(6 days)
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.
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.
The provided text is a 510(k) Premarket Notification for a dental product, 3M™ VitCal Liner/Base. It details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.
It is important to note that this document is for a DENTAL LINER/BASE material, NOT an AI-powered medical device for diagnosis or image analysis. Therefore, the requested information regarding AI study design, such as MRMC studies, expert adjudication for ground truth, sample sizes for training/test sets in an AI context, and effect sizes of human readers with AI assistance, is not applicable to this submission.
The acceptance criteria and "study" proving the device meets them, in this context, refer to bench testing of physical, chemical, and biological properties (biocompatibility) to demonstrate that the new dental material performs comparably or acceptably to existing predicate devices.
Here's the relevant information extracted from the document, tailored to the type of device:
1. Table of Acceptance Criteria and the Reported Device Performance (Bench Test Results):
| Physical Properties Acceptance Criteria | Units/Additional Details | 3M VitCal Liner/Base Reported Performance | TheraCal LC (Primary Predicate) Reported Performance | 3M Vitrebond Plus (Secondary Predicate) Reported Performance |
|---|---|---|---|---|
| Compressive Strength ≥ 69 MPa | MPa | 103 ± 10 | Could not be cured effectively | 102 ± 6 |
| Flexural Strength ≥ 10 MPa | MPa | 25 ± 3 | 16 ± 2 | 27 ± 1 |
| Surface Hardness (Barcol) ≥ 80% (0 mm) | % with curing light distance 0 mm (using ~950 mW/cm² for 20s) | 98 ± 8% | 84 ± 3% | 109 ± 15% |
| Surface Hardness (Barcol) ≥ 80% (7 mm) | % with curing light distance 7 mm (using ~950 mW/cm² for 20s) | 93 ± 3% | 60 ± 4% | 101 ± 6% |
| Surface Hardness (Barcol) ≥ 80% (0 mm) | % with curing light distance 0 mm (using ~400 mW/cm² for 30s) | 94 ± 4% | 92 ± 2% | |
| Surface Hardness (Barcol) ≥ 80% (7 mm) | % with curing light distance 7 mm (using ~400 mW/cm² for 30s) | 89 ± 11% | Not tested. | 101 ± 8% |
| Radiopacity ≥ 1.0 mm Aluminum Standard | mmAl | 1.52 ± 0.05 | 1.56 ± 0.01 | 1.33 ± 0.04 |
| Calcium Release > 0 µg/g (Pass/Fail) | Cumulative amount for seven days | Pass | Pass | Not applicable. |
| Fluoride Release > 0 µg/g (Pass/Fail) | Cumulative amount for seven days | Pass | Not applicable. | Pass |
| Phosphate Release > 0 µg/g (Pass/Fail) | Cumulative amount for seven 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 Strength to Dentin > 4 MPa | MPa, adhesion to 3M Scotchbond Universal | 6 ± 3 | 2 ± 1 | 9 ± 3 |
| MPa, adhesion to 3M Adper Single Bond Plus Adhesive | 6 ± 2 | Not tested. | 13 ± 1 | |
| MPa, adhesion to 3M Scotchbond Multi-Purpose Plus Adhesive | 8 ± 3 | Not tested. | 13 ± 2 | |
| MPa, adhesion to Kuraray CLEARFIL™ SE BOND Adhesive | 6 ± 3 | Not tested. | 8 ± 3 | |
| Dentin Tubule Occlusion: Tag formation observed under SEM | Yes/No | Yes | Yes | Yes |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Bench Tests: The specific number of samples (e.g., n=5, n=10) for each individual bench test (e.g., compressive strength, flexural strength) is not explicitly detailed in this summary. However, standard deviations are provided for most quantitative measurements (e.g., 103 ± 10), implying multiple replicates were used for testing. For "Dentin Tubule Occlusion," it states "Only 1 lot of 3M VitCal was tested."
