(90 days)
No
The device description and performance studies focus on the material properties and biocompatibility of a bioceramic sealer, with no mention of AI or ML capabilities.
No
This device is a sealer used for permanent obturation of the root canal after pulp procedures, not a therapeutic device that actively treats disease.
No
This device is a bioceramic sealer used for permanent obturation and filling of the root canal, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a "premixed ready-to-use, injectable white hydraulic bioceramic paste" and is "packaged in an oral irrigator and is supplied with disposable Intra Canal Tips." This indicates 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 devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The i-MTA SP Injectable Root Canal Bioceramic Sealer is a material used to physically fill and seal the root canal within a tooth. It is applied directly to the anatomical site (the root canal) and does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use is for permanent obturation (filling) of the root canal, which is a therapeutic procedure, not a diagnostic one.
- Device Description: The description clearly states it's a "hydraulic bioceramic paste developed for permanent root canal filling and sealing applications."
- Performance Studies: The performance studies listed (ISO 6876, ISO 7405, ISO 10993-1) are related to the physical properties, biocompatibility, and performance of a dental material used within the body, not the analytical performance of a diagnostic test.
Therefore, the i-MTA SP Injectable Root Canal Bioceramic Sealer is a medical device used in dentistry for a therapeutic purpose, 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.
i-MTA SP Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and placement of intracanal dressings.
Product codes
KIF
Device Description
i-MTA SP Injectable Root Canal Bioceramic Sealer is a convenient premixed ready-to-use, injectable white hydraulic bioceramic paste developed for permanent root canal filling and sealing applications. an injectable mineral trioxide aggregate. i-MTA SP is used for root canal sealing and permanent obturation. It is an insoluble and radiopaque material based on a calcium silicates composition, which requires the presence of water to set and harden. i-MTA SP is packaged in an oral irrigator and is supplied with disposable Intra Canal Tips. i-MTA SP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal following vital pulp-extirpation
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)
The following performance data were provided in support of the substantial equivalence determination.
- ISO 6876:2012 Dentistry - Root canal sealing materials.
-Endodontic usage Test- ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
-Biocompatibility Assessment per FDA Biocompatibility Guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Summary:
Injectable Root Canal Bioceramic Sealer has the same Indications for Use and the principle of operations as the predicate device and reference device. It is intended purpose as they are placed into the root canal as a root filling materials which met the requirement according to ISO 6876. It has similar physical and biocompatible properties and demonstrates comparable performance specifications to the predicate devices.
The chemical compositions might slightly different from the predicate devices, both are used calcium silicate as base material, and additional components are used to improve flowability. The bench and biocompatibility testing performed demonstrates that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. Therefore, it is concluded that i-MTA SP is substantially equivalent to the predicate devices. Hence, its equivalent is acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Image /page/0/Picture/0 description: The image contains 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 3, 2024
Longly Biotechnology (wuhan) CO., LTD % Alice Wu RA Manager Wuhan Tacro Technology Co., Ltd. 2F, Bldg. A21, Biolake, No.666 Gaoxin Ave East Lake High-tech Development Zone Wuhan, Hubei 430070 CHINA
Re: K241977
Trade/Device Name: Injectable Root Canal Bioceramic Sealer (i-MTA SP) Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: May 10, 2024 Received: July 5, 2024
Dear Alice Wu:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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, MChE, RAC, CQIA 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Injectable Root Canal Bioceramic Sealer (i-MTA SP)
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.
i-MTA SP Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone 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)
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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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary K241977
''510(k) Summary'' as required by 21 CFR Part 807.92.
Date: 2024-10-03
I. Submitter
Longly Biotechnology (Wuhan) Co, Ltd
No.02, 2nd Floor, Building A2-2, Optics Valley Biomedical Park, Gaoxin Avenue No.858, East Lake
High-tech Development Zone, 430070, Wuhan, Hubei, China
Tel.: 86+13907166169
Yan Liang (Registration manager) Tel: +86 13907166169 Email: longlyyanliang466@163.com
II. Correspondent Consultant
Wuhan Tacro Technology Co.,Ltd. 2F, Bldg. A21, Biolake, No. 666 Gaoxin Ave, East Lake High-tech Development Zone, Wuhan, Hubei, P.R.China
Alice Wu (RA manager) Tel: +86 15171490719 Email: ddwu@tacro.cn
III. Device
Type of 510(k): Traditional
Common Name: Injectable Root Canal Bioceramic Sealer
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| Title | Tab 16: 510(k) Summary | Page: | 2 of 8 |
|---|---|---|---|
| ------- | ------------------------ | ------- | -------- |
Trade Name: Injectable Root Canal Bioceramic Sealer Model: i-MTA SP Regulation Name: Root Canal Filling Resin Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Review Panel: General & Plastic Surgery Regulatory Class: II Product Code: KIF- Resin, Root Canal Filling
IV. Predicate Device
| Device | Primary predicate device | Reference device |
|---|---|---|
| 510 k number | K212983 | K080917 |
| Trade Name | Injectable Root Canal Bioceramic | |
| Sealer | iRoot SP Root Canal Sealer | |
| Model | C-Root SP | iRoot SP |
| Manufacturer | Beijing C-Root Dental Medical Devices | |
| Co., LTD. | Innovative BioCeramix Incorporated | |
| Classification | II | II |
| Regulation Number | 21 CFR 872.3820 | 21 CFR 872.3820 |
| Product Code | KIF | KIF |
V. Device Description
i-MTA SP Injectable Root Canal Bioceramic Sealer is a convenient premixed ready-to-use, injectable white hydraulic bioceramic paste developed for permanent root canal filling and sealing applications. an injectable mineral trioxide aggregate. i-MTA SP is used for root canal sealing and permanent obturation. It is an insoluble and radiopaque material based on a calcium silicates composition, which requires the presence of water to set and harden. i-MTA SP is packaged in an
6
| Title | Tab 16: 510(k) Summary | Page: | 3 of 8 |
|---|---|---|---|
| ------- | ------------------------ | ------- | -------- |
oral irrigator and is supplied with disposable Intra Canal Tips. i-MTA SP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods.
