(283 days)
No
The device descriptions and performance studies focus on the physical and chemical properties of root canal filling materials, with no mention of AI or ML.
No
Explanation: These devices are root canal filling and sealing materials, which are used to fill physical spaces in the tooth after treatment. They do not directly treat a disease or condition.
No.
The devices described are root canal filling and sealing materials, which are used for treatment (obturating the root canal space) rather than for diagnosing a condition or disease.
No
The device descriptions clearly indicate that these are physical materials (pastes, powders, liquids) used for filling root canals, not software.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use of all listed devices is for filling or sealing root canals in the context of dental procedures. This is a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The descriptions detail the composition and physical properties of materials used for filling root canals. They do not describe any components or functions related to analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on physical and chemical properties relevant to their function as root canal filling materials (flow, setting time, radiopacity, etc.) and biocompatibility. They do not involve evaluating the device's ability to detect or measure any biological markers or conditions.
- Anatomical Site: The anatomical site is the root canal, which is a part of the tooth being treated, not a source of biological samples for diagnostic testing.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The devices described here are materials used within the body for a therapeutic purpose.
N/A
Intended Use / Indications for Use
CalApex is a calcium hydroxide, polymeric resin, root canal filling material that is used in conjunction with gutta percha or silver endodontic points.
Calplus is a temporary or permanent root canal filling material for use following pulpectomy, or for apexogenesis or apexification.
Cerafill RCS is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials.
Endoseal is used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials.
Nanoseal S is indicated in patients for permanent obturations of root canal after vital extirpation or after treatment of pulpal gangrene and temporary filling.
Zical Ultra Paste is used for permanent obturation of the root canal space with the aid of obturating pounts.
Zical Powder/Liquid is used for permanent obturation of the root canal space with the aid of obturating points.
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
CalApex is a non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material. It is a two part, base/catalyst – paste/paste system that is mixed in equal portions. The mixture is then carried to the root canal with endodontic obturation points or directly dispensed in the root canal depending on delivery method, e.g. tube or dual-barrel syringe.
Calplus can be used as a temporary or permanent root canal filling material.
Cerafill RCS is an endodontic sealer based on MTA, providing a biocompatible and effective root canal filling. It is premixed and pre-loaded in a syringe, which allows a complete filling of the entire root canal including accessory and lateral canals. The product is eugenol-free and will not impede adhesion inside the root canal.
Endoseal is a Zinc Oxide/Eugenol root canal sealant. The product is made up of two separate components, a powder base and a liquid catalyst, to form the final device.
Nanoseal S is a permanent root canal filling material which is silicone based (polydimethylsiloxane). It is cold flowable and is in a dual barrel cartridge.
Zical Ultra Paste is a two-part, base/accelerator, paste/paste system that is mixed in equal portions. The mixture is carried to the root canal with endodontic obturation points. The product comes in a dual barrel cartridge.
Zical Ultra Powder/Liquid is a two-part, powder/liquid system for permanent filling of root canals. The mixture is carried to the root canal with endodontic obturation points.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
CalApex, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, and Zical Ultra (powder/liquid) were tested for appearance, flow, film thickness, water solubility, working time, and disintegration according to protocols based on ISO 6876:2012 and tested for radio-opacity according to a protocol based on ISO 13116:2014. CalPlus was tested for appearance, flow and film thickness according to ISO 6876:2012, and radio-opacity according to ISO 13116: 2014.
All test results passed and the test method pass criteria in standards. Shelf life for the root canal sealers is 3 years except for CalApex which is 2 years. Shelf life uses the same testing protocols as the characterization testing which are based on ISO 6876:2012. Pass criteria are the same as for bench testing. A biocompatibility assessment according to ISO 10993 was provided for all subject devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Appearance: pass/fail criteria set for each device based on acceptable appearance of each paste, base or catalyst.
Flow: CalApex, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, and Zical Ultra (powder/liquid) pass criteria not less than 17mm. CalPlus pass criteria 25-28mm.
Film thickness: not more than 50µm for all subject root canal sealers.
Water solubility: not more than 3% by mass for all subject root canal sealers.
Working time: CalAPex pass criteria 16-18min. Cerafill RCS, Endoseal, Zical Ultra Paste, and Zical Ultra (powder/liquid) pass criteria 25-30min. Nanoseal S pass criteria 8-10min.
