Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material composition and physical properties of a root canal filling material, with no mention of AI or ML.

Therapeutic

Yes
The device is a therapeutic device because its intended use includes filling root canals, repairing root perforations, and pulp capping, all of which are treatments aimed at healing or correcting conditions within the tooth structure.

Diagnostic

No

The SmartMTA Capsule is described as a root canal filling material and restorative agent, with its intended uses focused on repair and filling of dental structures, not on diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states the major compositions are physical materials (Calcium Carbonate, Silicon Dioxide, etc.) and distilled water, forming a putty that hardens. This is a physical material, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended uses listed are all related to dental procedures performed directly on a patient's teeth and surrounding tissues (root canal filling, repair of perforations, apical plug, root end filling, pulp capping, pulpotomy). These are therapeutic and restorative procedures.
Device Description: The device is a material (powder and water mixture) that is placed into the oral environment and hardens. It is a physical material used for filling and sealing.
Lack of Diagnostic Purpose: An IVD is a device used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform any such analysis of biological specimens.

The SmartMTA Capsule is a dental material used for treatment and repair, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SmartMTA Capsule is indicated for use as:

Orthograde root canal filling material
Repair of root perforations during root canal therapy (endodontic therapy), or as a consequence of internal and external resorption.
Repair of root canals as an apical plug during apexification
Root end filling
Pulp capping
Pulpotomy/Partial Pulpotomy

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

KIF

Device Description

The major compositions of the SmartMTA Capsule are Calcium Carbonate (CaCO3), Silicon Dioxide (SiO₂), Aluminum Oxide (Al₂O₃), Zirconium Oxide (ZrO₂) and Distilled water and it has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water and is used in a putty form which gradually hardens in the oral environment.

SmartMTA Capsule is ideal for orthograde root canal filling. SmartMTA Capsule is compositionally formulated to have the physical properties, setting requirements and characteristics necessary for a clinically effective root canal filling material.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Root canal, pulp chamber

Indicated Patient Age Range

Adult and Pediatric

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)

Discussion of Clinical Test Performed:
There was no clinical testing required to support the medical device as the indications for use are equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the use of the device.

The Biological Safety Evaluation report done on the predicate device (Ref BSE-2021-19) demonstrates that the composition of the cement/water is biologically safe and effective. The SmartMTA Capsule uses exactly the same cement composition with a predetermined cement / water ratio (200mg/140); therefore we are confident of the safety and effectiveness of SmartMTA Capsule.

In addition, the safe clinical use historical data from RetroMTA also demonstrates the safety and effectiveness of the cement / water composition. The following complaint data from Year 2018 to June 2022 confirms the safety: # of RetroMTA sold units vs # of complaints:

-Small "SmartMTA "(private label) / "Retro MTA" (BioMTA): 930 units (x 10 vials) = 9,300 vials: no complaint to date.

-Large "SmartMTA "(private label) / "Retro MTA" (BioMTA): 633 units (x 50 vials) = 31,650 vials: no complaint to date.

-The FDA MAUDE data base was also reviewed for RetroMTA (product code KIF) and similar MTA devices Product Code KIF,

-For 2022, 0 to date No MTA type sealant issue reported
-For 2021, 1 reportable event where the MTA did not properly set causing pain to the patient, the tooth was eventually extracted.
-For 2020, 0 reportable event
-For 2019, 0 reportable event

-For 2018, 0 reportable event

-For 2017, 0 reportable event

In addition, the verification and validation testing of the device was found to be acceptable and supports the claims of substantial equivalence.

Discussion of Non-clinical Tests Performed for determination of Substantial Equivalence:
The bench test provided substantial information and validation of the appropriate mixing ratio to meet the expectations of pediatric dentists for their specific use. Repackaging the SmartMTA product into a triturable, auto-mix capsule form will help make the mixing of the material faster, provide a predictable mix consistency no matter the experience/skill of the assistant, and will provide an alternative method by allowing the MTA material to be directly applied to the pulp chamber without contact to any other surfaces or instruments in the dental operatory compared to the predicate device "hand mix" material. This technique also reduces the risk of cross contamination, as the individually sealed, prefilled capsule reduces the amount of contact with the product prior to placement into the tooth. By the ability to apply directly from the tip of the capsule, virtually no opportunity is given to contaminate the product prior to use. These benefits were validated by the overwhelmingly positive responses from the sampled end-user dentists.

