(283 days)
-
Sealing the root canal of permanent teeth;
-
Internal reabsorption treatment;
BIO-C SEALER ION* is a ready-to-use injectable bioceramic root canal sealer, developed for sealing the root canals and for the treatment of internal reabsorption. The product is a single paste provided in a syringe with disposable intracanal tips to be applied directly into the root canal system. BIO-C SEALER ION* is an insoluble and alkaline material, which requires the presence of water to set and harden. The product presents suitable radiopacity, demonstrating adequate physical properties inherent to root canal sealer materials.
The document describes the non-clinical performance testing for the BIO-C SEALER ION+ device. Here is the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a direct table of acceptance criteria versus reported performance for each specific test. Instead, it states that tests were performed "according to ISO 6876:2012 Dental root canal sealing materials" and that "additional tests are also performed and incorporated into the product acceptance criteria." For biocompatibility, it states the device "has met the requirements." Based on the comparison table and the text, we can infer some details.
| Acceptance Criteria (Implied / Stated) | Reported Device Performance (BIO-C Sealed ION+) |
|---|---|
| Physical/Chemical Properties (ISO 6876:2012) | |
| Setting time (range) | 120-240 minutes (Equivalent to predicate K172701) |
| Solubility | Tested according to ISO 6876:2012 (Insoluble, similar to predicates) |
| Flow | Tested according to ISO 6876:2012 (Comparable to predicate K172701) |
| Film thickness | Tested according to ISO 6876:2012 (Comparable to predicate K172701) |
| Radiopacity | $\ge 7$ mm Al (Equivalent to predicate K172701) |
| Additional Tests (Incorporated into acceptance criteria) | |
| X-ray diffraction analysis | Performed |
| Particle size analysis | Performed |
| Viscosity and thixotropy tests | Performed |
| Color determination analysis | Performed |
| Biocompatibility (ISO 10993-1:2009) | |
| Non-mutagenic | Met requirements (demonstrated to be non-mutagenic) |
| Non-irritant to oral mucosa of hamsters | Met requirements (demonstrated to be non-irritant) |
| Non-sensitizing | Met requirements (demonstrated no sensitizing effects) |
| Absence of acute systemic toxicity after single oral administration | Met requirements (demonstrated absence of acute systemic toxicity) |
| pH | 10.5 (Equivalent to predicate K172701, for which pH is 12.5; within acceptable range for bioceramic sealers, inferred as acceptable although a specific range isn't stated). The document states "Equivalent to BIO-C SEALER" for pH, even though the values are different. This implies the difference is considered acceptable. |
| Insoluble | Stated in Principle of Operation, implying it meets the expectation for root canal sealers. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "NON-CLINICAL PERFORMANCE TESTING: BIO-C SEALER ION* has undergone extensive bench testing." It lists various tests. However, the exact sample size for each specific test (e.g., how many units were tested for setting time, or how many animals for each biocompatibility test) is not specified in the provided text.
The data provenance is non-clinical/bench testing and animal testing for biocompatibility. No human data is mentioned. The manufacturer is Angelus Indústria de Produtos Odontológicos S/A, based in Brazil. Therefore, the data provenance for non-clinical testing would be from their labs or contracted facilities. The study is prospective in the sense that the device was specifically tested to meet the standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable to the provided text. The performance assessment relied on established international standards (ISO 6876:2012 for physical/chemical properties and ISO 10993-1:2009 for biocompatibility). These standards define test methodologies and criteria, rather than requiring expert consensus on a test set's ground truth in the way a diagnostic AI tool would. The experts involved would be those performing and interpreting the ISO standard tests, but their specific number or qualifications are not detailed.
4. Adjudication Method for the Test Set:
This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies, particularly for diagnostic devices where multiple human readers assess cases. This document describes non-clinical performance and biocompatibility testing against international standards, not a clinical trial requiring human adjudication of results.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
A Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The device is a root canal filling material, and the evaluation is non-clinical, focusing on its physical, chemical, and biological properties, not its impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This section is not applicable. The device is a physical dental material, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept here.
7. The Type of Ground Truth Used:
The "ground truth" for the device's performance is established by conformance to international standards (ISO 6876:2012 for dental root canal sealing materials and ISO 10993-1:2009 for biological evaluation of medical devices). For biocompatibility, this means the device did not elicit mutagenic, irritant, sensitizing, or acute systemic toxic effects as defined by the standard's methodologies. For physical properties, it means the device's setting time, solubility, flow, film thickness, and radiopacity fell within the acceptable parameters or demonstrated comparability to predicates as assessed by the standard's tests.