Setting time: CalApex pass criteria 20-40min. Cerafill RCS pass criteria 24 hours. Endoseal, Zical Ultra Paste, and Zical Ultra (powder/liquid) pass criteria 45-60min. Nanoseal S pass criteria 10-15min.
Disintegration: no evidence of disintegration for all subject root canal sealers.
Radiopacity: above or equal to 3 mm when compared with aluminum wedge for all subject root canal sealers.
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.
Sealapex K152959, Vitapex K973667, Endoseal MTA K170175, Pulp Canal Sealer K152956, Roeko Seal Root Canal Sealer K983037, Tubliseal K153067
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.
Apexit K893794, Adseal K042769, Theracal K063237, MTA Fillapex K140247, Dia-Root Bio K200175, GuttaSil K190510
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
May 23, 2022
Prevest Denpro Limited % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172
Re: K212563
Trade/Device Name: CalApex, Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: February 15, 2022 Received: February 28, 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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212563
Device Name
Prevest Denpro Root Canal Sealers - Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/ Liquid
Indications for Use (Describe)
CalApex is a calcium hydroxide, polymeric resin, root canal filling material that is used in conjunction with gutta percha or silver endodontic points.
Calplus is a temporary or permanent root canal filling material for use following pulpectorny, or for apexogenesss or apexification.
Cerafill RCS is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials.
Endoseal is used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials.
Nanoseal S is indicated in patients for permanent obturations of root canal after vital extirpation or after treatment of pulpal gangrene and temporary filling.
Zical Ultra Paste is used for permanent obturation of the root canal space with the aid of obturating pounts.
Zical Ultra Powder/Liquid is used for permanent obturation of the root canal space with the aid of obturating points.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CER 801 Subpart D) | ☐ Over-The-Counter Use (21 CER 801 Subpart C) |
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3
Prevest DenPro Root Canal Sealers (Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid) 510K Summary K212563 May 18, 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 Root Canal Sealers (CalApex, Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid) Classification Name: root canal sealer CFR: 21 CFR 872.3820 Primary Product Code: KIF
Submission Contact:
Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 (704)450-9934 angela@blackwelldevice.com
Device Description:
CalApex is a non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material. It is a two part, base/catalyst – paste/paste system that is mixed in equal portions. The mixture is then carried to the root canal with endodontic obturation points or directly dispensed in the root canal depending on delivery method, e.g. tube or dual-barrel syringe.
Calplus can be used as a temporary or permanent root canal filling material.
Cerafill RCS is an endodontic sealer based on MTA, providing a biocompatible and effective root canal filling. It is premixed and pre-loaded in a syringe, which allows a complete filling of the entire root canal including accessory and lateral canals. The product is eugenol-free and will not impede adhesion inside the root canal.
Endoseal is a Zinc Oxide/Eugenol root canal sealant. The product is made up of two separate components, a powder base and a liquid catalyst, to form the final device.
4
Nanoseal S is a permanent root canal filling material which is silicone based (polydimethylsiloxane). It is cold flowable and is in a dual barrel cartridge.
Zical Ultra Paste is a two-part, base/accelerator, paste/paste system that is mixed in equal portions. The mixture is carried to the root canal with endodontic obturation points. The product comes in a dual barrel cartridge.
Zical Ultra Powder/Liquid is a two-part, powder/liquid system for permanent filling of root canals. The mixture is carried to the root canal with endodontic obturation points.
| Device Name | Indications |
|---|---|
| CalApex | CalApex is a calcium hydroxide, polymeric resin, root canal filling material that is used in conjunction with gutta percha or silver endodontic points. |
| Calplus | Calplus is a temporary or permanent root canal filling material for use following pulpectomy, or for apexogenesis or apexification. |
| Cerafill RCS | Cerafill RCS is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials. |
| Endoseal | Endoseal is used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials. |
| Nanoseal S | Nanoseal S is indicated in patients for permanent obturations of root canal after vital extirpation or after treatment of pulpal gangrene and temporary filling. |
| Zical Ultra Paste | Zical Ultra Paste is used for permanent obturation of the root canal space with the aid of obturating points. |
| Zical Ultra Powder/Liquid | Zical Ultra Powder/Liquid is used for permanent obturation of the root canal space with the aid of obturating points. |
Indications for Use:
Testing Summary:
CalApex, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, and Zical Ultra (powder/liquid) were tested for appearance, flow, film thickness, water solubility, working time, and disintegration according to protocols based on ISO 6876:2012 and tested for radio-opacity according to a protocol based on ISO 13116:2014. CalPlus was tested for appearance, flow and film thickness according to ISO 6876:2012, and radio-opacity according to ISO 13116: 2014.
