(6 days)
Not Found
No
The device description and performance studies focus on the material properties and dispensing system of a dental liner/base, with no mention of AI or ML.
Yes
The device is indicated for direct pulp capping, which is a therapeutic intervention involving material placed directly on exposed pulp, hence classifying it as a therapeutic device.
No
This device is a dental liner/base material used for applications under dental restorations and direct pulp capping. Its function is to provide a protective layer and aid in the restoration process, not to diagnose a condition.
No
The device description clearly states it is a "two-part paste/paste, light-cured system" and describes its composition as a combination of materials, indicating it is a physical substance, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "lining and basing applications under dental restorations" and "direct pulp capping." These are procedures performed directly on the patient's tooth, not on samples taken from the body for diagnostic purposes.
- Device Description: The device is a "two-part paste/paste, light-cured system" applied directly to the tooth. It's a material used in a dental procedure.
- Lack of Diagnostic Function: The description focuses on the material's properties (adhesion, fluoride release, pH, strength, radiopacity, etc.) and its application in a restorative dental context. There is no mention of analyzing samples or providing diagnostic information about a patient's health condition.
- Anatomical Site: The anatomical site is the "Tooth," which is consistent with a dental restorative material, not an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EJK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Compressive Strength: 103 ± 10 MPa (3M VitCal Liner/Base); 102 ± 6 MPa (3M Vitrebond Plus)
Flexural Strength: 25 ± 3 MPa (3M VitCal Liner/Base); 16 ± 2 MPa (TheraCal LC); 27 ± 1 MPa (3M Vitrebond Plus)
Surface Hardness (Barcol): 98 ± 8% (0 mm curing light distance), 93 ± 3% (7 mm curing light distance) for 3M VitCal Liner/Base with 950 mW/cm²; 84 ± 3% (0 mm curing light distance), 60 ± 4% (7 mm curing light distance) for TheraCal LC with 950 mW/cm²; 109 ± 15% (0 mm curing light distance), 101 ± 6% (7 mm curing light distance) for 3M Vitrebond Plus with 950 mW/cm².
Surface Hardness (Barcol): 94 ± 4% (0 mm curing light distance), 89 ± 11% (7 mm curing light distance) for 3M VitCal Liner/Base with 400 mW/cm²; 92 ± 2% (0 mm curing light distance), 101 ± 8% (7 mm curing light distance) for 3M Vitrebond Plus with 400 mW/cm².
Radiopacity: 1.52 ± 0.05 mmAl (3M VitCal Liner/Base); 1.56 ± 0.01 mmAl (TheraCal LC); 1.33 ± 0.04 mmAl (3M Vitrebond Plus)
Calcium Release: Pass (3M VitCal Liner/Base); Pass (TheraCal LC)
Fluoride Release: Pass (3M VitCal Liner/Base); Pass (3M Vitrebond Plus)
Phosphate Release: Pass (3M VitCal Liner/Base)
Working Time: 2.44 ± 0.0 minutes (3M VitCal Liner/Base); 2.5 minutes (3M Vitrebond Plus)
Shear Bond Strength to Dentin: 6 ± 3 MPa (adhesion to 3M Scotchbond Universal), 6 ± 2 MPa (adhesion to 3M Adper Single Bond Plus Adhesive), 8 ± 3 MPa (adhesion to 3M Scotchbond Multi-Purpose Plus Adhesive), 6 ± 3 MPa (adhesion to Kuraray CLEARFIL™ SE BOND Adhesive) for 3M VitCal Liner/Base; 2 ± 1 MPa (adhesion to 3M Scotchbond Universal) for TheraCal LC; 9 ± 3 MPa (adhesion to 3M Scotchbond Universal), 13 ± 1 MPa (adhesion to 3M Adper Single Bond Plus Adhesive), 13 ± 2 MPa (adhesion to 3M Scotchbond Multi-Purpose Plus Adhesive), 8 ± 3 MPa (adhesion to Kuraray CLEARFIL™ SE BOND Adhesive) for 3M Vitrebond Plus.
Dentin Tubule Occlusion: Yes (3M VitCal Liner/Base); Yes (TheraCal LC); Yes (3M Vitrebond Plus)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
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)
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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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
2510 Conway Avenue
St. Paul, MN 55144, USA
Establishment Registration No.: 3005174370 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Primary Contact........................ | Chandrapaul(CP) Parsram, M.S.
Regulatory Affairs Associate
Phone: (651) 467 3014
cparsram@mmm.com |
| Secondary Contact........................ | Suzanne Leung, Ph.D.