Additional testing data and correlation with ISO 6876:2012:
The difference in thickness and consistency is due to the difference in the mixing ratio of water / cement:

The preconized ratios are the following for the candidate and the predicate devices:
-RetroMTA is 1:0.3 / 1 to 0.5=powder: water,
-SmartMTA Capsule is different due to 1:0.7=powder: water.

Test	criteria	Candidate device 200/160	Candidate device 200/140	RetroMTA
Flow:	>17mm		9.375 mm	not tested
Working time:	≤30min	20 minutes	not tested	not tested
Setting time:	3hr30min ±10%	3h35 minutes	60 minutes	2 minutes 30 s to 27 minutes
Film thickness:	≤50μm	43μm	not tested	not tested
Solubility

Regulation Number and Section

§ 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.

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.

March 24, 2023

Sprig Oral Health Technologies, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K230797

Trade/Device Name: SmartMTA Capsule Regulation Number: 21 CFR 872.3820 Regulation Name: Root canal filling resin Regulatory Class: Class II Product Code: KIF Dated: March 22, 2023 Received: March 22, 2023

Dear Prithul Bom:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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 -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230797

Device Name SmartMTA Capsule

Indications for Use (Describe) The SmartMTA Capsule is indicated for use as:

Orthograde root canal filling material
Repair of root perforations during root canal therapy (endodontic therapy), or as a consequence of internal and external resorption.
Repair of root canals as an apical plug during apexification
Root end filling
Pulp capping
Pulpotomy/Partial Pulpotomy

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K230797

Section 5: 510 K Summary

Application Information: 1.

Date Prepared: February 10, 2023 Company Name: Sprig Oral Health Technologies, Inc. Address: 6140 Horseshoe Bar Road, Suite L, LOOMIS, CA 95650 Contact: Ricky Quintana Designation: Director of Operations Email: ricky@sprigusa.com Phone #: 1-916-542-4545 Fax #: N/A List of devices for which clearance is requested:

SmartMTA Capsule (common Name: root filling material)

2. Name of the Device:

Trade name: SmartMTA Capsule (common name: root filling material) Device Type: Root Canal Filling material Regulation Description: Root Canal Filling Resin Review Panel: Dental Regulation Number: 21 CFR 872.3820 Device class: Class II Product Code: KIF

3. Predicate Device Information:

The legally marketed devices to which substantial equivalence is being claimed are:

Table 5A – Predicate Devices

Device Manufacturer 510K number

4

Device	Manufacturer	510 K #
RetroMTA -
OrthoMTA II	BioMTA	K132825

4. Device Description:

The major compositions of the SmartMTA Capsule are Calcium Carbonate (CaCO3), Silicon Dioxide (SiO₂), Aluminum Oxide (Al₂O₃), Zirconium Oxide (ZrO₂) and Distilled water and it has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water and is used in a putty form which gradually hardens in the oral environment.

SmartMTA Capsule is ideal for orthograde root canal filling. SmartMTA Capsule is compositionally formulated to have the physical properties, setting requirements and characteristics necessary for a clinically effective root canal filling material.

5. Device Configuration:

| SmartMTA Capsule | Capsule: 20 ea.

Portland cement powder: 4g (0.2g cap
x 20 ea.),
Solution: 2.8cc (0.14cc x 20 ea.)
-IFU |
|------------------|------------------------------------------------------------------------------------------------------------------------|
| SmartMTA Capsule | Capsule: 10ea
Portland cement Powder: 2g (0.2g cap
x 10 ea.),
Solution: 1.4cc (0.14cc x 10 ea.)
-IFU |

Device Composition: 6.