5
Appearance uses a pass/fail criteria set for each device based on the acceptable appearance of each paste, base or catalyst.
Flow test method is based on Section 5.2 of ISO 6876:2012. The CalApex, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, and Zical Ultra (powder/liquid) pass criteria is not less than 17mm. The CalPlus pass criteria is 25-28mm.
Film thickness is based on Section 5.5 of ISO 6876:2012. The pass criteria for all subject root canal sealers is not more than 50µm.
Water solubility is based on Section 5.6 of ISO 6876:2012. The pass criteria for all subject root canal sealers is shall not be more than 3% by mass.
Working time is based on Section 5.3 of ISO 6876:2012. The CalAPex pass criteria is 16-18min. The Cerafill RCS, Endoseal, Zical Ultra Paste, and Zical Ultra (powder/liquid) pass criteria is 25-30min. The Nanoseal S pass criteria is 8-10min.
Setting time is based on Section 5.4 of ISO 6876:2012. The CalApex pass criteria is 20-40min. The Cerafill RCS pass criteria is 24 hours. The Endoseal, Zical Ultra Paste, and Zical Ultra (powder/liquid) pass criteria is 45-60min. The Nanoseal S pass criteria is 10-15min.
Disintegration is based on Section 4.3.5 of ISO 6876:2012. The pass criteria for all subject root canal sealers is no evidence of disintegration.
Radio-opacity is based on ISO 13116:2014. The pass criteria for all subject root canal sealers is above or equal to 3 mm when compared with aluminum wedge.
All test results passed and the test method pass criteria in standards. All test reports are included. The bench testing is the same type of test done by the predicate and reference devices. The pass criteria are either the same as the predicate and reference devices (in some cases ISO 6876 sets pass criteria for all root canal sealers) or the pass criteria are tighter than those of the predicate and reference devices. Having a tighter pass criteria would not change the substantial equivalence because the subject devices would also still meet the pass criteria used by the predicate and reference devices.
Shelf life for the root canal sealers is 3 years except for CalApex which is 2 years. Shelf life uses the same testing protocols as the characterization testing which are based on ISO 6876:2012. Pass criteria are the same as for bench testing. The predicate and reference devices use the same ISO standard for their testing but have unknown shelf lives in most cases (Sealapex and MTA Fillapex have a 2 year shelf life).
A biocompatibility assessment according to ISO 10993 was provided for all subject devices.
Predicate Devices: Sealapex K152959, Vitapex K973667, Endoseal MTA K170175, Pulp Canal Sealer K152956, Roeko Seal Root Canal Sealer K983037, Tubliseal K153067
Reference Devices: Apexit K893794 (ingredients), Adseal K042769 (ingedients), Theracal K063237 (ingredients), MTA Fillapex K140247 (ingredients), Dia-Root Bio K200175 (ingredients), GuttaSil K190510 (ingredients)
Substantial Equivalence:
6
The root canal sealers have similar ingredients to the predicate and reference devices, the same indications for use, and similar physical parameter testing.
Root Canal Sealers from Prevest Denpro
| | CalApex
K212563
Subject
Device | Sealapex
K152959
Predicate
Device | Apexit
K893794
Reference
Device | Adseal
K042769
Reference
Device | Theracal
K063237
Reference
Device | MTA
Fillapex
K140247
Reference
Device |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
Code | KIF | KIF | KIF | KIF | EJK | KIF |
| Indications
for Use | CalApex is a
calcium
hydroxide,
polymeric
resin, root
canal filling
material
that is used
in
conjunction
with gutta
percha or
silver
endodontic
points. | Sealapex/
Sealapex
Xpress is a
calcium
hydroxide,
polymeric
resin, root
canal filling
material
that is used
in
conjunction
with gutta
percha or
silver
endodontic
points. | —
Permanent
obturation
following
vital pulp
extirpation
—
Permanent
obturation
following
the removal
of a
gangrenous
pulp and
placement
of intracanal
disinfectant
dressings
—
Permanent
obturation
in cases
with
external and
internal
root
resorption
Apexit Plus
is suitable
for use in
the single
cone and
lateral
condensatio
n technique,
as well as in | 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. Liner
2. Pulp
capping
agent | MTA-
Fillapex is a
root canal
sealer
intended
for the
permanent
scaling of
root canals
and may
be used in
combinatio
n with root
canal
obturation
materials. |
| Device | | | | | | |
| Description | CalApex is a | Sealapex/S
ealapex
Xpress is a | Apexit is an | Adseal root
canal sealer is | TheraCal is a | MTA
Fillapex is a |
| | non-
eugenol,
radiopaque,
calcium
hydroxide
polymeric
resin root
canal filling
material.
