(2 days)
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
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.
Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on what is stated and explicitly noting what is not mentioned.
Device Name: SmartMTA Capsule
Predicate Device: RetroMTA-OrthoMTA II (K132825)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" for the device in the typical sense of a target performance threshold that must be met. Instead, it compares the SmartMTA Capsule's performance to the predicate device and relevant ISO standards, explaining deviations. The key performance metrics and their reported values are derived from the ISO 6876:2012 standard testing where applicable.
| Test / Performance Metric | Acceptance Criteria (from ISO 6876:2012) | Candidate Device (SmartMTA Capsule) Performance (200/140 ratio) | Candidate Device (SmartMTA Capsule) Performance (200/160 ratio) | Predicate Device (RetroMTA) Performance | Notes on Acceptance / Deviations |
|---|---|---|---|---|---|
| Flow | > 17mm | 9.375 mm | Not explicitly stated if it met > 17mm, but implied to be in the "established range" | Not tested | Candidate device (200/140 ratio) did not meet criteria, but explained as not critical due to intended use and hydrophilic nature. 200/160 ratio did fall in range. |
| Working Time | ≤ 30 min | Not tested | 20 minutes | Not tested | Candidate device (200/140 ratio) not tested/measurable according to standard. 200/160 appeared to meet the criteria. Explained as not critical due to intended use and hydrophilic nature, and dependency on water-to-cement ratio. |
| Setting Time | 3.5 hours ± 10% (3h30min ± 10%) | 60 minutes | 3h35 minutes | 2.5 minutes to 27 minutes | Candidate device (200/140 ratio) setting time of 60 minutes is significantly faster than 3.5 hours ± 10%. Candidate device (200/160 ratio) setting time of 3h35 minutes meets the criteria. Predicate showed a wide range, some much faster than the standard. |
| Film Thickness | ≤ 50μm | Not tested | 43μm | Not tested | Candidate device (200/140 ratio) not tested/measurable according to standard. 200/160 ratio met the criteria. Explained as not critical due to intended use. |
| Solubility | < 3% | < 3% | 1.92% | 1.4% | Both candidate device ratios met the criteria. Predicate also met the criteria. |
| Radiopacity | ≥ 3.0mm | 4.33 mm | 4.4 mm | 5.0 mm | Both candidate device ratios met the criteria. Predicate also met the criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for each specific test (Flow, Working Time, etc.). The mention of "candidate device 200/160" and "candidate device 200/140" implies at least two different mix ratios were tested for the SmartMTA Capsule, and for some tests, multiple measurements were taken (e.g., 4.33mm and 4.4mm for Radiopacity). However, the number of samples per test is not provided.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. The testing seems to be bench (non-clinical) testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Experts for Ground Truth: Not applicable for the non-clinical, bench testing described. The "ground truth" (or target performance) was established by the ISO 6876:2012 standard.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable for the non-clinical, bench testing described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. The document states: "There was no clinical testing required to support the medical device as the indications for use are equivalent to the predicate device."
- Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as no MRMC study or AI component is mentioned.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: No, a standalone performance study in the context of an algorithm or AI is not applicable. The device is a physical root canal filling material. The non-clinical tests assess the material's properties directly.
7. Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical tests, the "ground truth" was the ISO 6876:2012 standard for root canal sealing materials. The document also refers to the predicate device's performance as a comparison point.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable.
Summary of the Study:
The provided document describes a non-clinical bench testing study comparing the SmartMTA Capsule to its predicate device (RetroMTA-OrthoMTA II) and to the specifications of the ISO 6876:2012 standard for root canal sealing materials.
The study aimed to demonstrate substantial equivalence to the predicate device, primarily focusing on physical and chemical properties derived from the same source materials. The key difference highlighted is the SmartMTA Capsule's pre-packaged, automatic mixing system (capsule form) compared to the predicate's manual hand-mixing, which leads to a consistent powder-to-water ratio.
The study found that while some properties (Flow, Working Time, Film Thickness for the 200/140 ratio) did not strictly meet all ISO 6876:2012 criteria, these deviations were explained as non-critical due to the device's specific intended use (in the pulp chamber, not deep within the narrow root canal system) and its hydrophilic nature. The faster setting time for the 200/140 ratio was noted. Other critical properties like Solubility and Radiopacity met the ISO standard.
