(280 days)
Apacal ART and is suitable for several indications including:
- · Liner to be applied to the interior of a prepared cavity prior to the insertion of restorative materials.
- · Indirect pulp capping or management of deep caries lesions, or
- · Direct pulp capping
CAL-LC is indicated for use as a cavity liner and pulp capping material. It is self-adhering and highly filled.
Calcigel is a calcium hydroxide paste that has a creamy consistency and is suitable for several indications including;
- · Indirect pulp capping or management of deep caries lesions, or
· Direct pulp capping
CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.
Apacal ART is a light cured single-component paste reinforced with tricalcium phosphate and hydroxyapatite. It is sold in a syringe with accompanying applicator tips.
CAL-LC is a highly filled cavity liner and pulp capping material. It is sold in a syringe with accompanying applicator tips.
Calcigel is a creamy, ready -to -use calcium hydroxide paste with a pH above 11. It is syringe with accompanying applicator tips.
CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent. CalUltra is a two-part base/catalyst paste/paste system. It is sold in a tubes with accompanying spatula and mixing pad.
The provided text describes the substantial equivalence of Prevest Denpro Cavity Liners to predicate devices, focusing on physical parameters and material composition rather than AI performance. Therefore, many of the requested categories related to AI studies and expert review are not applicable to this document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All tests results met the criteria in standards." The acceptance criteria are implicit in the ISO and USP standards referenced for each test. The performance is reported as meeting these standards.
| Device Name | Test | Standard Reference (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|---|---|
| Apacal ART & Cal LC | Appearance | ISO 9917-2:2017, ISO 4049:2019, ISO 13116:2014 | Met standards |
| Flexural Strength | ISO 9917-2:2017 (e.g., for Apacal ART: 99.1 MPa; for CAL-LC: 96.3 MPa) | Met standards | |
| Depth of Cure | ISO 4049:2019 | Met standards | |
| Water Sorption | ISO 4049:2019 (e.g., for Apacal ART: 13.6 µg/mm³; for CAL-LC: Data not specified but implied to meet standards) | Met standards | |
| Water Solubility | ISO 4049:2019 (e.g., for Apacal ART: 4.5 µg/mm³; for CAL-LC: Data not specified but implied to meet standards) | Met standards | |
| Radio-opacity | ISO 13116:2014 | Met standards | |
| Calcigel | Appearance | ISO 6876:2012 | Met standards |
| Flow | ISO 6876:2012 | Met standards | |
| pH | USP 971 (e.g., 11-13) | Met standards | |
| Radio-opacity | ISO 13116:2014 | Met standards | |
| CalUltra | Appearance | ISO 9917-1:2017 | Met standards |
| Compressive Strength | ISO 9917-1:2017 | Met standards | |
| Water Solubility | ISO 6876:2012 (e.g., 3.8%) | Met standards | |
| Setting Time | ISO 6876:2012 (e.g., 1-3 minutes) | Met standards | |
| Radio-opacity | ISO 13116:2014 | Met standards | |
| pH | USP 971 (e.g., 9.2) | Met standards | |
| All Devices | Shelf Life | Relevant protocols (not specified in detail, but implied to meet standards) | 3 years |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the testing of these physical and chemical properties. The data provenance is presumed to be from the manufacturer's testing conducted in India (Prevest Denpro Limited, Jammu, India). The testing is described as being performed "according to protocols based on" relevant ISO and USP standards, indicating manufacturer-conducted in vitro/bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device clearance based on material properties and performance against established international standards, not an AI or diagnostic device requiring expert ground truth for image interpretation or similar tasks.
4. Adjudication method for the test set
Not applicable. This type of adjudication is typically used in clinical or image-based studies. The "adjudication" here is the assessment against specified ISO/USP standard requirements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a dental material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a dental material, not an algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is based on the objective measurements against established international and national standards (ISO and USP) for material properties (e.g., flexural strength, depth of cure, water sorption/solubility, pH, setting time, radio-opacity).
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 13, 2022
Prevest Denpro Limited c/o Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172
Re: K212475
Trade/Device Name: Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: Class II Product Code: EJK Dated: March 10, 2022 Received: March 15, 2022
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 (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.
