Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)

K212475 · Prevest Denpro Limited · EJK · May 13, 2022 · Dental

Device Facts

• Record ID: K212475
• Device Name: Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
• Applicant: Prevest Denpro Limited
• Product Code: EJK · Dental
• Decision Date: May 13, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) are dental materials used for cavity lining and pulp capping. Apacal ART and Cal LC are light-cured, single-component pastes; Calcigel is a ready-to-use calcium hydroxide paste; CalUltra is a two-part base/catalyst paste system. Devices are applied by dental professionals in a clinical setting to prepared cavities or exposed pulp. Apacal ART and Cal LC utilize light-curing mechanisms; Calcigel is sealed with a restorative material; CalUltra sets via a base/catalyst chemical reaction. These liners act as protective barriers between restorative materials and dentin/pulp, aiding in pulp management and restorative success. Benefits include protection of vital pulp tissue and improved clinical outcomes for permanent restorations.

Clinical Evidence

Bench testing only. Devices were evaluated for appearance, flexural strength, depth of cure, water sorption/solubility, radio-opacity, flow, pH, and setting time per ISO 9917-1/2, ISO 4049, ISO 13116, ISO 6876, and USP 971. Shelf life testing confirmed a 3-year duration. All results met established criteria.

Technological Characteristics

Materials include calcium hydroxide, tricalcium phosphate, hydroxyapatite, barium sulfate, and resin matrices (e.g., UDMA, TEGDMA). Sensing/actuation: chemical setting (base/catalyst) or light-curing (photo-initiators). Form factors: pre-filled syringes or two-part paste tubes. Connectivity: none. Sterilization: non-sterile.

Indications for Use

Indicated for dental patients requiring cavity lining or pulp capping (direct or indirect) and management of deep caries lesions. Used in conjunction with permanent restorative techniques.

Regulatory Classification

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.

Predicate Devices

• CleaniCal (K201799)
• Ultra Blend Plus (K970113)
• Life Regular Set/ Life Fast Set (K150559)

Reference Devices

• Cavios Calcium Hydroxide Cavity Liner (K111668)
• RMGI Low Viscosity (K123265)
• DIAPASTE (K190091)
• Adseal (K042769)
• VLC Dycal II (K922721)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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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: [e-mail] Telephone: [phone]

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 [phone] [e-mail]

#### 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:<br>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:<br>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 (subject<br>device) | CleaniCal (predicate<br>device) | Cavios Calcium<br>Hydroxide Cavity Liner<br>(reference device for<br>ingredients) |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k Number | K212475 | K201799 | K111668 |
| Common Name | Cavity Liner | Calcium Hydroxide<br>Paste | Cavity Liner |
| Classification Name | Calcium Hydroxide<br>Cavity Liner | Calcium Hydroxide<br>Cavity Liner | Calcium Hydroxide<br>Cavity Liner |
| Class | II | II | II |
| Product Code | EJK | EJK, KIF | EJK |
| CFR | 872.3250 | 872.3250 | 872.3820 |
| Indications for Use | Apacal ART and is<br>suitable for several<br>indications including:<br>Liner to be<br>applied to the<br>interior of a<br>prepared cavity<br>prior to the<br>insertion of<br>restorative<br>materials. Indirect pulp<br>capping or<br>management<br>of deep caries<br>lesions or | Cleanical is a calcium<br>hydroxide paste that<br>has a creamy<br>consistency and is<br>suitable for several<br>indications including:<br>Temporary<br>disinfectant<br>dressings in the<br>obturation of<br>root canals Indirect pulp<br>capping or<br>management<br>of deep caries<br>lesions or | Cavios cavity Liner is to<br>be applied to the<br>interior of a prepared<br>cavity prior to the<br>insertion of restorative<br>materials. Cavios Cavity<br>Liner is indicated for<br>use in the general<br>dental population. |