It is a two
part,
base/catalyst –
paste/paste
system that
is mixed in
equal
portions.
The mixture
is then
carried to
the root
canal with
endodontic
obturation
points or
directly
dispensed
in the
root canal
depending
on delivery
method,
e.g. tube or
dual-barrel
syringe. | non-
eugenol,
radiopaque
, calcium
hydroxide
polymeric
resin root
canal filling
material. It
is indicated
for use as a
root canal
sealing and
filling
material,
and is used
during an
endodontic
procedure
to seal off
the
prepared
root canal
apical
foramen
and tubules
from blood,
exudates,
and
infection.
The
proposed is
a two part,
base/catalyst –
paste/paste system
that is | insoluble,
radiopaque
calcium
hydroxide
cement for
the
permanent
obturation
of root
canals in
combination
with guttapercha
points. It
does not
shrink
during
setting and
demonstrates excellent
physical and
biological
properties.
Apexit is a
two-
component
system.
Base and
activator
are supplied
in doublepush
syringes
with a static
mixing
device.
| a two
component
paste:paste
device based
upon epoxyamine 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
tow
components,
the 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 | light-cured
resin-based,
mineral
trioxide
aggregate
(MTA) filled,
liner
designed to
perform as a
barrier and
to protect
the dental
pulpal
complex.
TheraCal
LC's precise
placement
allows its
use in all
deep cavity
preparations. The lightcured set
permits the
practitioner
immediate
placement
and
condensation
of the
restorative
material. Its
proprietary
formulation
allows for a
command
set with a
visible light
curing unit
while | mineral
ttioxide
aggregate
(MTA) and
resin toot
canal
sealer used
during
endodontic
treatment
to
permanently fill the
canal
system
following
debridement and
disinfection. It
consists of
two
component
pastes that
are
combined
in a dual
barrel
syringe for
ease of
dispensing
and
consistent
dosage.
Being
hydrophilic
in nature,
MTA |
| all
techniques
involving
heat-
softened
gutta-
percha. | | | | | | |
| | | mixed in | | system reacts | maintaining | FILLAPEX is |
| | | equal | | via an | ease of | desirable |
| | | portions. | | epoxide- | placement | as a root |
| | | Then, the | | amine | due to | filling |
| | | mixture | | chemical | thixotropic | material |
| | | is carried to | | reaction to | properties. | because an |
| | | the root | | cause setting. | The | isolated |
| | | canal with | | It may be used | proprietary | dry field is |
| | | endodontic | | in conjunction | hydrophilic | not |
| | | obturation | | with the | resin | necessary |
| | | points or | | auxiliary | formulation | for use. |
| | | directly | | materials in | creates a | Moisture |
| | | dispensed | | the root canal | stable and | does not |
| | | in the | | (i.e. gutta | durable | negatively |
| | | root canal | | percha | liner or | affect the |
| | | depending | | points). Paste | base. | sealing |
| | | on delivery | | A and Paste B | | ability and |
| | | method, | | are contained, | | is required |
| | | e.g. tube or | | separately, | | for proper |
| | | dual-barrel | | within the | | setting. It is |
| | | syringe. | | chambers of a | | used in |
| | | | | two | | combinatio |
| | | | | component | | n ,with |
| | | | | plastic | | gutta- |
| | | | | syringe, | | percha or |
| | | | | packaged with | | silver |
| | | | | a disposable | | points |
| | | | | applicator. | | during root |
| | | | | | | canal |
| | | | | | | obturation. |
| Compositio | Base | Base | Calcium | Base | Portland | Paste A |
| n | n-ethylene | n-ethylene | salts | Epoxy | cement, | Methyl |
| | ortho/para | ortho/para | (hydroxide, | oligomer | polyethylen | Salicylate, |