Regulatory Affairs Director
Phone: (651) 575 8052
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
Predicate) | 3M™ Vitrebond™ Plus
(Secondary Predicate) |
|---------------|------------------------------------------------------------------|------------------------------------------------------------------------|
| Manufacturer | Bisco, Inc.
1100 WEST IRVING PARK RD.
SCHAUMBURG, IL 60193 | 3M ESPE Dental Products
2510 Conway Avenue
Saint Paul, MN, 55144 |
| 510(k) Number | K063237 | K011200 |
| Device Class | 2 | 2 |
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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 | |||
| Product | ||||
| Code | EMA - Cement, Dental | EJK - Liner, Cavity, Calcium | ||
| Hydroxide | EMA - Cement, Dental | The product code is the same | ||
| for 3M VitCal Liner/Base and | ||||
| 3M Vitrebond Plus. | ||||
| Regulation | 872.3275 - Dental cement | 872.3250 - Calcium hydroxide | ||
| cavity liner | 872.3275 - Dental cement | The regulation is the same for | ||
| 3M VitCal Liner/Base and 3M | ||||
| Vitrebond Plus. | ||||
| Intended | ||||
| Use per | ||||
| Regulation | 872.3275(b)(1) Dental cement other | |||
| than zinc oxide-eugenol is a device | ||||
| composed of various materials other | ||||
| than zinc oxide-eugenol | ||||
| intended......to be applied to a | ||||
| tooth to protect the tooth pulp. | 872.3250(a) 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. | 872.3275(b)(1) Dental cement | |||
| other than zinc oxide-eugenol is | ||||
| a device composed of various | ||||
| materials other than zinc oxide- | ||||
| eugenol intended......to be | ||||
| applied to a tooth to protect the | ||||
| tooth pulp. | Dental cements and calcium | |||
| hydroxide cavity liners are both | ||||
| intended for use in dental | ||||
| restorative procedures to | ||||
| protect the pulp. | ||||
| Indications | ||||
| for Use - | ||||
| 510(k) | Liner/base, Pulp capping | Liner, Pulp capping agent | Vitrebond Plus liner/base is | |
| indicated for lining and basing | ||||
| applications under the | ||||
| following restorations: | ||||
| Composite; Amalgam; | ||||
| Ceramic; Metal | 3M VitCal Liner/Base and | |||
| TheraCal LC have the same | ||||
| indications for use. Both | ||||
| devices are indicated for use in | ||||
| pulp capping and lining/basing | ||||
| applications. Although not | ||||
| explicitly stated in the 510(k) | ||||
| clearance, TheraCal LC is | ||||
| currently labeled for basing | ||||
| applications. | ||||
| All three devices are indicated | ||||
| for use in liner/base | ||||
| applications. | ||||
| Substantial Equivalence – Technological Characteristics | ||||
| Device | 3M VitCal | |||
| Liner/Base | ||||
| (Subject Device) | TheraCal LC | |||
| (Primary Predicate, | ||||
| K063237) | 3M Vitrebond Plus | |||
| (Secondary Predicate, | ||||
| K011200) | Comparison | |||
| Number of | ||||
| Components | Two (paste/paste) | One | Two (paste/liquid) | 3M VitCal Liner/Base differs from TheraCal |
| LC but is similar to Vitrebond Plus. This | ||||
| difference does not raise different questions | ||||
| about safety or effectiveness as two-part | ||||
| liner/base, and pulp capping materials are | ||||
| common, established technology in dental | ||||
| preparations, i.e., Vitrebond Plus. | ||||
| ISO 9917-2 Class | Class 2, Base or | |||
| Lining | Not applicable. | Class 2, Base or Lining | TheraCal LC does not claim compliance to | |
| ISO 9917-2 Dentistry - Water-based cements | ||||
| Part 2: Resin-modified cements. Both 3M | ||||
| VitCal Liner/Base and Vitrebond Plus meet | ||||
| the requirements for working time, flexural | ||||
| strength, and radiopacity as ISO 9917-2 Class | ||||
| 2 Base/Liner materials. This difference does | ||||
| not raise different questions of safety or | ||||
| effectiveness. | ||||
| Working Time per | ||||
| Annex A of ISO | ||||
| 9917-2 | ≥1.5 minutes | Not labeled | ≥1.5 minutes | VitCal Liner/Base and Vitrebond Plus meet |
| the requirements for working time, flexural | ||||
| strength, and radiopacity as ISO 9917-2 Class | ||||
| Flexural Strength | ||||
| per Annex C of ISO | ||||
| 9917-2 | ≥10 MPa | Not labeled | ≥10 MP | 2 Base/Liner materials. This difference does |
| not raise different questions of safety or | ||||
| effectiveness. | ||||
| Radiopacity per | ||||
| Annex D of 9917-2 | ||||
| and ISO 13116 | ≥1.0 mm | |||
| Aluminum | ||||
| Standard (mmAl) | ≥1.0 mm Aluminum | |||
| Standard (mmAl) | ≥1.0 mm Aluminum | |||
| Standard (mmAl) | ||||
| Setting Mechanism | Light cure | Light cure | Light cure | All devices are light-cured. |
| Cure Time and | ||||
| Intensity | Layers of 1 mm | |||
| or less for 20 | ||||
| seconds for a | ||||
| curing light with |
1000 mW/cm²
or 30 seconds for
a curing light
with 400-1000
mW/cm² | Layers of 1mm or less
for 20 seconds; light
intensity not specified in
IFU. | Layers of 1.5 mm or less
for 20 seconds to a 3M
curing light manufactured
by 3M or other curing
unit of comparable
intensity | Both 3M VitCal Liner/Base and TheraCal LC
are cured incrementally in layers of 1mm or
less. |
| Calcium Release | > 0 µg/g | > 0 µg/g | Does not release calcium | Both 3M VitCal Liner/Base and TheraCal LC
release calcium. Vitrebond Plus is not
designed with this characteristic. |
| Fluoride Release | > 0 µg/g | Does not release
fluoride | > 0 µg/g | designed with this characteristic.
