(55 days)
Not Found
No
The device description focuses on the material composition and physical properties of a bioceramic paste for dental procedures. There is no mention of software, algorithms, or any computational processing that would indicate the use of AI or ML. The submission explicitly states that the device has not changed from its predicate devices and relies on previous testing and independent studies of those predicates, none of which are described as incorporating AI/ML.
Yes
The device is a bioceramic paste intended for various dental procedures such as root canal repair, pulp capping, and pulpotomy, which are therapeutic interventions.
No
The device description and intended use clearly state that it is a 'premixed bioceramic paste' for dental procedures such as 'repair of root perforation,' 'root end filling,' and 'pulp capping,' which are all treatment-oriented procedures, not diagnostic ones.
No
The device description clearly states that the devices are "a convenient ready-to-use fast setting white hydraulic premixed bioceramic paste" and are "packaged in a preloaded syringe" or "preloaded container," indicating they are physical materials and delivery systems, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (Repair of Root Perforation, Repair of Root Resorption, Root End Filling, Apexification, Pulp capping, Pulpotomy) are all procedures performed directly on the patient's tooth structure.
- Device Description: The device is described as a "hydraulic premixed bioceramic paste" used for "permanent root canal repair" and other dental applications. This is a material applied to the tooth, not a test performed on a sample from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to physically repair or fill parts of the tooth.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
-Repair of Root Perforation
-Repair of Root Resorption
-Root End Filling
-Apexification
-Pulp capping
-Pulpotomy of primary teeth in the children (ages >2-12 years) and adolescent (ages >12-21 years).
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
iRoot BP, iRoot FS, and iRoot BP Plus are a convenient ready-to-use fast setting white hydraulic premixed bioceramic paste. Which are developed for permanent root canal repair of root perorption, and root end filling, apexification and pulp capping applications in adult and pediatric cases. The aforementioned products are an insoluble, radiopaque and aluminum-free material based on a calcium slicate composition, which requires the presence of water to set and harden. The products do not shrink during setting and demonstrate excellent physical properties. Root BP is packaged in a preloaded syringe, iRoot BP Plus is packaged in a preloaded container and iRoot FS is available both in syringe and container form. The devices have not changed from their respective predicate devices of iRoot BP(K082943), iRoot BP Plus(K092715), and iRoot FS(K102867).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal / tooth
Indicated Patient Age Range
Adult and pediatric cases, specifically: children (ages >2-12 years) and adolescent (ages >12-21 years).
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)
This proposal does not change any qualities of Root BP, Root BP Plus, and iRootFS. As such, it is identical to the respective predicate devices iRoot BP(K082943), iRoot BP Plus(K092715), and iRoot FS(K102867). The tests performed on the predicates were valid, so no other testing was done. In the attachments is the previous bench testing done on the submission of the predicate devices iRoot BP(K082943), iRoot BP Plus(K092715), and iRoot FS(K102867).
There were no clinical test that were performed by us at IBC. However iRoot BP Plus and its predecessors have been on the international market for over 10 years now. Due to this there are many independent third-party studies that have been performed on Root BP and iRoot BP Plus which show their equivalence to MTA(K142178) for the purposes of pediatric applications as well as their safety and effectiveness in that specific use. The summaries of some of these studies are attached in the References section of this submission.
As the qualities of the proposed devices iRoot BP, iRoot BP Plus, and iRootFS have not changed from their respective predicate devices Root BP(K082943), Root BP Plus(K092715), and Root FS(K102867), they still strictly abide by the ISO 6876 and ANSI/ADA No. 57 and are also backed up by many independent third party clinical studies. With this we can conclude that the proposed the devices are both safe and effective as well as performing as well if not better then MTA(K142178).
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.
K142178, K082943, K092715, K102867
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.
Not Found
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 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.
November 22, 2022
Innovative BioCeramix Inc. % Quanzu Yang CEO Innovative BioCeramix, Inc. 101-8218 North Fraser Way Burnaby, V3N039 CANADA
Re: K222992
Trade/Device Name: iRoot BP Root Repair Material BioAggregate Paste, iRoot FS Fast Set Root Repair Material, iRoot BP Plus Root Repair Material Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF. Dated: September 28, 2022 Received: September 28, 2022
Dear Quanzu Yang:
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.
1
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
iRoot BP Root Repair Material BioAggregate Paste;
iRoot FS Fast Set Root Repair Material ;
iRoot BP Plus Root Repair Material
Indications for Use (Describe)
-Repair of Root Perforation
-Repair of Root Resorption
-Root End Filling
-Apexification
-Pulp capping
-Pulpotomy of primary teeth in the children (ages >2-12 years) and adolescent (ages >12-21 years).