Trade Name	Materials	Weight (%)
Portland Cement
(powder form)	Calcium Carbonate (CaCO3)	61.0
	Silicon Dioxide (SiO2)	11.7
	Aluminum Oxide (Al2O3)	2.3
	Zirconium Oxide (ZrO2)	25
Total	-	100
Distilled Water	Distilled water	0.14cc

5

7. Indications for Use:

SmartMTA Capsule root repair materials is indicated for use as

An orthograde root canal filling material
Repair of root perforations during root canal therapy (endodontic therapy), or as a consequence of internal and external resorption.
Repair of root canals as an apical plug during apexification
Root end filling
Pulp capping
Pulpotomy/Partial Pulpotomy

8. Substantial Equivalence:

SmartMTA Capsule has exactly the same physical and biocompatible properties and demonstrates comparable performance specifications to RetroMTA-OrthoMTA II Material. In addition, SmartMTA Capsule has a comparable delivery system to RetroMTA-OrthoMTA II Material. The bench and biocompatibility testing performed on the candidate and predicate device demonstrate that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. Therefore, it is concluded that SmartMTA Capsule is safe, effective, and is substantially equivalent to the predicate device.

| Item | Candidate Device | Predicate Device | Equivalence
comparisons |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | SmartMTA Capsule | RetroMTA-OrthoMTA II | - |
| Manufacturer | BioMTA | BioMTA | Same as
predicate |
| 510(K) Number | - | K132825 | - |
| Device
Classification
Name | Root filling material | Root filling Material | Same
classification
as predicate |
| Regulation
Number | 872.3820 | 872.3820 | Same
Regulation #
as predicate |
| Product Code | KIF | KIF | Same
Product code
as predicate |
| Regulatory
Class | Class II | Class II | Same class II
as predicate |
| Patient
population | Adult and Pediatric | Adult and Pediatric | Same as
predicate |
| Device
description | The major compositions of
the SmartMTA Capsule are
Calcium Carbonate
(CaCO3), Silicon Dioxide
(SiO2), Aluminum Oxide
(Al2O3), Zirconium Oxide
(ZrO2) and Distilled water,
and it has been showing
good sealing ability and
biocompatibility. It is
prepared as a mixture of
powder and water and is
used in a putty form which
gradually hardens in the
oral environment.
SmartMTA Capsule is ideal
for orthograde root canal
filling. SmartMTA Capsule
is compositionally
formulated to have the
physical properties, setting
requirements and
characteristics necessary
for a clinically effective
root canal filling material. | The major compositions of the
RetroMTA-OrthoMTA II are Calcium
Carbonate (CaCO3), Silicon Dioxide
(SiO2), Aluminum Oxide (Al2O3),
Zirconium Oxide (ZrO₂) and
Distilled water, and it has been
showing good sealing ability and
biocompatibility. It is prepared as a
mixture of powder and water and
is used in a putty form which
gradually hardens in the oral
environment. RetroMTA-
OrthoMTA II is ideal for orthograde
root canal filling. It is
compositionally formulated to have
the physical properties, setting
requirements and characteristics
necessary for a clinically effective
root canal filling material. | Same as
formula as
the
predicate,
except our
device does
not require
hand mixing. |
| Device Photo
and content | Image: SmartMTA Capsule boxes and foil packet | Image: RetroMTA box and detailed content:
Image: detailed content | Predicate:
Powder form
contained in
a aluminum
fail packet,

SmartMTA
Capsule:
Powder form
contained in
chamber 2
inside the
capsule and
distilled |
| |
detailed content:

Inner Body
Tip
Outer body
Red Plunger
Punch bottom at the
time of use to
puncture the foil
barrier allowing the
mixing of cement
and water just before
use. | 1) Mixing tray
Distilled water
Portland cement powder in
plastic vial within
aluminum foil packet | water in chamber 1 |
| Outer container
material
(primary
packaging) | Capsule:
Inner Body: (CAS # 9002-88-4 (Low density Polyethylene))
Tip: CAS # 9010-79-1(1-propene, polymer with ethene)
Outer body: (Marlex 9708 HDPE)
Red Plunger: (CAPILENE T 50) | Aluminum foil, Plastic vials | Primary
Packaging is
a bit
different
from the
predicate,
however the
primary
packaging
material used
for the
candidate
device are
safe (see
SDS
attached in
this
submission) |
| Indications for
Use | • Orthograde root canal filling material
• Repair of root perforations during root canal therapy (endodontic therapy), or as a consequence of internal and external resorption.
• Repair of root canals as an apical plug during | • Orthograde root canal filling material
• Repair of root perforations during root canal therapy (endodontic therapy), or as a consequence of internal and external resorption.
• Repair of root canals as an apical plug during apexification | Same as
predicate
(Predicate
device: hand
mix)
(Our device:
auto Mix) |