The manufacturer argues that the consistent mixing provided by the capsule form offers advantages in predictability and ease of use, and that historical clinical data from the predicate device (which shares the same core formulation) supports the safety and effectiveness. Biocompatibility testing on the candidate device (cytotoxicity) was also performed and confirmed safety. No new clinical studies were conducted for this 510(k) submission.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
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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
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| 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 capx 20 ea.),- Solution: 2.8cc (0.14cc x 20 ea.)-IFU |
|---|---|
| SmartMTA Capsule | Capsule: 10ea- Portland cement Powder: 2g (0.2g capx 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 |
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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 | Equivalencecomparisons |
|---|---|---|---|
| Device Name | SmartMTA Capsule | RetroMTA-OrthoMTA II | - |
| Manufacturer | BioMTA | BioMTA | Same aspredicate |
| 510(K) Number | - | K132825 | - |
| DeviceClassificationName | Root filling material | Root filling Material | Sameclassificationas predicate |
| RegulationNumber | 872.3820 | 872.3820 | SameRegulation #as predicate |
| Product Code | KIF | KIF | SameProduct codeas predicate |
| RegulatoryClass | Class II | Class II | Same class IIas predicate |
| Patientpopulation | Adult and Pediatric | Adult and Pediatric | Same aspredicate |
| Devicedescription | The major compositions ofthe SmartMTA Capsule areCalcium Carbonate(CaCO3), Silicon Dioxide(SiO2), Aluminum Oxide(Al2O3), Zirconium Oxide(ZrO2) and Distilled water,and it has been showinggood sealing ability andbiocompatibility. It isprepared as a mixture ofpowder and water and isused in a putty form whichgradually hardens in theoral environment.SmartMTA Capsule is idealfor orthograde root canalfilling. SmartMTA Capsuleis compositionallyformulated to have thephysical properties, settingrequirements andcharacteristics necessaryfor a clinically effectiveroot canal filling material. | The major compositions of theRetroMTA-OrthoMTA II are CalciumCarbonate (CaCO3), Silicon Dioxide(SiO2), Aluminum Oxide (Al2O3),Zirconium Oxide (ZrO₂) andDistilled water, and it has beenshowing good sealing ability andbiocompatibility. It is prepared as amixture of powder and water andis used in a putty form whichgradually hardens in the oralenvironment. RetroMTA-OrthoMTA II is ideal for orthograderoot canal filling. It iscompositionally formulated to havethe physical properties, settingrequirements and characteristicsnecessary for a clinically effectiveroot canal filling material. | Same asformula asthepredicate,except ourdevice doesnot requirehand mixing. |
| Device Photoand content | Image: SmartMTA Capsule boxes and foil packet | Image: RetroMTA box and detailed content:Image: detailed content | Predicate:Powder formcontained ina aluminumfail packet,SmartMTACapsule:Powder formcontained inchamber 2inside thecapsule anddistilled |
| detailed content:1) Inner Body2) Tip3) Outer body4) Red PlungerPunch bottom at thetime of use topuncture the foilbarrier allowing themixing of cementand water just beforeuse. | 1) Mixing tray2) Distilled water3) Portland cement powder inplastic vial withinaluminum foil packet | water in chamber 1 | |
| Outer containermaterial(primarypackaging) | Capsule:1) Inner Body: (CAS # 9002-88-4 (Low density Polyethylene))2) Tip: CAS # 9010-79-1(1-propene, polymer with ethene)3) Outer body: (Marlex 9708 HDPE)4) Red Plunger: (CAPILENE T 50) | Aluminum foil, Plastic vials | PrimaryPackaging isa bitdifferentfrom thepredicate,however theprimarypackagingmaterial usedfor thecandidatedevice aresafe (seeSDSattached inthissubmission) |
| Indications forUse | • 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 aspredicate(Predicatedevice: handmix)(Our device:auto Mix) |
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| apexification | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| • Root end filling | • Root end filling | ||||||||||||||||||||||
| • Pulp capping | • Pulp capping | ||||||||||||||||||||||
| • Pulpotomy/PartialPulpotomy | |||||||||||||||||||||||
| Similar PhysicalProperties | Same material used, onlydifferent ratio Powder /water200/140 or 1 to 0.7Capsule auto mix(Consistent mix) | Same material used, only differentratio Powder / water varying from:-1 to 0.3-1 to 0.5Upon hand mixing (variable mixconsistency). | Same aspredicateSeecomments onDevicedifferencessectionbelow thiscomparisontable | ||||||||||||||||||||
| Biocompatibility | Biocompatible(The fact that the powdercement and water arecontained in the capsuledoes not alterbiocompatibility testing.The raw materials forprimary packaging are safe) | Biocompatible | Same aspredicate(same rawmaterial andformula)onlydifferentpackagingSDS ofpackagingmaterial(includingcapsule) | ||||||||||||||||||||
| Sterilization | Non-sterile | Non-sterile | Same aspredicate | ||||||||||||||||||||
| ChemicalComponents | Materials Weight(%) PortlandCement 75 ZrO2 25 Distilledwater 0.14cc Powder/water ratio: 1 to 0.7 | Materials Weight (%) PortlandCement 75 ZrO2 25 Distilledwater Tube of0.15g Powder/water ratio: 1 to 0.3, 1 to0.5 | Same aspredicate(sameingredients)DifferentPowder /water ratio |
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| Shelf life | 2 years | 3 years | Similar topredicatedevice |
|---|---|---|---|
| ------------ | --------- | --------- | ----------------------------------- |
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
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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 device200/160 | Candidatedevice200/140 | RetroMTA |
|---|---|---|---|---|
| Flow: | >17mm | 9.375 mm | not tested | |
| Workingtime: | ≤30min | 20 minutes | not tested | not tested |
| Setting time: | 3hr30min±10% | 3h35 minutes | 60 minutes | 2 minutes30 s to 27minutes |
| Filmthickness: | ≤50μm | 43μm | not tested | not tested |
| Solubility | < 3% | 1.92% | < 3% | 1.4% |
| Radiopacityfulfilled: | ≥3.0mm | 4.4 mm | 4.33 mm | 5.0 mm |
The following test data was gathered according to the ISO 6876:2012 testing for the candidate and predicate devices: see summary table below:
As defined in the testing data from the Candidate and predicate device the ISO 6876:2012 was used and followed for most parts.