- Data Provenance: The data is generated from laboratory bench testing of the dental material. The document does not specify a country of origin for the testing, but the submitting company (3M ESPE Dental Products) is based in St. Paul, MN, USA. The testing is prospective in the sense that it's performed specifically to characterize the device for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This question is not applicable as the "test set" here refers to physical and chemical properties measured in a lab, not clinical images or patient data analyzed by experts.
- For biocompatibility assessment, it states: "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." This is an expert opinion on the safety, but not "ground truth" derived from patient data.
4. Adjudication Method for the Test Set:
- This question is not applicable as there is no expert reading or interpretation of "cases" involved. Performance is based on direct physical and chemical measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was NOT done. This type of study is relevant for AI systems that assist human readers in tasks like image interpretation, which is not the function of this dental liner/base material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not an algorithm. This is a physical dental material. The "standalone performance" is represented by the bench test results of the material itself.
7. The Type of Ground Truth Used:
- The "ground truth" for this device is based on established industry standards and physical/chemical measurements (e.g., ISO 9917-2 standards for dental cements, ASTM/ISO standards for mechanical properties, and analytical chemistry methods for ion release). For biocompatibility, it's based on toxicological assessments against established biological safety standards (e.g., ISO 10993).
8. The Sample Size for the Training Set:
- Not applicable. This device is a material, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. This device is a material, not an AI model, and therefore has no "training set."
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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.
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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 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
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Indications for Use
Submission Number (if known)
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)
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This 510(k) summary is submitted in accordance with the requirements of 21 CFR §807.92
Submitter Information
| 510(k) Submitter........................ | 3M ESPE Dental Products2510 Conway AvenueSt. Paul, MN 55144, USAEstablishment Registration No.: 3005174370 |
|---|---|
| Primary Contact........................ | Chandrapaul(CP) Parsram, M.S.Regulatory Affairs AssociatePhone: (651) 467 3014cparsram@mmm.com |
| Secondary Contact........................ | Suzanne Leung, Ph.D.Regulatory Affairs DirectorPhone: (651) 575 8052sleung2@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® (PrimaryPredicate) | 3M™ Vitrebond™ Plus(Secondary Predicate) |
|---|---|---|
| Manufacturer | Bisco, Inc.1100 WEST IRVING PARK RD.SCHAUMBURG, IL 60193 | 3M ESPE Dental Products2510 Conway AvenueSaint Paul, MN, 55144 |
| 510(k) Number | K063237 | K011200 |
| Device Class | 2 | 2 |
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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(Subject Device) | TheraCal LC(Primary Predicate,K063237) | 3M Vitrebond Plus(Secondary Predicate,K011200) | Comparison |
| ProductCode | EMA - Cement, Dental | EJK - Liner, Cavity, CalciumHydroxide | EMA - Cement, Dental | The product code is the samefor 3M VitCal Liner/Base and3M Vitrebond Plus. |
| Regulation | 872.3275 - Dental cement | 872.3250 - Calcium hydroxidecavity liner | 872.3275 - Dental cement | The regulation is the same for3M VitCal Liner/Base and 3MVitrebond Plus. |