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
| 510(k) Summary | Prepared on: 2022-09-22 | |||||
|---|---|---|---|---|---|---|
| Contact Details | K222992 | 21 CFR 807.92(a)(1) | ||||
| Applicant Name | Innovative BioCeramix, Inc. | |||||
| Applicant Address | 101 - 8218 North Fraser Way Burnaby BC V3N0E9 Canada | |||||
| Applicant Contact Telephone | 6042216800 | |||||
| Applicant Contact | Dr. Quanzu Yang | |||||
| Applicant Contact Email | quanzu@ibioceramix.com | |||||
| Device Name | 21 CFR 807.92(a)(2) | |||||
| Device Trade Name | iRoot BP Root Repair Material BioAggregate Paste; | |||||
| iRoot FS Fast Set Root Repair Material; | ||||||
| iRoot BP Plus Root Repair Material | ||||||
| Common Name | Root canal filling resin | |||||
| Classification Name | Resin, Root Canal Filling | |||||
| Regulation Number | 872.3820 | |||||
| Product Code | KIF | |||||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||||
| K142178 | ProRoot MTA | KIF | ||||
| K082943 | iRoot BP | KIF | ||||
| K092715 | iRoot BP Plus | KIF | ||||
| K102867 | iRoot FS | KIF |
Device Description Summary
iRoot BP, iRoot FS, and iRoot BP Plus are a convenient ready-to-use fast setting white hydraulic premixed bioceramic paste. Which are developed for permanent root canal repair of root perorption, and root end filling, apexification and pulp capping applications in adult and pediatric cases. The aforementioned products are an insoluble, radiopaque and aluminum-free material based on a calcium slicate composition, which requires the presence of water to set and harden. The products do not shrink during setting and demonstrate excellent physical properties. Root BP is packaged in a preloaded syringe, iRoot BP Plus is packaged in a preloaded container and iRoot FS is available both in syringe and container form. The devices have not changed from their respective predicate devices of iRoot BP(K082943), iRoot BP Plus(K092715), and iRoot FS(K102867).
Intended Use/Indications for Use
-Repair of Root Perforation -Repair of Root Resorption -Root End Filling
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(4)
4
-Apexification
-Pulp capping
-Pulpotomy of primary teeth in the children (ages >2-12 years) and adolescent (ages > 12-21 years).
Indications for Use Comparison
For the indications for use of the devices iRoot BP Plus, and iRoot FS we are claiming substantial equivalence to the primary predicate device ProRoot MTA(K142178) as they have the same intended use. The indications for use of Plus, and Root FS differ from the predicate devices Root BPK082943), Root BP Plus/K092715), and iRoot FS(K102867). We are adding the use for the pulpotomy of primary teeth in children and adolescents. Since the new indication for use of the device only adds a new age group that the device can be used on with the existing functionality of pulpotomy/pulp capping it does not change the intended use of the device.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
The use of iRoot Bp, iRoot BP Plus, and iRoot FS in the pulpotorny of primary teeth has been studied in many pieces of independent third-party, peer reviewed published medical literature. These studies covered by this application are substantially equivalent to ProRoot MTA(K142178) in safety and effectiveness for the use on pediations. As such we judged it appropriate to add the pulpotomy of primary teeth in children and adolescents as an indication for use. The studies are included in the References section of this application
Technological Comparison
For the technological characteristics of the devices iRoot BP Plus, and iRoot FS we are claiming substantial equivalence with the predicate devices Root BP(K082943), iRoot BP Plus(K092715), and Root FS(K102867) respectively. The devices covered in this application are identical to their corresponding predicate devices as reason for this application is only to change the indication for use to support pediatric populations.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
This proposal does not change any qualities of Root BP, Root BP Plus, and iRootFS. As such, it is identical to the respective predicate devices iRoot BP(K082943), iRoot BP Plus(K092715), and iRoot FS(K102867). The tests performed on the predicates were valid, so no other testing was done. In the attachments is the previous bench testing done on the submission of the predicate devices iRoot BP(K082943), iRoot BP Plus(K092715), and iRoot FS(K102867).
There were no clinical test that were performed by us at IBC. However iRoot BP Plus and its predecessors have been on the international market for over 10 years now. Due to this there are many independent third-party studies that have been performed on Root BP and iRoot BP Plus which show their equivalence to MTA(K142178) for the purposes of pediatric applications as well as their safety and effectiveness in that specific use. The summaries of some of these studies are attached in the References section of this submission.
As the qualities of the proposed devices iRoot BP, iRoot BP Plus, and iRootFS have not changed from their respective predicate devices Root BP(K082943), Root BP Plus(K092715), and Root FS(K102867), they still strictly abide by the ISO 6876 and ANSI/ADA No. 57 and are also backed up by many independent third party clinical studies. With this we can conclude that the proposed the devices are both safe and effective as well as performing as well if not better then MTA(K142178).