8. The Sample Size for the Training Set:
This section is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable as there is no training set for a physical medical device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
December 12, 2019
Angelus Industria de Produtos Odontologicos S/A Juliana Trostdorf International Regulatory Affairs Specialist Rua Waldir Landgraf, 101 Londrina, 86.031-218 Br
Re: K190537
Trade/Device Name: BIO-C Sealer Ion+ Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: September 13, 2019 Received: September 13, 2019
Dear Juliana Trostdorf:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K190537
Device Name BIO-C SEALER ION+
Indications for Use (Describe)
-
Sealing the root canal of permanent teeth;
-
Internal reabsorption treatment;
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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510(K) Summary
Angelus Indústria de Produtos Odontológicos S/A
BIO-C SEALER ION*
K190537
ADMINISTRATIVE INFORMATION
| Date prepared: | September 13th, 2019 |
|---|---|
| Manufacturer Name: | Angelus Indústria de Produtos Odontológicos S/ARua Waldir Landgraf, 101Londrina, PR 86031-218 BrazilTelephone: +55 (43) 2101-3200Fax: +55 (43) 2101-3201 |
| Official Contact: | Juliana Norder TrostdorfInternational Regulatory Affairs Specialist |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | BIO-C SEALER ION+ |
|---|---|
| Common Name: | Root Canal Filling Resin |
| Classification Regulation: | 21 CFR 872-3820, Class II |
| Product Code: | KIF |
| Classification Panel: | Dental Products Panel |
| Primary Predicate Device: | K172701 BIO-C SEALER (Angelus Indústria deProdutos Odontológicos S/A) |
| Reference Device: | K170175 ENDOSEAL MTA (MARUCHI) |
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DEVICE DESCRIPTION
BIO-C SEALER ION* is a ready-to-use injectable bioceramic root canal sealer, developed for sealing the root canals and for the treatment of internal reabsorption.
The product is a single paste provided in a syringe with disposable intracanal tips to be applied directly into the root canal system. BIO-C SEALER ION* is an insoluble and alkaline material, which requires the presence of water to set and harden. The product presents suitable radiopacity, demonstrating adequate physical properties inherent to root canal sealer materials.
PRODUCT PRESENTATION
| Reference | Product Description | Package Contents |
|---|---|---|
| 3843 | BIO-C SEALERION+ | • 4 preloaded syringes with 0.5g each• 20 disposable intracanal tips |
| 3845 | BIO-C SEALERION+ | • 1 preloaded syringe with 2g each• 5 disposable intracanal tips |
INTENDED USE
Sealing the root canals.
INDICATIONS FOR USE
-
- Sealing the root canal of permanent teeth;
-
- Internal reabsorption treatment.
COMPARISON OF TECHNOLOGY
BIO-C SEALER ION+ and BIO-C SEALER are indicated for equivalent dental applications, have comparable chemical/physical properties and performance specifications and equivalent delivery systems (syringe and disposable intracanal tips). The reference device, ENDOSEAL MTA, contains a chemical component that is found in BIO-C SEALER ION+.
The similarities and differences of BIO-C SEALER ION+ and the predicates are discussed below:
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-
BIO-C SEALER ION+, BIO-C SEALER and ENDOSEAL MTA are mainly composed of calcium silicates. BIO-C SEALER ION+ is composed of calcium and magnesium silicate, and BIO-C SEALER and ENDOSEAL MTA are composed of calcium silicates. Despite the difference between the silicates in the formulations, biocompatibility tests were conducted with the subject device and the results demonstrated that the device is biocompatible.
- v BIO-C SEALER ION+ and ENDOSEAL MTA uses calcium sulfate as setting agent, whereas BIO-C SEALER sets in the presence of moisture due to the hydration of the calcium silicates.
- v As BIO-C SEALER ION* and BIO-C SEALER are pre-mixed ready-to-use pastes, a biocompatible hydrophilic polymer is used in order to give an adequate viscosity and flow to the products. In this case, this polymer is included as a chemical component and is present in several cleared dental devices.
- ✔ Zirconium oxide is present all compositions. This component is responsible for the radiopacity of the products.
- V BIO-C SEALER ION+ and BIO-C SEALER use fumed silica (silicon oxide) as rheometry agent. This component is inert and the percentage of fumed silica used in both devices is highly similar.
-
All materials share the same Delivery System (syringe and disposable intracanal tips).
- V BIO-C SEALER ION+ and BIO-C SEALER are both provided non-sterile and have comparable setting time, solubility, flow, film thickness and radiopacity.
All materials are available as pre-mixed ready-to-use radiopaque pastes essentially designated for the equivalent dental applications and have comparable physical properties, performance specifications and share specific chemical components as can be seen above.