| IntendedUse perRegulation | 872.3275(b)(1) Dental cement otherthan zinc oxide-eugenol is a devicecomposed of various materials otherthan zinc oxide-eugenolintended......to be applied to atooth to protect the tooth pulp. | 872.3250(a) A calcium hydroxidecavity liner is a device materialintended to be applied to theinterior of a prepared cavitybefore insertion of restorativematerial, such as amalgam, toprotect the pulp of a tooth. | 872.3275(b)(1) Dental cementother than zinc oxide-eugenol isa device composed of variousmaterials other than zinc oxide-eugenol intended......to beapplied to a tooth to protect thetooth pulp. | Dental cements and calciumhydroxide cavity liners are bothintended for use in dentalrestorative procedures toprotect the pulp. |
| Indicationsfor Use -510(k) | Liner/base, Pulp capping | Liner, Pulp capping agent | Vitrebond Plus liner/base isindicated for lining and basingapplications under thefollowing restorations:Composite; Amalgam;Ceramic; Metal | 3M VitCal Liner/Base andTheraCal LC have the sameindications for use. Bothdevices are indicated for use inpulp capping and lining/basingapplications. Although notexplicitly stated in the 510(k)clearance, TheraCal LC iscurrently labeled for basingapplications.All three devices are indicatedfor use in liner/baseapplications. |
| Substantial Equivalence – Technological Characteristics | ||||
| Device | 3M VitCalLiner/Base(Subject Device) | TheraCal LC(Primary Predicate,K063237) | 3M Vitrebond Plus(Secondary Predicate,K011200) | Comparison |
| Number ofComponents | Two (paste/paste) | One | Two (paste/liquid) | 3M VitCal Liner/Base differs from TheraCalLC but is similar to Vitrebond Plus. Thisdifference does not raise different questionsabout safety or effectiveness as two-partliner/base, and pulp capping materials arecommon, established technology in dentalpreparations, i.e., Vitrebond Plus. |
| ISO 9917-2 Class | Class 2, Base orLining | Not applicable. | Class 2, Base or Lining | TheraCal LC does not claim compliance toISO 9917-2 Dentistry - Water-based cementsPart 2: Resin-modified cements. Both 3MVitCal Liner/Base and Vitrebond Plus meetthe requirements for working time, flexuralstrength, and radiopacity as ISO 9917-2 Class2 Base/Liner materials. This difference doesnot raise different questions of safety oreffectiveness. |
| Working Time perAnnex A of ISO9917-2 | ≥1.5 minutes | Not labeled | ≥1.5 minutes | VitCal Liner/Base and Vitrebond Plus meetthe requirements for working time, flexuralstrength, and radiopacity as ISO 9917-2 Class |
| Flexural Strengthper Annex C of ISO9917-2 | ≥10 MPa | Not labeled | ≥10 MP | 2 Base/Liner materials. This difference doesnot raise different questions of safety oreffectiveness. |
| Radiopacity perAnnex D of 9917-2and ISO 13116 | ≥1.0 mmAluminumStandard (mmAl) | ≥1.0 mm AluminumStandard (mmAl) | ≥1.0 mm AluminumStandard (mmAl) | |
| Setting Mechanism | Light cure | Light cure | Light cure | All devices are light-cured. |
| Cure Time andIntensity | Layers of 1 mmor less for 20seconds for acuring light with>1000 mW/cm²or 30 seconds fora curing lightwith 400-1000mW/cm² | Layers of 1mm or lessfor 20 seconds; lightintensity not specified inIFU. | Layers of 1.5 mm or lessfor 20 seconds to a 3Mcuring light manufacturedby 3M or other curingunit of comparableintensity | Both 3M VitCal Liner/Base and TheraCal LCare cured incrementally in layers of 1mm orless. |
| Calcium Release | > 0 µg/g | > 0 µg/g | Does not release calcium | Both 3M VitCal Liner/Base and TheraCal LCrelease calcium. Vitrebond Plus is notdesigned with this characteristic. |
| Fluoride Release | > 0 µg/g | Does not releasefluoride | > 0 µg/g | designed with this characteristic.TheraCal LC does not release fluoride, butVitrebond Plus does. This difference does notraise different questions of safety oreffectiveness. |
| Phosphate Release | > 0 µg/g | Does not releasephosphate | Does not releasephosphate | effectiveness.Vitrebond Plus and TheraCal LC are notdesigned to release phosphate; however, thisdifference does not raise any new questionsabout safety or effectiveness as dentalmaterials with the same intended use as 3MVitCal Liner/Base also release phosphate(i.e., Lime-Lite™ ENHANCED1 clearedunder K153249). |