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
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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, 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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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) K212475
Device Name
Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
Indications for Use (Describe)
Apacal ART and is suitable for several indications including:
- · Liner to be applied to the interior of a prepared cavity prior to the insertion of restorative materials.
- · Indirect pulp capping or management of deep caries lesions, or
- · Direct pulp capping
CAL-LC is indicated for use as a cavity liner and pulp capping material. It is self-adhering and highly filled.
Calcigel is a calcium hydroxide paste that has a creamy consistency and is suitable for several indications including;
- · Indirect pulp capping or management of deep caries lesions, or
· Direct pulp capping
CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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K212475
Prevest DenPro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) 510K Summary May 3, 2022
Name and Address: Prevest Denpro Limited Export Promotion Industrial Park Bari Brahmana, Jammu 181133 India Contact Person: Atul Modi Email: prevestindia@gmail.com Telephone: (941) 919 4280
Name of device: Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) Common name: cavity liner Classification Name: calcium hydroxide cavity liner CFR: 21 CFR 872.3250 Primary Product Code: EJK
Submission Contact:
Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 (704)450-9934 angela@blackwelldevice.com
Device Description:
Apacal ART is a light cured single-component paste reinforced with tricalcium phosphate and hydroxyapatite. It is sold in a syringe with accompanying applicator tips.
CAL-LC is a highly filled cavity liner and pulp capping material. It is sold in a syringe with accompanying applicator tips.
Calcigel is a creamy, ready -to -use calcium hydroxide paste with a pH above 11. It is syringe with accompanying applicator tips.
CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent. CalUltra is a two-part base/catalyst paste/paste system. It is sold in a tubes with accompanying spatula and mixing pad.
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Indications for Use:
| Device Name | Indications |
|---|---|
| Apacal ART | Apacal ART and is suitable for several indications including:Liner to be applied to the interior of a prepared cavity prior to the insertion of restorative materials. Indirect pulp capping or management of deep caries lesions, or Direct pulp capping |
| Cal LC | CAL-LC is indicated for use as a cavity liner and pulp capping material. It is self-adhering and highly filled. |
| Calcigel | Calcigel is a calcium hydroxide paste that has a creamy consistency and is suitable for several indications including:Indirect pulp capping or management of deep caries lesions, or Direct pulp capping |
| CalUltra | CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques. |
Testing Summary:
Apacal ART, and Cal LC were tested for appearance, flexural strength, depth of cure, water sorption/solubility, and radio-opacity according to protocols based on ISO 9917-2:2017, ISO 4049:2019 and ISO 13116:2014. Calcigel was tested for appearance and flow according to ISO 6876:2012, radioopacity according to ISO 13116: 2014 and pH according to USP 971. CalUltra was tested for appearance and compressive strength according to ISO 9917-1:2017, water solubility and setting time according to ISO 6876:2012, radio-opacity according to ISO 13116:2014, and pH according to USP 971.
Shelf life testing was completed on all devices using relevant protocols also used for the physical characteristics tested. Shelf life for all four cavity liners is 3 years.
All tests results met the criteria in standards.
The cavity liners contain ingredients found in the predicate and reference devices. They are used for the same type of contact, external communicating with contact to tissue/bone/dentin. The indications for
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use of the devices and the predicate devices are the same so the risks incurred for use of the ingredients are the same. Since no new risks are introduced, no biocompatibility testing was done.
Mechanism of Action: Apacal ART and Cal LC are light cured. Calcigel remains a paste with another cured material being placed on top of it to seal it. CalUltra cures via a base catalyst reaction.