The table below summarizes the main similarities of BIO-C SEALER ION* and the predicate devices:
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| Element | Proposed Device(K190537) | Predicate Device(K172701) | Reference Device(K170175) | Discuss / Justify theDifferences |
|---|---|---|---|---|
| Trade Name | BIO-C SEALER ION+ | BIO-C SEALER | ENDOSEAL MTA | |
| Manufacturer | ANGELUSINDÚSTRIADEPRODUTOS ODONTOLÓGICOS S/A | ANGELUSINDÚSTRIADEPRODUTOS ODONTOLÓGICOS S/A | MARUCHI | |
| Device Description | BIO-C SEALER ION+ is a ready-to-use injectable endodonticbioceramic Sealer, suitable forobturation of root canals. | BIO-C SEALER is a ready-to-useinjectable endodontic bioceramicSealer, suitable for obturation of rootcanals. | ENDOSEAL MTA is an endodonticsealer based on MTA, providing aroot canal filling. It is premixed andpre-loaded in a syringe, which allowsa complete filling of the entire rootcanal including accessory and lateralcanals. | All three materials are ready-to-usepastes intended for permanentobturation of the root canal. Despitethe difference between the silicatesin the formulations, biocompatibilitytests were conducted with thesubject device and the resultsdemonstrated that the device isbiocompatible. |
| Composition | Calcium and magnesium silicateZirconium oxideSilicon oxidePotassium sulfateCalcium sulfateDispersing agent | Calcium silicatesCalcium oxideSilicon oxideZirconium oxideIron oxideDispersing agent | Calcium silicatesCalcium aluminatesCalcium aluminoferriteZirconium oxideCalcium sulfatesThickening agent | BIO-C SEALER ION+, BIO-C SEALERand ENDOSEAL MTA are mainlycomposed of calcium silicates. BIO-CSEALER ION+ is composed of calciumand magnesium silicate and BIO-CSEALER and ENDOSEAL MTA arecomposed of calcium silicates. Theyall share the same radiopacifier,zirconium oxide.ENDOSEAL MTA was also chosendue to the presence of calciumsulfate and to share the sameintended use and delivery system(ready-to-use syringe). |
| Principle ofoperation | BIO-C SEALER ION+ is an insolubleand radiopaque root canal sealerwhich requires the presence of waterto set and harden.Calcium, magnesium and silicon ionsare released in the presence ofmoisture. The calcium sulfate inpresence of moisture produces SO42-and Ca2+ ions. The sulfate anions(SO42-) will combine with H+ from thewater, increasing the concentrationof OH- in the surroundings and thepH of the medium. | BIO-C SEALER is an insoluble andradiopaque root canal sealer whichrequires the presence of water to setand harden. Calcium hydroxide isproduced due to the hydrationreaction of the calcium silicates andcalcium oxide, increasing the pH ofthe medium. | The inside of the root canal systemhas high humidity due to residualmoisture in the dentinal tubules.MTA solidifies into a hard structureby absorbing the moisture from thesurrounding tissue.Calciumhydroxide is produced due to thehydration reaction of the calciumsilicates increasing the pH of themedium. | All materials are insolubleradiopaque root canal sealers whichrequire the presence of water to setand harden. |
| Indications for use | Sealing the root canal of permanentteeth;Internal reabsorption treatment. | Sealing the root canal of permanentteeth;Internal reabsorption treatment. | Permanent obturation of the rootcanal following root canal treatment. | Equivalent |
| Delivery form | Single paste | Single paste | Single paste | Equivalent |
| Design | SyringeDisposable Intra Canal tips | SyringeDisposable Intra Canal tips | SyringeDisposable Intra Canal tips | Equivalent |
| Nature of contact | Category: External communicatingdeviceContact: Tissue, bone and dentinContact Duration: C - Permanent(>30 days) | Category: External communicatingdeviceContact: Tissue, bone and dentinContact Duration: C - Permanent(>30 days) | Category: External communicatingdeviceContact: Tissue, bone and dentinContact Duration: C - Permanent(>30 days) | Equivalent |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Equivalent |
| pH | 10.5 | 12.5 | Unknown | Equivalent to BIO-C SEALER.Unavailable for ENDOSEAL MTA. |
| Setting time | 120-240 minutes | 120-240 minutes | 12.31 minutes | All products will set in presence ofwater, however, according tomanufacture, ENDOSEAL MTApresents a faster setting time. |
| Radiopacity | $\ge 7$ mm Al | $\ge 7$ mm Al | 10.5 mm Al | Equivalent |
| Biocompatibility | Biocompatible according to ISO10993-1:2009. | Biocompatible according to ISO10993-1:2009. | - | Equivalent |
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NON-CLINICAL PERFORMANCE TESTING
BIO-C SEALER ION* has undergone extensive bench testing. The following bench tests were performed according to ISO 6876:2012 Dental root canal sealing materials: setting time, solubility, flow, film thickness and radiopacity. Additional tests are also performed and incorporated into the product acceptance criteria: X-ray diffraction analysis, particle size analysis, viscosity and thixotropy tests and color determination analysis.
Biocompatibility tests were conducted with the subject device according to ISO 10993-1:2009 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process providing evidence that BIO-C SEALER ION+ is non-mutagenic, non-irritant to oral mucosa of hamsters, no sensitizing and has met the requirements of absence of acute systemic toxicity after single oral administration.
CLINICAL PERFORMANCE TESTING
Clinical performance testing was not conducted on the subject device.
CONCLUSION
Based upon a comparison of technology, non-clinical performance testing and similarity in intended use, we concluded that BIO-C SEALER ION* is substantially equivalent to the predicate devices.
§ 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.