(220 days)
No
The summary describes a bioceramic paste for endodontic procedures and provides performance data based on physical-chemical properties and bench testing. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes.
The device is a reparative cement intended for various endodontic treatments, directly treating complications like perforations, reabsorption, and pulp capping, which are conditions of disease or injury.
No
This device is a reparative cement used for various endodontic complications, such as treating perforations, reabsorption, and for retrofilling or pulp capping. It is a therapy/treatment device, not one that diagnoses a condition.
No
The device description clearly states it is a "ready-to-use bioceramic MTA-based paste" provided in a syringe, 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 used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states that BIO-C REPAIR is a "reparative cement for endodontic complications" and is applied "to the affected area of the root canal system." It's a material used within the body to repair tissue, not a device used to analyze samples outside the body.
- Intended Use: The listed intended uses are all related to repairing and treating issues within the tooth's root canal system, which are clinical procedures performed directly on the patient.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, BIO-C REPAIR is a therapeutic medical device used in dentistry, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Reparative cement for endodontic complications.
- Furcation or root perforation treatment via canal;
- Furcation or root perforation treatment via surgical;
- Internal reabsorption treatment via canal or surgical;
- External reabsorption treatment;
- Retrofilling in parendodontic surgery;
- Direct and indirect pulp capping;
- Apexification;
- Apexogenesis and Pulpotomy.
Product codes
KIF
Device Description
BIO-C REPAIR is a ready-to-use bioceramic MTA-based paste developed for permanent root canal repair and surgical applications. The product is a single paste provided in a syringe with disposable tips to be applied to the affected area of the root canal system. BIO-C REPAIR is an insoluble and radiopaque material which requires the presence of water to set and harden.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal system, Root, Pulp
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended users: Dental practitioners
Environment of use: Prescription / Hospital
Intended environment: Dental offices
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: Bench testing (physical-chemical properties)
Sample Size: Not specified
Key Results: BIO-C REPAIR has undergone extensive bench testing to provide evidence that its physical-chemical properties are substantially equivalent to iRoot BP. The following bench tests were performed according to ISO 6876:2012 Dental root canal sealing materials: setting time, solubility and radiopacity. Both devices are provided non-sterile and have comparable setting time, pH and radiopacity. Although we did not find the solubility of the predicate, our product when subjected to solubility tests presented values in accordance with the established by the international standard.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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 features 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 Br
Re: K180185
Trade/Device Name: BIO-C Repair Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: January 12, 2018 Received: January 23, 2018
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. 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 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
August 31, 2018
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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 -S
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name BIO-C REPAIR
Indications for Use (Describe)
-
- Furcation or root perforation treatment via canal;
-
- Furcation or root perforation treatment via surgical;
-
- Internal reabsorption treatment via canal or surgical;
-
- External reabsorption treatment;
-
- Retrofilling in parendodontic surgery;
-
- Direct and indirect pulp capping;
-
Apexification;
-
Apexogenesis and Pulpotomy.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Angelus Indústria de Produtos Odontológicos S/A
BIO-C REPAIR
August 31, 2018
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 |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | BIO-C REPAIR |
|---|---|
| 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 |
| Primary Predicate Device: | K082943 iRoot BP (Innovative BioCeramix Inc.) |
| Secondary Reference Device: | K172701 BIO-C SEALER (Angelus Indústria de Produtos odontológicos S.A) |
4
DEVICE DESCRIPTION
BIO-C REPAIR is a ready-to-use bioceramic MTA-based paste developed for permanent root canal repair and surgical applications. The product is a single paste provided in a syringe with disposable tips to be applied to the affected area of the root canal system. BIO-C REPAIR is an insoluble and radiopaque material which requires the presence of water to set and harden.
PRODUCT PRESENTATION
| Reference | Product Description | Package Contents |
|---|---|---|
| 3863 | BIO-C REPAIR | • 4 preloaded syringes with 0.5g each |
| • 20 disposable intracanal tips |
INTENDED USE
Reparative cement for endodontic complications.
