Predicate Devices

CleaniCal K201799, Ultra Blend Plus K970113, Life Regular Set/ Life Fast Set K150559

Reference Devices

K111668, K123265, K190091, K042769, K922721

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and chemical properties of dental materials, with no mention of AI or ML.

Therapeutic

Yes
The devices are used for indirect and direct pulp capping, which are therapeutic procedures aimed at preserving pulp vitality and promoting healing in teeth with deep caries lesions or pulp exposures.

Diagnostic

No

These devices are materials used for dental procedures like cavity lining and pulp capping, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states that the devices are physical materials (pastes and a two-part system) sold in syringes or tubes with accompanying applicator tips, spatulas, and mixing pads. These are hardware components, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, none of these devices are IVDs (In Vitro Diagnostics).

Here's why:

IVDs are used to examine specimens derived from the human body. The intended use and device descriptions clearly indicate that these products are applied directly to the patient's teeth and surrounding structures (cavities, pulp, dentin, root canals). They are not used to test samples taken from the body.
The performance studies focus on physical and chemical properties of the materials themselves, such as strength, cure depth, solubility, flow, and pH. They do not involve testing biological samples or measuring biological markers.
The anatomical sites mentioned are within the patient's mouth, not laboratory settings where IVD testing typically occurs.

These devices are dental materials used for restorative and therapeutic purposes within the patient's mouth, not for diagnostic testing of biological specimens.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

EJK

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

CleaniCal K201799, Ultra Blend Plus K970113, Life Regular Set/ Life Fast Set K150559

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.

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

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

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the 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

1

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

2

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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.

4

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

5

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
device) | CleaniCal (predicate
device) | Cavios Calcium
Hydroxide Cavity Liner
(reference device for
ingredients) |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k Number | K212475 | K201799 | K111668 |
| Common Name | Cavity Liner | Calcium Hydroxide
Paste | Cavity Liner |
| Classification Name | Calcium Hydroxide
Cavity Liner | Calcium Hydroxide
Cavity Liner | Calcium Hydroxide
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
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 | Cleanical is a calcium
hydroxide paste that
has a creamy
consistency and is
suitable for several
indications including:
Temporary
disinfectant
dressings in the
obturation of
root canals Indirect pulp
capping or
management
of deep caries
lesions or | Cavios cavity Liner is to
be applied to the
interior of a prepared
cavity prior to the
insertion of restorative
materials. Cavios Cavity
Liner is indicated for
use in the general
dental population. |

Cavity Liners from Prevest Denpro

6

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

7

| | It is self-adhering and
highly filled. | self-adhering and
highly filled. | dental professionals as
a liner, base, or luting
material in dental
restorations. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | CAL-LC is a highly filled
cavity liner and pulp
capping material. | Ultra Blend Plus is a
highly filled cavity liner
and pulp capping
material. | Pulpdent RGMI Low
Viscosity is a resin-
modified glass ionomer
in two pastes. |
| Formula | diurethane
dimethyacrylate,
Barium sulfate, calcium
hydroxide,
Silanated barium glass
powder,
Amorphous fumed
silica,
Photo initiators, and
stablizers | Diurethane
dimethacrylate, barium
sulfate, calcium
hydroxide, calcium
hydroxyapatite,
triethylene glycol
dimethacrylate, amine
methacrylate | Part A:
Diurethane
dimethacrylate,
polyacrylic acid/maleic
acid copolymer, water,
barium borosilicate
glass, silica, reducing
agents, photo initiators
Part B: Diurethane
dimethacrylate,
aluminofluorosilicate
ionomer 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