Predicate Device: CleaniCal K201799
Additional Predicate Devices: Ultra Blend Plus K970113, Life Regular Set/ Life Fast Set K150559
Reference Devices: Cavios Calcium Hydroxide Cavity Liner K111668 (for ingredients),), RMGI Low Viscosity K123265 (for ingredients), DIAPASTE K190091 (for ingredients), Adseal K042769 (for ingredients), VLC Dycal II K922721 (for ingredients)
Substantial Equivalence:
The cavity liners have similar ingredicate and reference devices, the same indications for use, and similar physical parameter testing.
| Name | ApaCal ART (subjectdevice) | CleaniCal (predicatedevice) | Cavios CalciumHydroxide Cavity Liner(reference device foringredients) |
|---|---|---|---|
| 510k Number | K212475 | K201799 | K111668 |
| Common Name | Cavity Liner | Calcium HydroxidePaste | Cavity Liner |
| Classification Name | Calcium HydroxideCavity Liner | Calcium HydroxideCavity Liner | Calcium HydroxideCavity Liner |
| Class | II | II | II |
| Product Code | EJK | EJK, KIF | EJK |
| CFR | 872.3250 | 872.3250 | 872.3820 |
| Indications for Use | Apacal ART and issuitable for severalindications including:Liner to beapplied to theinterior of aprepared cavityprior to theinsertion ofrestorativematerials. Indirect pulpcapping ormanagementof deep carieslesions or | Cleanical is a calciumhydroxide paste thathas a creamyconsistency and issuitable for severalindications including:Temporarydisinfectantdressings in theobturation ofroot canals Indirect pulpcapping ormanagementof deep carieslesions or | Cavios cavity Liner is tobe applied to theinterior of a preparedcavity prior to theinsertion of restorativematerials. Cavios CavityLiner is indicated foruse in the generaldental population. |
Cavity Liners from Prevest Denpro
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| • Direct pulp capping | • Direct pulp capping | ||
|---|---|---|---|
| Device Description | Apacal ART is a lightcured single-component pastereinforced withtricalcium phosphateand hydroxyapatite. | Cleanical is a pre-filledsyringe of calciumhydroxide paste with apH of 12.3. | Cavios is a light curedsingle-componentyellow-white paste foruse as a dentin linerand paste. |
| Formula | urethanedimethyacrylate,triethylene glycoldimethacrylate,barium sulfate,silanated barium glasspowder,amorphous fumedsilica,tricalcium phosphate,hydroxyapatite,calcium hydroxide,photo initiators, andstablizers | Calcium hydroxideZirconium dioxideExcipients (n-Methyl-2-pyrrolidone,Hypromellose) | Urethanedimethacrylate,Tricalcium phosphateBarium sulfate, photoinitiator |
| Mechanism of Action | Light Cure | Unknown | Light Cure |
| Light Cure Time | 30-40 sec | Unknown | 20 sec |
| Water Sorption | 13.6 µg/mm³ | Unknown | 33 µg/mm³ |
| Water Solubility | 4.5 µg/mm³ | Unknown | 0.8 µg/mm³ |
| Flexural Strength | 99.1 MPa | Unknown | 59.9 MPa |
| Package | Pre-filled syringe | Pre-filled syringe | Pre-filled syringe |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Shelf Life | 3 years | 2 years | 3 years |
| Name | CAL-LC (subject device) | Ultra Blend Plus(additional predicatedevice) | RMGI Low Viscosity(reference device foringredients) |
|---|---|---|---|
| 510k Number | K212475 | K970113 | K123265 |
| Common Name | Cavity liner and/orbase material | Cavity liner and/orbase material | Dental cement, cavityliner |
| Classification Name | Calcium hydroxidecavity liner | Calcium hydroxidecavity liner | Dental cement, cavityliner |
| Class | II | II | II |
| Product Code | EJK | EJK | EMA, EJK |
| CFR | 872.3250 | 872.3250 | 872.3275 |
| Indications for Use | CAL-LC is indicated foruse as a cavity liner andpulp capping material. | Ultra Blend Plus isindicated for use as acavity liner and pulpcapping material. It is | Pulpdent RMGI LowViscosity is a resin-modified glass ionomerpreparation used by |
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| It is self-adhering andhighly filled. | self-adhering andhighly filled. | dental professionals asa liner, base, or lutingmaterial in dentalrestorations. | |
|---|---|---|---|
