(116 days)
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.
Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and lateral condensation technique.
NRSP 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. NRSP is an insoluble, radiopaque and aluminum-free material based on a strontium silicates composition, which requires the presence of water to set and harden. NRSP does not shrink during setting and demonstrates excellent physical properties. NRSP is packaged in a preloaded syringe and is supplied with disposable Intra Canal tips. NRSP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods. NRSP Injectable Root Canal Bioceramic Sealer is available in three preloaded syringe mode that provide different in specification in5g,3g,2g,1g and 0.5g. The only difference between the types are the net weight.
Root canal filling paste is a pre mixed paste material consisting of an inorganic powder system and an organic mixed liquid. It can solidify in a humoral environment, effectively seal the root tip, and has good biocompatibility; The curing time is stable and less affected by root canal moisture and humidity; It has excellent X-ray resistance, fluidity, antibacterial properties, non staining of teeth, and no irritation.
The provided document is a 510(k) premarket notification for a medical device called "Injectable Root Canal Bioceramic Sealer." It does not contain information about an AI/ML powered device or study results related to AI/ML performance.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI-powered device. The document primarily focuses on non-clinical bench testing and biocompatibility testing for a traditional medical device (root canal sealer) to demonstrate its substantial equivalence to a predicate device.
The tables and information presented are for the non-AI root canal sealer, for example:
- Table 1: Comparison to Predicate Device lists characteristics of the proposed device and its predicate, showing "Same" for many attributes like product code, regulation number, class, indications for use, chemical composition, and performance standard conformance.
- Table 2: Biocompatibility testing details various biocompatibility tests performed on the device (e.g., In Vitro Cytotoxicity, Skin sensitization, Ames test, Acute Systemic Toxicity Test, Bone implant test, Endodontic usage Test), all of which resulted in "Pass" for the "Proposed device."
Since the request is specifically about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML, and the document describes a non-AI medical device, I cannot fulfill the request as phrased.
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Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 28, 2024
Enpuno Biotechnology Co., Ltd Hao He General Manager No. 201, Haiping Park Production Plant3, No.229, Guyuan Road Changsha High-tech Development Zone Changsha City, Hunan 410205 CHINA
Re: K240304
Trade/Device Name: Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: April 29, 2024 Received: April 29, 2024
Dear Hao He:
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.
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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 (QS) 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.
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 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).
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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
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Indications for Use
Submission Number (if known)
Device Name
Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)
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.
Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and lateral condensation technique.
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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K240304 Section 4 - 510(k) Summary
Date of Summary Preparation: January 24, 2024 Update the Date: March 16 2024
1. Submitter's Identifications
Submitter's Name: Enpuno Biotechnology Co., Ltd Address: No. 201, Haiping Park Production Plant3, No.229, Guyuan Road Changsha High-tech Development Zone Changsha City, Hunan Province, China. Zip Code: 410205 Contact Person: Hao He Contact Title: General Manager Contact E-mail Address: 28241330@qq.com Tel: +86-731-84257959
2. Correspondent's Identifications
Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd.
Address: Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town, Huangpu District, Guangzhou City, Guangdong, 510663, China. ZIP Code: 510663 Contact Person: Shanfeng Jiang Contact Title: Regulation Control Manager Contact E-mail Address: jiang13620586569@126.com Tel: +86-20-82329549 Fax: +86-20-82329549
3. Name of the Device
Device Classification Name: Resin, Root Canal Filling Regulation Description: Root Canal Filling Resin Trade Name: Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-2 ) Regulation Medical Specialty: Dental Review Panel: Dental Product Code: KIF Regulation Number: 21 CFR 872.3820 Device Classification: Class II
4. The Predicate Devices
Predicate device: K212983 Injectable Root Canal Bioceramic Sealer Beijing C-Root Dental Medical Devices Co., LTD.