| | toluene | toluene | oxide, | resin, | e glycol | Butylene |
| | sulfonamid | sulfonamid | phosphate), | ethylene | dimethacryl | Glycol, |
| | e, calcium | e, calcium | hydrogenize | glycol | ate, barium | Colophony, |
| | hydroxide, | hydroxide, | d | salicylate, | zirconate | Calcium |
| | Portland | zinc oxide, | colophony, | bismuth | | Tungstate, |
| | cement, | zinc | disalicylate, | subcarbonate | | Fumed |
| | hydrogenat | stearate | bismuth | | | Silica |
| | ed resin, | | salts (oxide, | Catalyst | | |
| | zinc oxide, | | carbonate), | Polybutanedio | | Paste B |
| | zinc | Catalyst | highly | l, | | Fumed |
| | stearate, | Methyl | dispersed | Aminobenzoat | | silica, |
| | pigment, | salicylate, | silicon | e, | | titanium |
| | inert | isobutyl | dioxide | Calcium | | dioxide, |
| | ingredients | salicylate, | (silanized) | phosphate, | | MTA |
| | | 2,2 | | | | (dicalcium |
7
8
9
| | Catalyst
Ethylene
glycol
salicylate,
butylene
glycol,
tricalcium
phosphate,
silica, zinc
oxide,
bismuth
trioxide,
zinc
stearate,
pigment,
inert
ingredients | dimethylpr
opane -1,3-
diol | and alkyl
ester of
phosphoric
acid. | bismuth
subcarbonate | | silicate,
tricalcium
silicate,
calcium
oxide,
tricalcium
aluminate),
pentaeryth
ritol,
rosinate, p-
toluenesulf
onamide |
|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|----------------------------------------------|-------------------------------------|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Form | Two Pastes
(Base and
Catalyst) | Two Pastes
(Base and
Catalyst) | Two Pastes
(Base and
Catalyst) | Two Pastes
(Expoxy and
Amine) | Light Cured
Paste | Two Pastes
(Base and
Catalyst) |
| Mix Ratio | Equal
Volumes | Equal
Volumes | Equal
Volumes | Equal
Volumes | N/A | Equal
Volumes |
| Film
Thickness
less than
50μm limit
in ISO 6876 | Yes | Yes | | | | Yes |
| Flow
according
to ISO 6876 | >17mm | 22.8mm | | | | 29mm |
| Working
Time | > 60
minutes | > 60
minutes | 3 hours | | | 23 minutes |
| Setting
Time | 3.3mm Al | | | | > 3mm Al |
| Film
thickness,
flow, water
solubility,
working
time, and
disintegrati
on meet
ISO 6876. | Yes | Yes | | Yes | | Yes |
10
| Biocompatibility
Assessment
According
to ISO
| 10993 | Yes | Yes | |||
|---|---|---|---|---|---|
| ---------------------------------------------------------------- | ----- | ----- | -- | -- | -- |
| Calplus K212563 | Vitapex K973667 | |
|---|---|---|
| Subject Device | Predicate Device | |
| Product Code | KIF | KIF |
| Indications for Use | Calplus is a temporary or | |
| permanent root canal filling | ||
| material for use following | ||
| pulpectomy, or for | ||
| apexogenesis or apexification. | A temporary or permanent root | |
| canal filling material for use to | ||
| stimulate the healing process | ||
| due to the mixture of calcium | ||
| hydroxide and iodoform and the | ||
| induction effect of these two | ||
| ingredients. Used to promote | ||
| healing effects and to help | ||
| prevent bacterial contamination | ||
| of the canal, as the two | ||
| ingredients improve the | ||
| induction effect for hard tissue | ||
| induction and deposition. To be | ||
| used as a medicament for the | ||
| treatment of infected root | ||
| canals, and as a permanent, low | ||
| volume additive to the filling | ||
| process of a treated root canal | ||
| to assist in the induction and | ||
| deposition of hard tissue to | ||
| make the healing process more | ||
| rapid and complete. For use in | ||
| the treatment of infected root | ||
| canals, or following pulpectomy, | ||
| or for apexogenesis or | ||
| apexification, and/or for the tip | ||
| filling of prepared, treated root | ||
| canals at the time of final filling | ||
| with gutta-percha. | ||