| Device Description | CAL-LC is a highly filledcavity liner and pulpcapping material. | Ultra Blend Plus is ahighly filled cavity linerand pulp cappingmaterial. | Pulpdent RGMI LowViscosity is a resin-modified glass ionomerin two pastes. |
| Formula | diurethanedimethyacrylate,Barium sulfate, calciumhydroxide,Silanated barium glasspowder,Amorphous fumedsilica,Photo initiators, andstablizers | Diurethanedimethacrylate, bariumsulfate, calciumhydroxide, calciumhydroxyapatite,triethylene glycoldimethacrylate, aminemethacrylate | Part A:Diurethanedimethacrylate,polyacrylic acid/maleicacid copolymer, water,barium borosilicateglass, silica, reducingagents, photo initiatorsPart B: Diurethanedimethacrylate,aluminofluorosilicateionomer glass, silica,oxidizing agents |
| Mechanism of Action | Light Cure | Light Cure | Light Cure |
| Flexural Strength | 96.3 MPa | Unknown | 88 MPa |
| Light Cure Time | 30-40 sec | 10 sec | 20 sec |
| Package | Pre-filled syringe | Pre-filled syringe | Auto-mix syringe |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Shelf Life | 3 years | Unknown | Unknown |
| Name | Calcigel (subject device) | CleaniCal (predicate device) | DIAPASTE (reference device for ingredients) |
|---|---|---|---|
| 510k Number | K212475 | K201799 | K190091 |
| Common Name | Calcium Hydroxide Paste | Calcium Hydroxide Paste | Root Canal Filling Resin |
| Classification Name | Calcium Hydroxide Cavity Liner | Calcium Hydroxide Cavity Liner | Root Canal Filling Resin |
| Class | II | II | II |
| Product Code | EJK | EJK, KIF | KIF |
| CFR | 872.3250 | 872.3250 | 872.3820 |
| Indications for Use | Calcigel is a calcium hydroxide paste that has a creamy consistency and is suitable for several indications including: | Cleanical is a calcium hydroxide paste that has a creamy consistency and is suitable for several indications including: | Aqueous ointment material that temporarily fills the root canal for the following indications:• Apexification |
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| Indirect pulp capping or management of deep caries lesions, or Direct pulp capping | Temporary disinfectant dressings in the obturation of root canals Indirect pulp capping or management of deep caries lesions, or Direct pulp capping | Temporary root filling Root canal filling for primary teeth Vital pulpotomy Temporary pulp capping | |
|---|---|---|---|
| Device Description | Calcigel is a creamy, ready -to -use calcium hydroxide paste with a pH above 11. | Cleanical is a pre-filled syringe of calcium hydroxide paste with a pH of 12.3. | Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material. |
| Formula | Calcium hydroxideDemineralized waterBarium sulfatePolyethylene glycol 400Hydroxypropyl methoxycellulose | Calcium hydroxideZirconium dioxideExcipients (n-Methyl-2-pyrrolidone,Hypromellose) | Calcium hydroxideWaterCalcium carbonateZinc oxideBarium SulfatePolyethylene glycol 400Polysorbate (Tween 80) |
| Calcium Hydroxide % | 30% | 30% | 22-26% |
| Mechanism of Action | Paste to be sealed over with a cured cavity liner. | Paste to be sealed over with a cured cavity liner. | Paste to be sealed over with a cured cavity liner. |
| pH | 11-13 | 12.3 | 12.5 |
| Package | Pre-filled syringe | Pre-filled syringe | Pre-filled syringe |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Shelf Life | 3 years | 2 years | 3 years |
| Name | CalUltra (subject device) | Life Regular Set/Life Fast Set(Additional predicate device)) | Adseal (reference device for ingredients) | VLC Dycal II (reference device for ingredients) | CFR | 872.3250 | 872.3250 | 872.3820 | 872.3250 |
|---|---|---|---|---|---|---|---|---|---|
| 510k Number | K212475 | K150559 | K042769 | K922721 | Indications for Use | CalUltra is ahard-settingcalciumhydroxide cavityliner and pulpcapping agentto be used inconjunctionwith allpermanentrestorativetechniques. | Life is a hard-setting calciumhydroxide cavityliner and pulpcapping agent tobe used inconjunction withall permanentrestorativetechniques. | Adseal is abiocompatibleroot canal sealerfor permanentsealing of rootcanals followingestablishedendodonticprocedures andmay be used inconjunction withthe auxiliarymaterials in theroot canal (i.e.guttapercha points)Adseal is intendedfor use byqualifiedhealthcarepersonnel trainedin its use. | 1. Application toexposed, vital pulptissue (direct pulpcapping).2. Application todentin as aprotective barrierbetween restorativematerials anddeep vital dentin(indirect pulpcapping) or wheredentin to restorativematerial contact isnot desired. |