INDICATIONS FOR USE
-
- Furcation or root perforation treatment via canal;
-
- Furcation or root perforation treatment via surgical;
-
- Internal reabsorption treatment via canal or surgical;
-
- External reabsorption treatment;
-
- Retrofilling in parendodontic surgery;
-
- Direct and indirect pulp capping;
-
- Apexification;
-
- Apexogenesis and Pulpotomy.
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 REPAIR is substantially equivalent in indications and design principles to the following predicate device:
INNOVATIVE BIOCERAMIX INC., iRoot BP cleared under K082943
5
The subject device and the predicate device have the same intended use and 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 specific components do not raise new issues of safety or efficacy. Even though BIO-C REPAIR's main chemical composition is based on iRoot BP, as mentioned above, the additional chemical components in BIO-C REPAIR's composition and the delivery system were found in the following predicate device:
ANGELUS INDÚSTRIA DE PRODUTOS ODONTOLÓGICOS S/A, BIO-C SEALER cleared under K172701.
COMPARISON TO THE CLEARED DEVICES
BIO-C REPAIR and iRoot BP are designated for the equivalent dental applications, have comparable chemical and physical properties and performance specifications. The secondary reference device, BIO-C SEALER, contains specific chemical components that are found in BIO-C REPAIR; providing evidence that these chemical components are safe and effective for medical device use and therefore does not affect the substantial equivalence. Furthermore, BIO-C REPAIR and BIO-C SEALER (K172701) have identical delivery systems (syringe and disposable intracanal tips).
The similarities and differences of BIO-C REPAIR and the predicates are discussed below:
-
BIO-C REPAIR, iRoot BP and BIO-C SEALER are mainly composed of tricalcium silicate and dicalcium silicate. These inqredients are responsible for physical and biological properties of both products.
-
Zirconium oxide is present in BIO-C REPAIR, iRoot BP and BIO-C SEALER compositions. This ingredient is responsible for the radiopacity of the products.
-
BIO-C REPAIR and BIO-C SEALER uses calcium oxide as Ca²+ an OH sources while iRoot BP relies only on calcium silicates to provide calcium and hydroxyl ions.
-
BIO-C REPAIR and BIO-C SEALER share the same dispersing agent, while iRoot BP does not discloses its carrier.
- く iRoot BP also contains calcium phosphate monobasic and tantalum pentoxide, unlike BIO-C REPAIR and BIO-C SEALER.
- BIO-C REPAIR, iRoot BP and BIO-C SEALER share the same Delivery System (syringe and > disposable intracanal tips).
6
Therefore, it is concluded that BIO-C REPAIR is substantially equivalent to the predicate devices.
The table below summarizes the main similarities of BIO-C REPAIR and the predicate devices:
| Element | Proposed Device | Predicate Device
(K082943) | Reference
Device |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | (K172701) |
| Trade Name | BIO-C REPAIR | iRoot BP | BIO-C SEALER |
| Manufacturer | ANGELUS INDÚSTRIA DE
PRODUTOS
ODONTOLÓGICOS S/A | INNOVATIVE BIOCERAMIX
INC. | ANGELUS INDÚSTRIA DE
PRODUTOS
ODONTOLÓGICOS S/A |
| Device Description | BIO-C REPAIR is a ready-
to-use bioceramic
reparative cement. | iRoot BP Injectable Root
Canal Repair Filling
Material is a convenient
ready-to-use white
hydraulic premixed
injectable paste developed
for permanent root canal
repair and filling
applications. | BIO-C SEALER is a ready-
to-use injectable
endodontic bioceramic
Sealer, suitable for
obturation of root canals. |
| Common Name | Root Canal Filling Resin | Root Canal Filling Resin | Root Canal Filling Resin |
| Class | Class II | Class II | Class II |
| Product Code | KIF | KIF | KIF |
| Composition | Calcium silicates
Calcium oxide
Zirconium oxide
Silicon oxide
Iron oxide
Dispersing agent | Tricalcium silicate
Dicalcium silicate
Calcium phosphate
monobasic
Zirconium oxide
Tantalum Pentoxide
Filler agents | Calcium silicates
Calcium oxide
Zirconium oxide
Silicon oxide
Iron oxide
Dispersing agent |
| Principle of
operation | BIO-C REPAIR is an
insoluble and radiopaque
root repair material 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. | iRoot BP is a ready-to-use
white hydraulic premixed
injectable paste developed
for permanent root canal
repair and filling
applications. iRoot
BP is an insoluble,
radiopaque and aluminum-
free material based on a
calcium silicate
composition, which
requires the presence of
water to set and harden.
