial Equivalence – Bench Test | | | | | | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|-------------------------|-----------------------------------|----------------------| | PHYSICAL<br>PROPERTIES | Specification | Units/ Additional Details | 3M VitCal<br>Liner/Base | TheraCal LC | 3M Vitrebond<br>Plus | | Compressive<br>Strength | ≥ 69 MPa | MPa | 103 ± 10 | Could not be<br>cured effectively | 102 ± 6 | | Flexural Strength | ≥ 10 MPa | MPa | 25 ± 3 | 16 ± 2 | 27 ± 1 | | Surface Hardness<br>(Barcol) | Barcol hardness on the bottom of the<br>sample must be ≥ 80% of the hardness | % with curing light distance<br>0 mm | 98 ± 8% | 84 ± 3% | 109 ± 15% | | | on the top of the sample - Using a<br>curing light with an approximate<br>intensity of 950 mW/cm² for 20<br>seconds | % with curing light distance<br>7 mm | 93 ± 3% | 60 ± 4% | 101 ± 6% | | | Barcol hardness on the bottom of the<br>sample must be ≥ 80% of the hardness | % with curing light distance<br>0 mm | 94 ± 4% | | 92 ± 2% | | | on the top of the sample - Using a<br>curing light with an approximate<br>intensity of 400 mW/cm² for 30<br>seconds | % with curing light distance<br>7 mm | 89 ± 11% | Not tested. | 101 ± 8% | | Radiopacity | ≥ 1.0 mm Aluminum Standard<br>(mmAl) | mmAl | 1.52 ± 0.05 | 1.56 ± 0.01 | 1.33 ± 0.04 | | Calcium Release | > 0 µg/g (Pass/Fail) | Cumulative amount for seven<br>days | Pass | Pass | Not applicable. | | Fluoride Release | > 0 µg/g (Pass/Fail) | Cumulative amount for seven<br>days | Pass | Not applicable. | Pass | | Phosphate Release | > 0 µg/g (Pass/Fail) | Cumulative amount for seven<br>days | Pass | Not applicable. | Not applicable. | | Working Time | >1.5 minutes | minutes | 2.44 ± 0.0 | N/A, one part | 2.5 per IFU | | Shear Bond<br>Strength to Dentin | >4 MPa | MPa, adhesion to 3M<br>Scotchbond Universal | 6 ± 3 | 2 ± 1 | 9 ± 3 | | | | MPa, adhesion to 3M Adper<br>Single Bond Plus Adhesive | 6 ± 2 | Not tested. | 13 ± 1 | | | | MPa, adhesion to 3M<br>Scotchbond Multi-Purpose<br>Plus Adhesive | 8 ± 3 | Not tested. | 13 ± 2 | | | | MPa, adhesion to Kuraray<br>CLEARFIL™ SE BOND<br>Adhesive | 6 ± 3 | Not tested. | 8 ± 3 | | Dentin Tubule<br>Occlusion2 | Tag formation into dentinal tubules<br>must be observed under scanning<br>electron microscopy (SEM) imaging | Yes/No | Yes | Yes | Yes | ² Only 1 lot of 3M VitCal was tested. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the 3M logo in red, with the word "Confidential" written in black below it. The 3M logo is a stylized version of the number 3, with the letters "M" following it. The word "Confidential" is written in a bold, sans-serif font. The logo is simple and recognizable, and the word "Confidential" adds a sense of secrecy or importance. # Biocompatibility Assessment VitCal Liner/Base was assessed as an external communicating device that is intended to be in contact with the body for greater than 30 days (ISO 10993, ISO 7405, FDA-2013-D-0350, and PFSB). In accordance with the combined guidance found in ISO 10993, ISO 7405, Testing guidelines outlined in the US FDA Docket Number FDA-2013-D-0350, and Japan: PSEHB/MDED No. 0106-1 and 0612-4, the following endpoints below must be considered in the biocompatibility evaluation of this product: Physical and/or Chemical Information, Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Subacute Toxicity, Genotoxicity, and Implantation. A Diplomate of the American Board of Toxicology has assessed the safety of this product and has determined that it is safe for its intended use. # Statement of Substantial Equivalence The indications for use of 3M VitCal Liner/Base are the same as TheraCal LC and similar to Vitrebond Plus. 3M VitCal Liner/Base technological characteristics are similar but not identical to TheraCal LC and 3M Vitrebond Plus. All three devices are resin-based, radiopaque, lightcured dental materials with similar dispensing systems. Differences in technological characteristics of the subject device and the primary predicate devices have been evaluated in accordance with the Agency's Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] dated July 28, 2014. Differences in the technological characteristics of 3M VitCal Liner/Base, compared to TheraCal LC and Vitrebond Plus, do not raise significant concerns about safety or effectiveness. Bench testing was conducted to compare the performance of 3M VitCal Liner/Base to TheraCal LC and 3M Vitrebond Plus. Testing demonstrates that the safety and performance of 3M VitCal Liner/Base are substantially equivalent to the predicate device.