TheraCal LC does not release fluoride, but
Vitrebond Plus does. This difference does not
raise different questions of safety or
effectiveness. |
| Phosphate Release | > 0 µg/g | Does not release
phosphate | Does not release
phosphate | effectiveness.
Vitrebond Plus and TheraCal LC are not
designed to release phosphate; however, this
difference does not raise any new questions
about safety or effectiveness as dental
materials with the same intended use as 3M
VitCal Liner/Base also release phosphate
(i.e., Lime-Lite™ ENHANCED1 cleared
under K153249). |
| Dispensing System | Intra-oral, multi-
unit Micro-Mix
syringe with
single-use tips | Intra-oral, multi-unit
syringe with single-use
tips | Extra-oral, multi-unit
clicker | The essential design is the same. All devices
are dispensed from a multi-unit syringe or
clicker, and 3M VitCal Liner/Base and
TheraCal LC are dispensed intra-orally,
whereas Vitrebond Plus is dispensed extra-
orally. Differences do not raise any new
questions 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 | Contains
nanomaterial | Unknown | Contains nanomaterial | The nanomaterials in 3M VitCal Liner/Base
are used in other FDA-cleared 3M dental
products with similar tissue contact types,
duration of use, and purpose in the
formulation. Based on a review of the
functions of the nanomaterials used in this
product, there are no appropriate larger-scale
alternatives. This difference, compared to the
predicate device, does not raise different
questions about safety or effectiveness. |
| Materials | Portland cement,
silane-treated
silica,
methacrylate
polymer,
photoinitiators | Mineral trioxide
aggregate, methacrylate
polymer, photoinitiators | Silane-treated silica,
methacrylate polymer,
photoinitiators | The essential design of light-cured resin-
modified dental restorative materials includes
fillers, resin, and curing agents. All three
products share the same essential design.
Differences do not raise any new questions
about safety or effectiveness. |
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| Substantial Equivalence – Bench Test | |||||
|---|---|---|---|---|---|
| PHYSICAL | |||||
| PROPERTIES | Specification | Units/ Additional Details | 3M VitCal | ||
| Liner/Base | TheraCal LC | 3M Vitrebond | |||
| Plus | |||||
| 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) | Barcol hardness on the bottom of the | ||||
| sample must be ≥ 80% of the hardness | % with curing light distance | ||||
| 0 mm | 98 ± 8% | 84 ± 3% | 109 ± 15% | ||
| on the top of the sample - Using a | |||||
| curing light with an approximate | |||||
| intensity of 950 mW/cm² for 20 | |||||
| seconds | % with curing light distance | ||||
| 7 mm | 93 ± 3% | 60 ± 4% | 101 ± 6% | ||
| Barcol hardness on the bottom of the | |||||
| sample must be ≥ 80% of the hardness | % with curing light distance | ||||
| 0 mm | 94 ± 4% | 92 ± 2% | |||
| on the top of the sample - Using a | |||||
| curing light with an approximate | |||||
| intensity of 400 mW/cm² for 30 | |||||
| seconds | % with curing light distance | ||||
| 7 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 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 | |||||
| Occlusion2 | Tag formation into dentinal tubules | ||||
| must be observed under scanning | |||||
| electron microscopy (SEM) imaging | Yes/No | Yes | Yes | Yes |
2 Only 1 lot of 3M VitCal was tested.
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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.