iRoot BP does not shrink
during setting and is
packaged in a preloaded
syringe and is supplied
with disposable tips. | 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. |
| Indications for use | 1. Furcation or root
perforation treatment via
canal;
2. Furcation or root
perforation treatment via
surgical;
3. Internal reabsorption
treatment via canal or
surgical;
4. External reabsorption
treatment; | Repair of Root Perforation
Repair of Root Resorption
Root End Filling
Apexification
Pulp Capping | Sealing the root canal of
permanent teeth;
Internal reabsorption
treatment. |
| Delivery form | Single paste | Single paste | Single paste |
| Design | Syringe
Disposable Intra Canal tips | Syringe
Disposable Intra Canal tips | Syringe
Disposable Intra Canal tips |
| 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) |
| Sterile | Non-sterile | Non-sterile | Non-sterile |
| pH | 12.5 | > 12 | 12.5 |
| Setting time | 90 - 120 minutes | ~ 2 hours | 120-240 minutes |
| Radiopacity | $\ge$ 7 mm Al | ~ 7 mm Al | $\ge$ 7 mm Al |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |
| Contraindications | Do not use it in patients
that report sensitivity to
the components of the
formula. | Do not use in patients
with a known allergy to
any of the product's
ingredients. | Do not use it in patients
that report sensitivity to
the components of the
formula. |
| Shelf Life | 2 years | 2 years | 2 years |
| Environment of use | Prescription / Hospital | Prescription / Hospital | Prescription / Hospital |
| Intended
environment | Dental offices | Dental offices | Dental offices |
| Intended users | Dental practitioners | Dental practitioners | Dental practitioners |
| Intended patient
population | Patients who require
endodontic treatment. | Patients who require
endodontic treatment. | Patients who require
endodontic treatment. |
| Storage | Keep the product in a dry
and ventilated place
between 15 and 30°C and
with relative humidity
below 60%.
Do not store it in a
refrigerator.
Do not store the product
near ammonia,
ammonium nitrate and
products containing
chlorine. Avoid using
disinfectant solutions that
contain any of these
ingredients. | - Keep tightly closed in its
sealed package and store
it at room temperature in
a dry area, to avoid
moisture contact, which
could induce the setting
process.
- Be certain to tightly
secure the lid of the jar
after each use. - Use the syringe cap to
keep the syringe tightly
closed when not using the
material. - Do not use excessive
force to apply the material
into the root canal, as this
may cause acute pain to | Keep the product in a dry
and ventilated place
between 15 and 30°C and
with relative humidity
below 60%.
Do not store it in a
refrigerator.
Do not store the product
near ammonia,
ammonium nitrate and
products containing
chlorine. Avoid using
disinfectant solutions that
contain any of these
ingredients. |
7
8
PERFORMANCE DATA OR NON-CLINICAL EVIDENCE
BIO-C REPAIR has undergone extensive bench testing to provide evidence that its physical-chemical properties are substantially equivalent to iRoot BP. The following bench tests were performed according to ISO 6876:2012 Dental root canal sealing materials: setting time, solubility and radiopacity.
Both devices are provided non-sterile and have comparable setting time, pH and radiopacity. Although we did not find the solubility of the predicate, our product when subjected to solubility tests presented values in accordance with the established by the international standard.
CONCLUSION
BIO-C REPAIR and its predicate device are designated for equivalent dental applications and have comparable chemical and physical properties and performance specifications. Furthermore, BIO-C REPAIR 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.