(119 days)
No
The summary describes a bioceramic sealer for root canals and its physical-chemical properties, with no mention of AI or ML technology.
Yes.
The device is used for "sealing the root canal of permanent teeth" and "internal reabsorption treatment," which are therapeutic interventions.
No
The device description and intended use indicate it is an endodontic sealer for obturation and treatment, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is an "injectable endodontic bioceramic sealer," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Sealing the root canal of permanent teeth" and "Internal reabsorption treatment." These are procedures performed on the patient's body (in vivo), not tests performed on samples taken from the body (in vitro).
- Device Description: The device is described as an "injectable endodontic bioceramic sealer, suitable for obturation of root canals." This is a material used to fill and seal the root canal space within the tooth.
- Lack of Diagnostic Purpose: There is no mention of this device being used to diagnose a condition, measure a substance in a sample, or provide information about a patient's health status based on testing a sample.
IVD devices are typically used to examine specimens derived from the human body, such as blood, urine, tissue, etc., to provide information for diagnosis, monitoring, or screening. This device is a therapeutic material used directly in a dental procedure.
N/A
Intended Use / Indications for Use
-
- Sealing the root canal of permanent teeth;
-
- Internal reabsorption treatment.
Product codes
KIF
Device Description
BIO-C SEALER is a ready-to-use injectable endodontic bioceramic sealer, suitable for obturation of root canals.
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
Bench tests performed are: flow, setting time, film thickness, solubility and radiopacity.
Results: Both devices have comparable flowability, setting time, film thickness, solubility and radiopacity.
The biocompatibility evaluation provide evidence that the product is non-mutagenic, does not cause an allergenic potential after multiple uses and has a good tolerance.
Key Metrics
Not Found
Predicate Device(s)
K080917 iRoot SP (Innovative BioCeramix Inc.)
Reference Device(s)
K140247 MTA-FILLAPEX (Angelus Indústria de Produtos Odontológicos S/A), K151047 MTA REPAIR HP cleared under (Angelus Indústria de Produtos Odontológicos S/A)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Angelus Industria de Produtos Odontologicos S/A Juliana Norder International Regulatory Affairs Analyst Rua Waldir Landgraf, 101 Londrina, 86.031-218 BRAZIL
January 4, 2018
Re: K172701
Trade/Device Name: Bio-C Sealer Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: October 12, 2017 Received: October 12, 2017
Dear Juliana Norder:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner
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For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name BIO-C SEALER
Indications for Use (Describe)
- Sealing the root canal of permanent teeth; 1.
-
- 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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K172701
510(k) Summary
Angelus Indústria de Produtos Odontológicos S/A
BIO-C SEALER
August 28, 2017
ADMINISTRATIVE INFORMATION
| 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 |
International Regulatory Affairs Analyst juliana.norder@angelus.ind.br
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | BIO-C SEALER |
|---|---|
| Common Name: | Root Canal Filling Resin |
| Classification Regulation: | 21 CFR 872-3820, Class II |
| Product Code: | KIF |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |
| Substantial Equivalence: | K080917 iRoot SP (Innovative BioCeramix Inc.) |
| For specific chemical compositions: | K140247 MTA-FILLAPEX (Angelus Indústria de |
| Produtos Odontológicos S/A) | |
| K151047 MTA REPAIR HP cleared under (Angelus | |
| Indústria de Produtos Odontológicos S/A) |
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INTENDED USE
-
- Sealing the root canal of permanent teeth;
-
- Internal reabsorption treatment.
DEVICE DESCRIPTION
BIO-C SEALER is a ready-to-use injectable endodontic bioceramic sealer, suitable for obturation of root canals.
EQUIVALENCE TO MARKETED DEVICE
Angelus Indústria de Produtos Odontológicos S/A demonstrated that, for the purposes of FDA's regulation of medical devices, BIO-C SEALER is substantially equivalent in indications and design principles to the following predicate device:
INNOVATIVE BIOCERAMIX INC., iRoot SP cleared under K080917
The subject device and the predicate device have the same intended use and have the same technological characteristics and are made of similar materials. They encompass the same range of physical and chemical properties. The subject and predicate devices are packaged in similar materials and use similar methods of application.
Any differences in the technological characteristics do not raise new issues of safety or effectiveness. Even though BIO-C SEALER's main chemical composition is based on iRoot SP, as mentioned above, the additional chemical components in BIO-C SEALER's composition were found in the following predicate devices:
ANGELUS INDÚSTRIA DE PRODUTOS ODONTOLÓGICOS S/A, MTA-FILLAPEX cleared under K140247 ANGELUS INDÚSTRIA DE PRODUTOS ODONTOLÓGICOS S/A, MTA REPAIR HP cleared under K151047 Therefore, it is concluded that BIO-C SEALER is substantially equivalent to the predicate devices.
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PERFORMANCE DATA OR NON-CLINICAL EVIDENCE
BIO-C SEALER has undergone extensive bench testing to provide evidence that its physical-chemical properties are substantially equivalent to iRoot SP. Bench tests performed are: flow, setting time, film thickness, solubility and radiopacity.
Both devices have comparable flowability, setting time, film thickness, solubility and radiopacity.
The biocompatibility evaluation provide evidence that the product is non-mutagenic, does not cause an allergenic potential after multiple uses and has a good tolerance.
CONCLUSION
BIO-C SEALER and its predicate device are designated for equivalent dental applications and have comparable chemical and physical properties and performance specifications. Furthermore, BIO-C SEALER and its predicate device have equivalent shelf life, packaging containers and delivery systems.
Based on the information provided in the premarket notification, we can conclude that the subject device is substantially equivalent to the predicate device.