#### Cavity Liners from Prevest Denpro

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| | • Direct pulp capping | • Direct pulp capping | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Device Description | Apacal ART is a light<br>cured single-<br>component paste<br>reinforced with<br>tricalcium phosphate<br>and hydroxyapatite. | Cleanical is a pre-filled<br>syringe of calcium<br>hydroxide paste with a<br>pH of 12.3. | Cavios is a light cured<br>single-component<br>yellow-white paste for<br>use as a dentin liner<br>and paste. |
| Formula | urethane<br>dimethyacrylate,<br>triethylene glycol<br>dimethacrylate,<br>barium sulfate,<br>silanated barium glass<br>powder,<br>amorphous fumed<br>silica,<br>tricalcium phosphate,<br>hydroxyapatite,<br>calcium hydroxide,<br>photo initiators, and<br>stablizers | Calcium hydroxide<br>Zirconium dioxide<br>Excipients (n-Methyl-2-<br>pyrrolidone,<br>Hypromellose) | Urethane<br>dimethacrylate,<br>Tricalcium phosphate<br>Barium sulfate, photo<br>initiator |
| 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<br>(additional predicate<br>device) | RMGI Low Viscosity<br>(reference device for<br>ingredients) |
|---------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| 510k Number | K212475 | K970113 | K123265 |
| Common Name | Cavity liner and/or<br>base material | Cavity liner and/or<br>base material | Dental cement, cavity<br>liner |
| Classification Name | Calcium hydroxide<br>cavity liner | Calcium hydroxide<br>cavity liner | Dental cement, cavity<br>liner |
| Class | II | II | II |
| Product Code | EJK | EJK | EMA, EJK |
| CFR | 872.3250 | 872.3250 | 872.3275 |
| Indications for Use | CAL-LC is indicated for<br>use as a cavity liner and<br>pulp capping material. | Ultra Blend Plus is<br>indicated for use as a<br>cavity liner and pulp<br>capping material. It is | Pulpdent RMGI Low<br>Viscosity is a resin-<br>modified glass ionomer<br>preparation used by |