However, some of the testing recommended by the standard were either not executed / undertaken / measurable according to the standard or fell outside the acceptable / recognize test results range such as the Flow, working time, film thickness for the 200/140 ratio of subject device and predicate device.
The flow, working time and film thickness are not critical for the safety and effectiveness of this sealing material due to the fact that it is a hydrophilic material going into the patient cavity (humid environment (body fluid such as blood, saliva..., which will maintain a humid environment until full setting of material which could take up to 24 hours, and doing so assuring a stronger bound).
Those set of variables flow, working time and film thickness are dependent of and in correlation with the amount / ratio of powder and distilled water added prior to use and the dentist preparing the mixing (adding more or less water to the powder according to the dentist's preferred consistency and human factor not reproducing the exactly the same mixing ratio each time, therefore entering an additional variable and in fact a variable range of powder / water ratio.
The human factor, dentist assistant or dentist himself, is not able to repeatedly assure the same mixing powder water ratio. This does not affect the intended use of the root canal sealing material as discussed above due to its hydrophilic nature. This is also confirmed by the safe and historical clinical use of the predicate device already on the market.
The working time (allowing the material to be handled without hardening too much) depends on the amount of water mixed with the powder, therefore a waterier mixing will allow a bit more time to work with. For the predicate device these tests were not measurable with the manufacturer IFU's since it falls outside the established range from the standard ISO 6876 for overall root canal filling materials.
For the candidate device (SmartMTA Capsule) the flow test results showed to be outside
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the established standard range for the test done on the 200/140 ratio but do fall in the established range for the 200/160 ratio on first battery of test. For the same reason defined above for the predicate device, this does not constitute a concern according to the intended use of the device.
For the same reason the Working time and Film thickness were not conducted either since they are not measurable according to the standard set ranges.
However, the fact that flow, working time and film thickness were not tested and or not measurable according to the ISO 6876:2012 for the 200/140 ratio does not raise additional risk, the predicate device has been used on the market for several years with the same formula and distilled water (variable ratio according to amount of powder and water mixed by dentist upon use)
In addition, Biocompatibility testing (cytotoxicity) has been performed on the candidate device (see Biocompatibility section 15 of this submission, and biocompatibility data from predicate and candidate device confirming it is safe for use).
Although the difference in the ratio of water to be mixed, and of the primary packaging, there is no difference in biocompatibility.
A biological evaluation was also conducted on the predicate device and confirms the safe clinical use of this formulation.
Shelf life: Tested for the ratio 200/140 and for ratio 200/160 and determined to be 2 years.
This difference in fact assures a consistent powder/water ratio each time with the correct consistency for the device's intended use. Therefore, as discussed above, those differences do not bring an additional risk or level of concern for the safe and effective use of our device. The device still has the same characteristics in terms of material (Exact same formulation) and indications for use of the cleared predicate device.
In addition, this bench top test allowed us to find the ratio that would be thick enough to support the needs of the dentist while still making sure that the capsule would function as designed and not clog or malfunction in dispensing the material properly.
The ability to provide the market with an individually packaged, triturable auto-mix MTA capsule will not only make the process of using MTA in the pediatric dental office easier, faster, and produce a more predictable mixture no matter what assistant the dentist is using that particular day but will also reduce the risk of cross contamination. These benefits, validated by the participating dentist, stand to make this new product a valuable tool for pediatric dentists striving to provide the best care possible for their little patients.
12. Conclusions:
The Sprig Oral Health Technologies, Inc. SmartMTA Capsule is substantially equivalent in terms of performance, indications for use, and biocompatibility to the cleared and marketed predicate devices RetroMTA-OrthoMTA II (K132825). Any technological
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differences between the SmartMTA Capsule and the predicate device do not raise any questions regarding the safety and effectiveness of the subject device (as defined in detailed in section 12 "Substantial Equivalence Discussion" of this 510K submission).
The information provided in this submission supports the substantial equivalence to the predicate device and that the system is safe and effective for the users/operators.
The conclusions drawn from the nonclinical and clinical tests demonstrate that the SmartMTA Capsule is as safe, as effective, and performs as well as or better than the legally marketed device identified.
§ 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.