(283 days)
K172701 BIO-C SEALER
K170175 ENDOSEAL MTA
No
The description focuses on the material properties and physical characteristics of a bioceramic root canal sealer. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a root canal sealer used for sealing and treating internal reabsorption, which are therapeutic interventions.
No
This device is a material used for sealing root canals and treating internal reabsorption. It does not perform a diagnostic function by identifying or characterizing a disease or condition.
No
The device description clearly states it is a "ready-to-use injectable bioceramic root canal sealer" provided in a syringe with disposable tips, indicating it is a physical material and delivery system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The description clearly states that BIO-C SEALER ION* is a material used for sealing the root canal of permanent teeth and for internal reabsorption treatment. This is a therapeutic and restorative function performed directly on the patient's body, not an examination of a specimen outside the body.
- Intended Use: The intended use is to seal root canals and treat internal reabsorption, which are clinical procedures performed within the patient's mouth.
- Lack of Specimen Examination: There is no mention of examining any biological specimens (like blood, urine, tissue, etc.) derived from the patient.
Therefore, BIO-C SEALER ION* is a medical device, but it falls under the category of a dental material used for treatment within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
-
Sealing the root canal of permanent teeth;
-
Internal reabsorption treatment;
Product codes (comma separated list FDA assigned to the subject device)
KIF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal of permanent teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing was conducted according to ISO 6876:2012 Dental root canal sealing materials, for setting time, solubility, flow, film thickness and radiopacity. Additional tests include X-ray diffraction analysis, particle size analysis, viscosity and thixotropy tests and color determination analysis.
Biocompatibility tests were conducted 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 was not conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K172701 BIO-C SEALER
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.
K170175 ENDOSEAL MTA
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 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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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/A |
| Rua Waldir Landgraf, 101 | |
| Londrina, PR 86031-218 Brazil | |
| Telephone: +55 (43) 2101-3200 | |
| Fax: +55 (43) 2101-3201 | |
| Official Contact: | Juliana Norder Trostdorf |
| International 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 de |
| Produtos 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 SEALER | |
| ION+ | • 4 preloaded syringes with 0.5g each | |
| • 20 disposable intracanal tips | ||
| 3845 | BIO-C SEALER | |
| ION+ | • 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 the
Differences |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | BIO-C SEALER ION+ | BIO-C SEALER | ENDOSEAL MTA | |
| Manufacturer | ANGELUS
INDÚSTRIA
DE
PRODUTOS ODONTOLÓGICOS S/A | ANGELUS
INDÚSTRIA
DE
PRODUTOS ODONTOLÓGICOS S/A | MARUCHI | |
| Device Description | BIO-C SEALER ION+ is a ready-to-
use injectable endodontic
bioceramic Sealer, suitable for
obturation of root canals. | BIO-C SEALER is a ready-to-use
injectable endodontic bioceramic
Sealer, suitable for obturation of root
canals. | ENDOSEAL MTA is an endodontic
sealer based on MTA, providing a
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. | All three materials are ready-to-use
pastes intended for permanent
obturation of the root canal. 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. |
| Composition | Calcium and magnesium silicate
Zirconium oxide
Silicon oxide
Potassium sulfate
Calcium sulfate
Dispersing agent | Calcium silicates
Calcium oxide
Silicon oxide
Zirconium oxide
Iron oxide
Dispersing agent | Calcium silicates
Calcium aluminates
Calcium aluminoferrite
Zirconium oxide
Calcium sulfates
Thickening agent | 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. They
all share the same radiopacifier,
zirconium oxide.
ENDOSEAL MTA was also chosen
due to the presence of calcium
sulfate and to share the same
intended use and delivery system
(ready-to-use syringe). |
| Principle of
operation | BIO-C SEALER ION+ is an insoluble
and radiopaque root canal sealer
which requires the presence of water
to set and harden.
Calcium, magnesium and silicon ions
are released in the presence of
moisture. The calcium sulfate in
presence of moisture produces SO42-
and Ca2+ ions. The sulfate anions
(SO42-) will combine with H+ from the
water, increasing the concentration
of OH- in the surroundings and the
pH of the medium. | BIO-C SEALER is an insoluble and
radiopaque root canal sealer which
requires the presence of water to set
and harden. Calcium hydroxide is
produced due to the hydration
reaction of the calcium silicates and
calcium oxide, increasing the pH of
the medium. | The inside of the root canal system
has high humidity due to residual
moisture in the dentinal tubules.
MTA solidifies into a hard structure
by absorbing the moisture from the
surrounding tissue.
Calcium
hydroxide is produced due to the
hydration reaction of the calcium
silicates increasing the pH of the
medium. | All materials are insoluble
radiopaque root canal sealers which
require the presence of water to set
and harden. |
| | | | | |
| Indications for use | Sealing the root canal of permanent
teeth;
Internal reabsorption treatment. | Sealing the root canal of permanent
teeth;
Internal reabsorption treatment. | Permanent obturation of the root
canal following root canal treatment. | Equivalent |
| Delivery form | Single paste | Single paste | Single paste | Equivalent |
| Design | Syringe
Disposable Intra Canal tips | Syringe
Disposable Intra Canal tips | Syringe
Disposable Intra Canal tips | Equivalent |
| Nature of contact | Category: External communicating
device
Contact: Tissue, bone and dentin
Contact Duration: C - Permanent
(>30 days) | Category: External communicating
device
Contact: Tissue, bone and dentin
Contact Duration: C - Permanent
(>30 days) | Category: External communicating
device
Contact: Tissue, bone and dentin
Contact 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 of
water, however, according to
manufacture, ENDOSEAL MTA
presents a faster setting time. |
| Radiopacity | $\ge 7$ mm Al | $\ge 7$ mm Al | 10.5 mm Al | Equivalent |
| Biocompatibility | Biocompatible according to ISO
10993-1:2009. | Biocompatible according to ISO
10993-1:2009. | - | 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.