6

7

8

	apexification
	• Root end filling	• Root end filling
	• Pulp capping	• Pulp capping
	• Pulpotomy/Partial
Pulpotomy
Similar Physical
Properties	Same material used, only
different ratio Powder /
water
200/140 or 1 to 0.7
Capsule auto mix
(Consistent mix)	Same material used, only different
ratio Powder / water varying from:
-1 to 0.3
-1 to 0.5
Upon hand mixing (variable mix
consistency).	Same as
predicate
See
comments on
Device
differences
section
below this
comparison
table
Biocompatibility	Biocompatible
(The fact that the powder
cement and water are
contained in the capsule
does not alter
biocompatibility testing.
The raw materials for
primary packaging are safe)	Biocompatible	Same as
predicate
(same raw
material and
formula)
only
different
packaging
SDS of
packaging
material
(including
capsule)
Sterilization	Non-sterile	Non-sterile	Same as
predicate
Chemical
Components	Materials Weight
(%) Portland
Cement 75 ZrO2 25 Distilled
water 0.14cc Powder/water ratio: 1 to 0.7				Materials Weight (%) Portland
Cement 75 ZrO2 25 Distilled
water Tube of
0.15g Powder/water ratio: 1 to 0.3, 1 to
0.5				Same as
predicate
(same
ingredients)
Different
Powder /
water ratio

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------------	---------	---------	-----------------------------------

9. Similarities and differences:

Summary of Technical Characteristics:

The clinical, technical, and biological characteristics of our device and the predicate device are exactly the same. Same recipe of the predicate device, same manufacturer. Only the way the cement and water are packaged and the mixing at the time of use are different.

Device differences:

The only 2 differences between our device and the predicate are the Capsule (primary packaging (predetermined amount of powder and predetermined amount of water contained in the capsule)) instead of using a tray to mix an amount of powder (contained in an aluminum foil packet) with estimated amount of water hand mix (contained in 2 small bottles/vials) to consistency for use).

And the difference in Powder / water ratio (1 to 0.7 for our device, 1 to 0.3 / 1 to 0.5 for predicate).

This difference in fact assures a consistent powder/water ratio each time, compared to an inconsistent hand mix powder water on a tray prior to use (like the predicate).

The same formula is used and due to its hydrophilic nature, the difference of powder/ water ratio does not bring an additional risk or level of concerns for the safe and effective use of our device.

Additionally, the primary packaging (SmartMTA Capsule) materials used are known plastics (frequently used in the food and medical device industries) which do not alter the powder / water content in the capsule (see Cytotoxicity test done on FFF of our device SmartMTA Capsule).

For detailed assessment of the candidate and predicate device differences see Section 12 "Substantial Equivalence Discussion" of this 510K submission.

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10. Discussion of Clinical Test Performed:

There was no clinical testing required to support the medical device as the indications for use are equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the use of the device.

The Biological Safety Evaluation report done on the predicate device (Ref BSE-2021-19) demonstrates that the composition of the cement/water is biologically safe and effective. The SmartMTA Capsule uses exactly the same cement composition with a predetermined cement / water ratio (200mg/140); therefore we are confident of the safety and effectiveness of SmartMTA Capsule.

In addition, the safe clinical use historical data from RetroMTA also demonstrates the safety and effectiveness of the cement / water composition. The following complaint data from Year 2018 to June 2022 confirms the safety: # of RetroMTA sold units vs # of complaints:

-Small "SmartMTA "(private label) / "Retro MTA" (BioMTA): 930 units (x 10 vials) = 9,300 vials: no complaint to date.

-Large "SmartMTA "(private label) / "Retro MTA" (BioMTA): 633 units (x 50 vials) = 31,650 vials: no complaint to date.