VI. 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.
i-MTA SP Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and placement of intracanal dressings.
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4 of 8
VII.Comparison of Technological Characteristics With the Predicate Device
i-MTA SP Injectable Root Canal Bioceramic Sealer raises no safety or efficacy concerns when compared to the predicate devices.
A technical comparison to the predicate is provided below:
| Comparison Elements | Subject Device | Predicate Device | Reference device |
|---|---|---|---|
| K Number | Applying K241977 | K212983 | K080917 |
| Trade name | Injectable Root Canal Bioceramic Sealer | Injectable Root Canal Bioceramic Sealer | iRoot SP Root Canal Sealer |
| Model | i-MTA SP | C-Root SP | iRoot SP |
| Classification name | Root Canal Filling Resin | Root Canal Filling Resin | Root Canal Filling Resin |
| Product code | KIF | KIF | KIF |
| 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 | Permanent obturation of the root canal following vital pulp-extirpation
Permanent obturation of the root canal following removal of infected or necrotic pulp and | 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 |
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| Title | Tab 16: 510(k) Summary | Page: | 5 of 8 |
|---|---|---|---|
| ------- | ------------------------ | ------- | -------- |
| Comparison Elements | Subject Device | Predicate Device | Reference device |
|---|---|---|---|
| placement of intracanal dressings. | |||
| i-MTA SP Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and lateralcondensation technique. | |||
| placement of intracanal dressings. | placement of intracanal dressings. | ||
| C-Root SP Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and lateralcondensation technique. | |||
| condensation technique. | intracanal dressings. | ||
| iRoot SP is suitable for use in the single cone and lateralcondensation technique. | |||
| Targeted anatomic site | Root canal following vital pulp-extirpation | Root canal following vital pulp-extirpation | Root canal following vital pulp-extirpation |
| Targeted population | Human tooth root canal | Human tooth root canal | Human tooth root canal |
| Prescription Use | Yes | Yes | Yes |
| Basic Chemical Composition | Zirconium Oxide, | ||
| Calcium Silicates, | |||
| Calcium Phosphates, | |||
| Calcium Hydroxide, | |||
| Polyethylene glycol, | |||
| Hydroxypropyl methyl cellulose | Zirconium Oxide, | ||
| Strontium Silicates, | |||
| Calcium Phosphates, | |||
| Calcium Hydroxide, | |||
| Tantalum Oxide and Filler Agents. | Zirconium oxide, | ||
| Calcium silicate, | |||
| Calcium hydroxide, | |||
| Calcium phosphate, | |||
| Monobasic and Filler Agents | |||
| Performance Standard Conformance | Conformed to ISO 6876 and Technical Requirements., adding Appearance, Size change after curing. | Conformed to ISO 6876. and conformed to Technical Requirements of "Injectable Root Canal Bioceramic Sealer" adding | Conformed to ISO 6876. |
9
| Title | Tab 16: 510(k) Summary | Page: | 6 of 8 |
|---|---|---|---|
| ------- | ------------------------ | ------- | -------- |
| Comparison Elements | Subject Device | Predicate Device | Reference device |
|---|---|---|---|
| Appearance, Dimensional | |||
| change following setting, pH. | |||
| Duration of Contact | Permanent contact - contact exceeds 30d | Permanent contact - contact exceeds 30d | Permanent contact - contact exceeds 30d |
| Biocompatibility | Biocompatibility Assessment per FDA | ||
| Biocompatibility Guidance Use of International | |||
| Standard ISO 10993-1, Biological evaluation of | |||
| medical devices - Part 1: Evaluation and testing | |||
| within a risk management process. | Comply with ISO 10993-1:2018, FDA Guidance, | ||
| tests included cytotoxicity, irritation, sensitization, | |||
| acute systemic toxicity, subchronic systemic toxicity | |||
| test, implantation effect, endodontic usage test, Ames | |||
| test and TK test. | Biocompatibility Assessment per FDA | ||
| Biocompatibility Guidance Use of International | |||
| Standard ISO 10993-1 |
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Performance Data VIII.
The following performance data were provided in support of the substantial equivalence determination.
- ISO 6876:2012 Dentistry - Root canal sealing materials.
-Endodontic usage Test- ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
-Biocompatibility Assessment per FDA Biocompatibility Guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Summary
Injectable Root Canal Bioceramic Sealer has the same Indications for Use and the principle of operations as the predicate device and reference device. It is intended purpose as they are placed into the root canal as a root filling materials which met the requirement according to ISO 6876. It has similar physical and biocompatible properties and demonstrates comparable performance specifications to the predicate devices.
VIII. Conclusions
Injectable Root Canal Bioceramic Sealer has the same Indications for Use and the principle of operations as the predicate device and reference device. It is intended purpose as they are placed into the root canal as a root filling material which met the requirement according to ISO 6876. It has similar physical and biocompatible properties and demonstrates comparable performance specifications to the predicate equivalent is acceptable.
The chemical compositions might slightly different from the predicate devices, both are used
11
| Title | Tab 16: 510(k) Summary | Page: 8 of 8 |
|---|---|---|
| ------- | ------------------------ | -------------- |
calcium silicate as base material, and additional components are used to improve flowability. The bench and biocompatibility testing performed demonstrates that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. Therefore, it is concluded that i-MTA SP is substantially equivalent to the predicate devices. Hence, its equivalent is acceptable.