8

	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
Demineralized water
Barium sulfate
Polyethylene glycol 400
Hydroxypropyl methoxycellulose	Calcium hydroxide
Zirconium dioxide
Excipients (n-Methyl-2-pyrrolidone,
Hypromellose)	Calcium hydroxide
Water
Calcium carbonate
Zinc oxide
Barium Sulfate
Polyethylene glycol 400
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/
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 a
hard-setting
calcium
hydroxide cavity
liner and pulp
capping agent
to be used in
conjunction
with all
permanent
restorative
techniques. | Life is a hard-
setting calcium
hydroxide cavity
liner and pulp
capping agent to
be used in
conjunction with
all permanent
restorative
techniques. | Adseal is a
biocompatible
root canal sealer
for permanent
sealing of root
canals following
established
endodontic
procedures and
may be used in
conjunction with
the auxiliary
materials in the
root canal (i.e.
gutta
percha points)
Adseal is intended
for use by
qualified
healthcare
personnel trained
in its use. | 1. Application to
exposed, vital pulp
tissue (direct pulp
capping).
2. Application to
dentin as a
protective barrier
between restorative
materials and
deep vital dentin
(indirect pulp
capping) or where
dentin to restorative
material contact is
not desired. |
| Common Name | Cavity liner
and/or base
material | Cavity liner and/or
base material | Root canal sealer | Cavity liner | Device
Description | CalUltra is a
hard-setting
calcium
hydroxide cavity
liner and pulp
capping agent.
CalUltra is a
two-part
base/catalyst
paste/paste
system. | Life is a hard-
setting calcium
hydroxide cavity
liner and pulp
capping agent. Life
is a two-part
base/catalyst
paste/paste
system. | Adseal root canal
sealer is a two
component
paste:paste
device based
upon epoxy-
amine resin
chemistry. This
sealer is easy to
mix and adapts
closely to the
walls of the
prepared root
canal
and provides
outstanding long-
term dimensional
stability with
minimal
shrinkage upon
setting.
The device
consists of two
components the | Dycal® Calcium
Hydroxide Liner is a
two-component,
rigid-setting, self-
curing
material designed
for use in direct and
indirect pulp
capping and as a
protective
liner under dental
adhesives,
varnishes, filling
materials, cements,
and other
base materials. It
will not inhibit the
polymerization of
acrylic and
composite
restorations. |
| Classification Name | Calcium hydroxide cavity
liner | Calcium hydroxide
cavity liner | Root canal filling
resin | Calcium hydroxide
cavity liner | | | | | |
| Class | II | II | II | II | | | | | |
| Product Code | EJK | EJK | KIF | EJK | | | | | |

9

10

Formula
	Base:	Base:		Base: disalicylate
	Calcium	Calcium	epoxy resin paste
(Paste A) and the
amine containing
paste (Paste B);
portions of which
are mixed prior
to insertion into
the root canal.
This two
component
system reacts via
an epoxide-
amine chemical
reaction to cause
setting. It
may be used in
conjunction with
the auxiliary
materials in the
root canal (i.e.
gutta percha
points).
Paste A and
Paste B are
contained,
separately, with
the chambers of a
two component
plastic
syringe,
packaged with a
disposable
applicator.	ester of 1,3
	hydroxide,	dihydroxide,	Paste A:	butylene glycol,
	Ethylene	Zinc oxide, calcium	Ethylene glycol
salicylate	calcium phosphate,
	toluene	oxide, ethylene	Bismuth
subcarbonate	calcium tungstate,
	sulfonamide,	toluene	Epoxy oligomer
resin	zinc oxide, iron
	Zinc oxide,
Zinc stearate	sulfonamide		oxide
				Catalyst: calcium
		Catalyst:	Paste B:
	Catalyst:
Ethylene glycol
salicylate,	Methyl salicylate,
2,2
dimethylpropane -
1,3 diol,	Polybutanediol
aminobenzoate,
Calcium phosphate
Bismuth
subcarbonate	hydroxide, ethyl
toluenesulfonamide,
zinc stearate,
titanium dioxide,
	Tricalcium
phosphate	Fumed silica
	Zinc oxide,
Barium sulfate,
zinc stearate,
fumed silica,
pigments			zinc oxide, iron
oxide
Mechanism of Action	Set by
base/catalyst
reaction	Set by
base/catalyst
reaction	Set by
base/catalyst
reaction	Set by base/catalyst
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

11

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.