-The FDA MAUDE data base was also reviewed for RetroMTA (product code KIF) and similar MTA devices Product Code KIF,

-For 2022, 0 to date No MTA type sealant issue reported
-For 2021, 1 reportable event where the MTA did not properly set causing pain to the patient, the tooth was eventually extracted.
-For 2020, 0 reportable event
-For 2019, 0 reportable event

-For 2018, 0 reportable event

-For 2017, 0 reportable event

In addition, the verification and validation testing of the device was found to be acceptable and supports the claims of substantial equivalence.

11. Discussion of Non-clinical Tests Performed for determination of Substantial Equivalence:

The bench test provided substantial information and validation of the appropriate mixing ratio to meet the expectations of pediatric dentists for their specific use. Repackaging the SmartMTA product into a triturable, auto-mix capsule form will help make the mixing of the material faster, provide a predictable mix consistency no matter the experience/skill of the assistant, and will provide an alternative method by allowing the MTA material to be directly applied to the pulp chamber without contact to any other surfaces or instruments in the dental operatory compared to the predicate device "hand mix" material. This technique also reduces the risk of cross contamination, as the

11

individually sealed, prefilled capsule reduces the amount of contact with the product prior to placement into the tooth. By the ability to apply directly from the tip of the capsule, virtually no opportunity is given to contaminate the product prior to use. These benefits were validated by the overwhelmingly positive responses from the sampled end-user dentists.

Additional testing data and correlation with ISO 6876:2012:

ISO 6876:2012 is a specific standard, that by definition, relates to root canal sealing materials. And while this is true of the use of root canal sealers, of which MTA can be used, the candidate is specifically designed for use in the pulp chamber of the tooth and not in the actual tooth's root canal system as specified in the standard. A root canal of a tooth is a long and narrow passage that leads from the pulp chamber to the apex of the tooth and exits out the end, or tips of the roots. In a three rooted tooth you would expect to have one pulp chamber and three canals, likewise in a two rooted tooth you would expect to have one pulp chamber and two root canals, although this is not always a set rule. It is therefore very important to have a specific consistency and thickness of material when used in this small, confined space. The candidate is to be used in the pulp chamber of the tooth only and is not intended to be used down inside the root canal system. This makes the specifications for thickness and working time less important, as the dentist is much more interested in the ability to "pack" the material or to condense it into the pulp chamber. In essence, the candidate is used to cover over the root canal system and seal it from the outside. As noted in the standards introduction, Section 1 (scope) the standard only includes orthograde use, not retrograde. Our intended use is similar to a retrograde application because it is not intended to be used within the root canal system of the tooth. Because of this difference, the dentist prefers the material to be as thick as possible to mold/condense/shape the material in the preparation. He/she would then place a base material over the candidate and continue to restore the tooth with restorative composite or a stainless steel or zirconia crown. The intent of the candidate is to seal the outside of the root canal system to prevent bacteria from entering the internal root canal system of the tooth. The candidate is designed to be able to set in the presence of moisture. As with concrete (a very similar material), the ability for the candidate to set slower actually makes for a stronger finished product. This would not be the case with a sealer that was intended to be used within the root canal system of the tooth. We are talking about two very different applications, and in the authors professional opinion, the ISO 6876 standard is specifically designed for a material that will be used within the root canal system of a tooth, a location and use for which the candidate is not intended.

ISO 6876:2012 data testing:

The difference in thickness and consistency is due to the difference in the mixing ratio of water / cement:

The preconized ratios are the following for the candidate and the predicate devices: -RetroMTA is 1:0.3 / 1 to 0.5=powder: water,

-SmartMTA Capsule is different due to 1:0.7=powder: water.

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| Test | criteria | Candidate device
200/160 | Candidate
device
200/140 | RetroMTA |
|---------------------------|------------------|-----------------------------|--------------------------------|------------------------------------|
| Flow: | >17mm | | 9.375 mm | not tested |
| Working
time: | ≤30min | 20 minutes | not tested | not tested |
| Setting time: | 3hr30min
±10% | 3h35 minutes | 60 minutes | 2 minutes
30 s to 27
minutes |
| Film
thickness: | ≤50μm | 43μm | not tested | not tested |
| Solubility |