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| | It is self-adhering and<br>highly filled. | self-adhering and<br>highly filled. | dental professionals as<br>a liner, base, or luting<br>material in dental<br>restorations. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | CAL-LC is a highly filled<br>cavity liner and pulp<br>capping material. | Ultra Blend Plus is a<br>highly filled cavity liner<br>and pulp capping<br>material. | Pulpdent RGMI Low<br>Viscosity is a resin-<br>modified glass ionomer<br>in two pastes. |
| Formula | diurethane<br>dimethyacrylate,<br>Barium sulfate, calcium<br>hydroxide,<br>Silanated barium glass<br>powder,<br>Amorphous fumed<br>silica,<br>Photo initiators, and<br>stablizers | Diurethane<br>dimethacrylate, barium<br>sulfate, calcium<br>hydroxide, calcium<br>hydroxyapatite,<br>triethylene glycol<br>dimethacrylate, amine<br>methacrylate | Part A:<br>Diurethane<br>dimethacrylate,<br>polyacrylic acid/maleic<br>acid copolymer, water,<br>barium borosilicate<br>glass, silica, reducing<br>agents, photo initiators<br>Part B: Diurethane<br>dimethacrylate,<br>aluminofluorosilicate<br>ionomer glass, silica,<br>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:<br>• 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 hydroxide<br>Demineralized water<br>Barium sulfate<br>Polyethylene glycol 400<br>Hydroxypropyl methoxycellulose | Calcium hydroxide<br>Zirconium dioxide<br>Excipients (n-Methyl-2-pyrrolidone,<br>Hypromellose) | Calcium hydroxide<br>Water<br>Calcium carbonate<br>Zinc oxide<br>Barium Sulfate<br>Polyethylene glycol 400<br>Polysorbate (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/<br>Life Fast Set<br>(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 a<br>hard-setting<br>calcium<br>hydroxide cavity<br>liner and pulp<br>capping agent<br>to be used in<br>conjunction<br>with all<br>permanent<br>restorative<br>techniques. | Life is a hard-<br>setting calcium<br>hydroxide cavity<br>liner and pulp<br>capping agent to<br>be used in<br>conjunction with<br>all permanent<br>restorative<br>techniques. | Adseal is a<br>biocompatible<br>root canal sealer<br>for permanent<br>sealing of root<br>canals following<br>established<br>endodontic<br>procedures and<br>may be used in<br>conjunction with<br>the auxiliary<br>materials in the<br>root canal (i.e.<br>gutta<br>percha points)<br>Adseal is intended<br>for use by<br>qualified<br>healthcare<br>personnel trained<br>in its use. | 1. Application to<br>exposed, vital pulp<br>tissue (direct pulp<br>capping).<br>2. Application to<br>dentin as a<br>protective barrier<br>between restorative<br>materials and<br>deep vital dentin<br>(indirect pulp<br>capping) or where<br>dentin to restorative<br>material contact is<br>not desired. |
| Common Name | Cavity liner<br>and/or base<br>material | Cavity liner and/or<br>base material | Root canal sealer | Cavity liner | Device<br>Description | CalUltra is a<br>hard-setting<br>calcium<br>hydroxide cavity<br>liner and pulp<br>capping agent.<br>CalUltra is a<br>two-part<br>base/catalyst<br>paste/paste<br>system. | Life is a hard-<br>setting calcium<br>hydroxide cavity<br>liner and pulp<br>capping agent. Life<br>is a two-part<br>base/catalyst<br>paste/paste<br>system. | Adseal root canal<br>sealer is a two<br>component<br>paste:paste<br>device based<br>upon epoxy-<br>amine resin<br>chemistry. This<br>sealer is easy to<br>mix and adapts<br>closely to the<br>walls of the<br>prepared root<br>canal<br>and provides<br>outstanding long-<br>term dimensional<br>stability with<br>minimal<br>shrinkage upon<br>setting.<br>The device<br>consists of two<br>components the | Dycal® Calcium<br>Hydroxide Liner is a<br>two-component,<br>rigid-setting, self-<br>curing<br>material designed<br>for use in direct and<br>indirect pulp<br>capping and as a<br>protective<br>liner under dental<br>adhesives,<br>varnishes, filling<br>materials, cements,<br>and other<br>base materials. It<br>will not inhibit the<br>polymerization of<br>acrylic and<br>composite<br>restorations. |
| Classification Name | Calcium hydroxide cavity<br>liner | Calcium hydroxide<br>cavity liner | Root canal filling<br>resin | Calcium hydroxide<br>cavity 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<br>(Paste A) and the<br>amine containing<br>paste (Paste B);<br>portions of which<br>are mixed prior<br>to insertion into<br>the root canal.<br>This two<br>component<br>system reacts via<br>an epoxide-<br>amine chemical<br>reaction to cause<br>setting. It<br>may be used in<br>conjunction with<br>the auxiliary<br>materials in the<br>root canal (i.e.<br>gutta percha<br>points).<br>Paste A and<br>Paste B are<br>contained,<br>separately, with<br>the chambers of a<br>two component<br>plastic<br>syringe,<br>packaged with a<br>disposable<br>applicator. | ester of 1,3 |
| | hydroxide, | dihydroxide, | Paste A: | butylene glycol, |
| | Ethylene | Zinc oxide, calcium | Ethylene glycol<br>salicylate | calcium phosphate, |
| | toluene | oxide, ethylene | Bismuth<br>subcarbonate | calcium tungstate, |
| | sulfonamide, | toluene | Epoxy oligomer<br>resin | zinc oxide, iron |
| | Zinc oxide,<br>Zinc stearate | sulfonamide | | oxide |
| | | | | Catalyst: calcium |
| | | Catalyst: | Paste B: | |
| | Catalyst:<br>Ethylene glycol<br>salicylate, | Methyl salicylate,<br>2,2<br>dimethylpropane -<br>1,3 diol, | Polybutanediol<br>aminobenzoate,<br>Calcium phosphate<br>Bismuth<br>subcarbonate | hydroxide, ethyl<br>toluenesulfonamide,<br>zinc stearate,<br>titanium dioxide, |
| | Tricalcium<br>phosphate | Fumed silica | | |
| | Zinc oxide,<br>Barium sulfate,<br>zinc stearate,<br>fumed silica,<br>pigments | | | zinc oxide, iron<br>oxide |
| Mechanism of Action | Set by<br>base/catalyst<br>reaction | Set by<br>base/catalyst<br>reaction | Set by<br>base/catalyst<br>reaction | Set by base/catalyst<br>reaction |
| 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.