(30 days)
No
The description focuses on the material composition and physical properties of a root canal sealer, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a root canal sealer used for permanent obturation, filling a void rather than treating a disease or condition.
No
The device is described as a "Root Canal Sealer" used for "permanent obturation of the root canal," which means it fills and seals the root canal. This is a therapeutic or restorative function, not a diagnostic one.
No
The device description clearly states it is a "hydraulic cement paste" packaged in a "pre-loaded syringe" and supplied 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:
- Intended Use: The intended use is for the permanent obturation (filling and sealing) of the root canal. This is a therapeutic procedure performed directly on the patient's tooth, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a material (hydraulic cement paste) used to fill a physical space within the tooth. It doesn't analyze biological samples or provide diagnostic information.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as analyzing blood, urine, tissue, or other bodily fluids, or providing information for the diagnosis, monitoring, or treatment of a disease or condition based on such analysis.
Therefore, the iRoot SP Plus Root Canal Sealer is a medical device used for a therapeutic purpose in dentistry, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Permanent obturation of the root canal following vital pulp-extirpation
- Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
iRoot SP Plus Root Canal Sealer (iRoot SP Plus) is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. iRoot SP Plus 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 SP Plus demonstrates substantially equivalent physical properties to iRoot SP. iRoot SP Plus is packaged in a pre-loaded syringe and is supplied with disposable Tips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal
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)
No Clinical tests were done specifically for this submission however, the predicate device iRoot SP has safetly been on the market since 2008 with over a million of global sales. iRoot SP also has clinical studies that have spanned up to four years in time over hundreds of clinical cases, which concluded that iRoot SP is safe and effective for use on patients. The non-clinical tests, based on ISO 6876 Third edition 2012-06-01, performed on both iRoot SP and iRoot SP Plus have shown that iRoot SP Plus is substantially equivalent to iRoot SP. Based on the evidence provided by the clinical and non-clinical tests we can say that iRoot SP Plus is safe and effective.
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.
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.
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
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May 31, 2023
Innovative BioCeramix, Inc. Quanzu Yang CEO 8218 North Fraser Way Rm 101 Burnaby, BC V3N0E9 CANADA
Re: K231259
Trade/Device Name: iRoot SP Plus Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: April 18, 2023 Received: May 1, 2023
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 SP Plus
Indications for Use (Describe)
· Permanent obturation of the root canal following vital pulp-extirpation
| • Permanent obturation of the root canal following removal of infected or necrotic pulp and |
|---|
| placement of intracanal dressings. |
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
Image /page/3/Picture/0 description: The image shows the logo for Innovative BioCeramix Inc. The logo consists of the letters "IBC" in a stylized font, followed by the words "Innovative BioCeramix Inc." in a serif font. The letters "IBC" are in a teal color, while the rest of the text is in black. The logo is simple and professional, and it conveys the company's focus on innovation and bioceramics.
510(k) SUMMARY - K231259
Contact Details
Applicant Name: Innovative BioCeramix Inc. Applicant Address: 8218 North Fraser Way RM 101 Burnaby BC V3N0E9 Canada Applicant Contact Telephone: (604)-221-6800 Applicant Contact: Dr. Quanzu Yang Applicant Contact Email: quanzu@ibioceramix.com
Device Name
Device Trade Name: iRoot SP Plus Common Name: Root canal filling resin Classification Name: Resin. Root Canal Filling Regulation Number: 872.3820 Product Code: KIF 510(k) Number: K231259
Legally Marketed Predicate Device
| Predicate # | Predicate Trade name | Product
Code |
|-------------|----------------------|-----------------|
| K080917 | iRoot SP | KIF |
Legally Marketed Reference Devices
| Reference # | Reference Trade name | Product Code |
|---|---|---|
| K082943 | iRoot BP | KIF |
| K032605 | Metapaste Calcium Hydroxide With Barium Sulfate Temporary | |
| Root Canal Filling | KIF | |
| K103190 | ProFil Composites | EBF |
Device Description Summary
iRoot SP Plus Root Canal Sealer (iRoot SP Plus) is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. iRoot SP Plus 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 SP Plus demonstrates substantially equivalent physical properties to iRoot SP. iRoot SP Plus is packaged in a pre-loaded syringe and is supplied with disposable Tips.
4
Indications For Use
- Permanent obturation of the root canal following vital pulp-extirpation
- · Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
Indications For Use Comparison
The indications for use of iRoot SP Plus are equivalent to its primary predicate device of iRoot SP
Technological Comparison
iRoot SP Plus modifies iRoot SP by adding two additional materials to the primary predicate device. One of which is 3-(Trimethoxysilyl)propyl methacrylate, used as a coupling agent, for which we draw substantial equivalence with the reference device iRoot BP. The other being Barium silicate which will increase the radiopacity of the device, for which we draw substantial equivalence with the Barium Silicate found in the reference device ProFil and the Barium sulfate found in the reference device Metapaste.
Non-Clinical and/or Clinical Tests Summary & Conclusions
No Clinical tests were done specifically for this submission however, the predicate device iRoot SP has safetly been on the market since 2008 with over a million of global sales. iRoot SP also has clinical studies that have spanned up to four years in time over hundreds of clinical cases, which concluded that iRoot SP is safe and effective for use on patients. The non-clinical tests, based on ISO 6876 Third edition 2012-06-01, performed on both iRoot SP and iRoot SP Plus have shown that iRoot SP Plus is substantially equivalent to iRoot SP. Based on the evidence provided by the clinical and non-clinical tests we can say that iRoot SP Plus is safe and effective.