| Dispensing System | Intra-oral, multi-unit Micro-Mixsyringe withsingle-use tips | Intra-oral, multi-unitsyringe with single-usetips | Extra-oral, multi-unitclicker | The essential design is the same. All devicesare dispensed from a multi-unit syringe orclicker, and 3M VitCal Liner/Base andTheraCal LC are dispensed intra-orally,whereas Vitrebond Plus is dispensed extra-orally. Differences do not raise any newquestions of safety or effectiveness. |
| Sterility | Non-sterile | Non-sterile | Non-sterile | questions of safety or effectiveness.All devices are not labeled as sterile products. |
| Nanomaterials | Containsnanomaterial | Unknown | Contains nanomaterial | The nanomaterials in 3M VitCal Liner/Baseare used in other FDA-cleared 3M dentalproducts with similar tissue contact types,duration of use, and purpose in theformulation. Based on a review of thefunctions of the nanomaterials used in thisproduct, there are no appropriate larger-scalealternatives. This difference, compared to thepredicate device, does not raise differentquestions about safety or effectiveness. |
| Materials | Portland cement,silane-treatedsilica,methacrylatepolymer,photoinitiators | Mineral trioxideaggregate, methacrylatepolymer, photoinitiators | Silane-treated silica,methacrylate polymer,photoinitiators | The essential design of light-cured resin-modified dental restorative materials includesfillers, resin, and curing agents. All threeproducts share the same essential design.Differences do not raise any new questionsabout safety or effectiveness. |
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| Substantial Equivalence – Bench Test | |||||
|---|---|---|---|---|---|
| PHYSICALPROPERTIES | Specification | Units/ Additional Details | 3M VitCalLiner/Base | TheraCal LC | 3M VitrebondPlus |
| CompressiveStrength | ≥ 69 MPa | MPa | 103 ± 10 | Could not becured effectively | 102 ± 6 |
| Flexural Strength | ≥ 10 MPa | MPa | 25 ± 3 | 16 ± 2 | 27 ± 1 |
| Surface Hardness(Barcol) | Barcol hardness on the bottom of thesample must be ≥ 80% of the hardness | % with curing light distance0 mm | 98 ± 8% | 84 ± 3% | 109 ± 15% |
| on the top of the sample - Using acuring light with an approximateintensity of 950 mW/cm² for 20seconds | % with curing light distance7 mm | 93 ± 3% | 60 ± 4% | 101 ± 6% | |
| Barcol hardness on the bottom of thesample must be ≥ 80% of the hardness | % with curing light distance0 mm | 94 ± 4% | 92 ± 2% | ||
| on the top of the sample - Using acuring light with an approximateintensity of 400 mW/cm² for 30seconds | % with curing light distance7 mm | 89 ± 11% | Not tested. | 101 ± 8% | |
| Radiopacity | ≥ 1.0 mm Aluminum Standard(mmAl) | mmAl | 1.52 ± 0.05 | 1.56 ± 0.01 | 1.33 ± 0.04 |
| Calcium Release | > 0 µg/g (Pass/Fail) | Cumulative amount for sevendays | Pass | Pass | Not applicable. |
| Fluoride Release | > 0 µg/g (Pass/Fail) | Cumulative amount for sevendays | Pass | Not applicable. | Pass |
| Phosphate Release | > 0 µg/g (Pass/Fail) | Cumulative amount for sevendays | Pass | Not applicable. | Not applicable. |
| Working Time | >1.5 minutes | minutes | 2.44 ± 0.0 | N/A, one part | 2.5 per IFU |
| Shear BondStrength to Dentin | >4 MPa | MPa, adhesion to 3MScotchbond Universal | 6 ± 3 | 2 ± 1 | 9 ± 3 |
| MPa, adhesion to 3M AdperSingle Bond Plus Adhesive | 6 ± 2 | Not tested. | 13 ± 1 | ||
| MPa, adhesion to 3MScotchbond Multi-PurposePlus Adhesive | 8 ± 3 | Not tested. | 13 ± 2 | ||
| MPa, adhesion to KurarayCLEARFIL™ SE BONDAdhesive | 6 ± 3 | Not tested. | 8 ± 3 | ||
| Dentin TubuleOcclusion2 | Tag formation into dentinal tubulesmust be observed under scanningelectron microscopy (SEM) imaging | Yes/No | Yes | Yes | Yes |
2 Only 1 lot of 3M VitCal was tested.
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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.
§ 872.3250 Calcium hydroxide cavity liner.
(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.