| Device Description | Calplus can be used as a | |
| temporary or permanent root | ||
| canal filling material. | Vitapex can be used as a | |
| temporary or permanent root | ||
| canal filler material. | ||
| Composition | Iodoform, Calcium hydroxide, | |
| Silicone Oil, inert ingredients | Iodoform, Calcium hydroxide, | |
| Silicone Oil, inert ingredients |
11
| Form | Pre-mixed paste | Pre-mixed |
|---|---|---|
| Flow | 25-28mm | 30mm |
| Film Thickness | 3mm Al | |
| Flow and film thickness meet | ||
| ISO 6876 | Yes | Yes |
| Biocompatibility Assessment | ||
| According to ISO 10993 | Yes | Unknown |
| Product Code | Cerafill RCS
K212563
Subject Device | Endoseal ΜΤΑ
K170175
Predicate Device | DIA-ROOT BIO
sealer K200175
Reference Device |
|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| KIF | KIF | KIF | KIF |
| Indications for
Use | Cerafill RCS is a
MTA (mineral
trioxide
aggregate) based
root canal sealer
that provides
complete and
permanent
sealing of root
canals. It can be
used with or
without root
canal obturation
materials. | • Permanent
obturation of the
root canal
following vital
pulp-extirpation •
Permanent
obturation of the
root canal
following removal
of infected or
necrotic pulp and
placement of
intracanal
dressings. | DIA-ROOT BIO
Sealer is a MTA
(mineral trioxide
aggregate) based
root canal sealer
that provides
complete and
permanent
sealing of root
canals. It can be
used with or
without root
canal obturation
materials. |
| Device
Description | Cerafill RCS is an
endodontic sealer
based on MTA,
providing a
biocompatible
and effective root
canal filling. It is
premixed and pre-
loaded in a
syringe, which
allows a complete
filling of the
entire root canal
including
accessory and
lateral canals. The
product is
eugenol-free and
will not impede | ENDOSEAL MTA is
an endodontic
sealer based on
MTA, providing a
biocompatible
and effective root
canal filling. It is
premixed and pre-
loaded in a
syringe, which
allows a complete
filling of the
entire root canal
including
accessory and
lateral canals. The
product is
eugenol-free and
will not impede | DIA-ROOT BIO
Sealer is a
hydraulic
material, and a
premixed form
that does not
require mixing. It
blocks the root
canal by
hardening by
reacting with
water in the oral
cavity. It is
contained in a
waterblocked
syringe and
corresponds to
ISO 6876:2012,
Dentistry-Root |
| | adhesion inside
the root canal. | adhesion inside
the root canal. | canal sealing
materials.
DIAROOT
BIO Sealer has
two models and
they are packaged
with components;
Disposable tip,
Silicone cap. |
| Composition | MTA powder,
Zirconium oxide,
polyethylene
glycol, propylene
glycol, fumed
silica, bentonite
clay,
hydroxypropyl
methylcellulose,
radiopacifiers | MTA powder
(Calcium silicates,
Calcium
aluminates,
Calcium
aluminoferrite,
Calcium sulfates),
Bentonite clay, n-
methyl-2
pyrrolidone,
Hypromellose
(alternate name
for hydroxypropyl
methylcellulose) | Calcium Silicate
- Calcium
Aluminate - Ytterbium
Trifluoride - Zirconium Oxide
- Silanamine,
1,1,1-
trimethyl-N-
(trimethylsilyl)-,
hydrolysis
products with
silica (fumed
silica) - Hydroxypropyl
Methylcellulose - Polyethylene
glycol 400 - Polyethylene
glycol 200 - Sorbitan
- White Mineral
Oil- |
| Form | Pre-mixed paste | | Pre-mixed paste |
| Work Time | 25-30 minutes | | > 60 minutes |
| Setting Time | Within 24 hours | | 17mm | | Not less than 17
mm |
| Film Thickness | 45 minutes |
| Setting Time | 45-60 minutes | 17mm | 29mm |
| Film Thickness | 60 minutes | |
| Setting Time | 10-15 minutes | 17mm | >17mm | |
| Film Thickness | 60 minutes | |
| Setting Time | 10-15 minutes | 70 minutes | |
| Flow | > 17mm | 29mm | |
| Film Thickness | 17mm | 29mm | |
| Film Thickness |