| Common Name | Cavity linerand/or basematerial | Cavity liner and/orbase material | Root canal sealer | Cavity liner | DeviceDescription | CalUltra is ahard-settingcalciumhydroxide cavityliner and pulpcapping agent.CalUltra is atwo-partbase/catalystpaste/pastesystem. | Life is a hard-setting calciumhydroxide cavityliner and pulpcapping agent. Lifeis a two-partbase/catalystpaste/pastesystem. | Adseal root canalsealer is a twocomponentpaste:pastedevice basedupon epoxy-amine resinchemistry. Thissealer is easy tomix and adaptsclosely to thewalls of theprepared rootcanaland providesoutstanding long-term dimensionalstability withminimalshrinkage uponsetting.The deviceconsists of twocomponents the | Dycal® CalciumHydroxide Liner is atwo-component,rigid-setting, self-curingmaterial designedfor use in direct andindirect pulpcapping and as aprotectiveliner under dentaladhesives,varnishes, fillingmaterials, cements,and otherbase materials. Itwill not inhibit thepolymerization ofacrylic andcompositerestorations. |
| Classification Name | Calcium hydroxide cavityliner | Calcium hydroxidecavity liner | Root canal fillingresin | Calcium hydroxidecavity liner | |||||
| Class | II | II | II | II | |||||
| Product Code | EJK | EJK | KIF | EJK |
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| Formula | ||||
|---|---|---|---|---|
| Base: | Base: | Base: disalicylate | ||
| Calcium | Calcium | epoxy resin paste(Paste A) and theamine containingpaste (Paste B);portions of whichare mixed priorto insertion intothe root canal.This twocomponentsystem reacts viaan epoxide-amine chemicalreaction to causesetting. Itmay be used inconjunction withthe auxiliarymaterials in theroot canal (i.e.gutta perchapoints).Paste A andPaste B arecontained,separately, withthe chambers of atwo componentplasticsyringe,packaged with adisposableapplicator. | ester of 1,3 | |
| hydroxide, | dihydroxide, | Paste A: | butylene glycol, | |
| Ethylene | Zinc oxide, calcium | Ethylene glycolsalicylate | calcium phosphate, | |
| toluene | oxide, ethylene | Bismuthsubcarbonate | calcium tungstate, | |
| sulfonamide, | toluene | Epoxy oligomerresin | zinc oxide, iron | |
| Zinc oxide,Zinc stearate | sulfonamide | oxide | ||
| Catalyst: calcium | ||||
| Catalyst: | Paste B: | |||
| Catalyst:Ethylene glycolsalicylate, | Methyl salicylate,2,2dimethylpropane -1,3 diol, | Polybutanediolaminobenzoate,Calcium phosphateBismuthsubcarbonate | hydroxide, ethyltoluenesulfonamide,zinc stearate,titanium dioxide, | |
| Tricalciumphosphate | Fumed silica | |||
| Zinc oxide,Barium sulfate,zinc stearate,fumed silica,pigments | zinc oxide, ironoxide | |||
| Mechanism of Action | Set bybase/catalystreaction | Set bybase/catalystreaction | Set bybase/catalystreaction | Set by base/catalystreaction |
| Setting Time | 1-3 minutes | Unknown | 70 minutes | 2-3 minutes |
| Water solubility | 3.8% | Unknown | 0.24% | Unknown |
| pH | 9.2 | Unknown | 9.06 | Unknown |
| Package | Tubes | Tubes | dual syringe | Tubes |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Shelf Life | 3 years | Unknown | Unknown | Unknown |
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Conclusion: Prevest Denpro Cavity Liners are substantially equivalent to the predicate device, Cleanical. They have the same indications, same mechanism of action, 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 including Cavios K111668 which also has a 3 year shelf life. Reference devices are included to cover any ingredients, or indications not covered by the predicate devices. Any differences in ingredients are minor and do not change the substantial equivalence.
§ 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.