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5. Device Description
NRSP 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. NRSP is an insoluble, radiopaque and aluminum-free material based on a strontium silicates composition, which requires the presence of water to set and harden. NRSP does not shrink during setting and demonstrates excellent physical properties. NRSP is packaged in a preloaded syringe and is supplied with disposable Intra Canal tips. NRSP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods. NRSP Injectable Root Canal Bioceramic Sealer is available in three preloaded syringe mode that provide different in specification in5g,3g,2g,1g and 0.5g. The only difference between the types are the net weight.
Root canal filling paste is a pre mixed paste material consisting of an inorganic powder system and an organic mixed liquid. It can solidify in a humoral environment, effectively seal the root tip, and has good biocompatibility; The curing time is stable and less affected by root canal moisture and humidity; It has excellent X-ray resistance, fluidity, antibacterial properties, non staining of teeth, and no irritation.
The performance of the Injectable Root Canal Bioceramic Sealer conforms to ISO 6876:2012 Dentistry - Root canal sealing materials.
6. 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.
Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and lateral condensation technique.
7. Summary of Substantial Equivalence
Table 1 Comparison to Predicate Device
| Proposed Device | Predicate device | Comparison | |
|---|---|---|---|
| 510k Number | K212983 | ------ | |
| Product Code | KIF | KIF | Same |
| Regulation No. | 21 CFR 872.3820 | 21 CFR 872.3820 | Same |
| Class | II | II | Same |
| Proprietary Name | InjectableRootCanal BioceramicSealer | InjectableRootCanal BioceramicSealer | ------ |
| Model: | NR SP-0.5, NRSP-1, NR SP-2, NRSP-3, NR SP-5 | C-Root SP | |
| Manufacturer | EnpunoBiotechnology Co.,Ltd | BeijingDentalMedicalDevices Co., LTD. | ------ |
| Indications forUse | Permanentobturation of theroot canalfollowing vitalpulp-extirpation.Permanentobturation of theroot canalfollowing removalof infected ornecrotic pulp andplacement ofintracanaldressings.Injectable RootCanal BioceramicSealer is suitablefor use in the singlecone and lateralcondensationtechnique. | Permanentobturation of theroot canalfollowing vitalpulp-extirpation.Permanentobturation of theroot canalfollowing removalof infected ornecrotic pulp andplacement ofintracanaldressings.Injectable RootCanal BioceramicSealer is suitablefor use in the singlecone and lateralcondensationtechnique. | Same |
| Prescription Use | Yes | Yes | Same |
| Basic ChemicalComposition | Zirconium Oxide,Strontium Silicates,CalciumPhosphates,CalciumHydroxide,Tantalum Oxideand FillerAgents. | Zirconium Oxide,Strontium Silicates,CalciumPhosphates,CalciumHydroxide,Tantalum Oxideand Filler Agents. | Same |
| PerformanceStandardConformance | Conformed to ISO6876 andconformed toTechnicalRequirements of | Conformed to ISO6876 andconformed toTechnicalRequirements of | Same |
| TreatmentSite | "Injectable Root Canal Bioceramic Sealer" addingAppearance,Dimensionalchange followingsetting, pH.Root canalfollowing vitalpulp-extirpation | "Injectable Root Canal Bioceramic Sealer" addingAppearance,Dimensionalchange followingsetting, pH.Root canalfollowing vitalpulp-extirpation | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Biocompatibility | Comply with ISO10993-1:2018,FDAGuidance, testsincludedcytotoxicity,irritation,sensitization, acutesystemictoxicity, subchronicsystemictoxicity test,implantationeffect , endodonticusagetest , Ames test andTK test. | Comply with ISO10993-1:2018,FDAGuidance, testsincludedcytotoxicity,irritation,sensitization, acutesystemictoxicity, subchronicsystemictoxicity test,implantationeffect , endodonticusagetest , Ames test andTK test. | Same |
| Label andLabeling | Conforms to FDARegulatoryRequirements | Conforms to FDARegulatoryRequirements | Same |
| Discussion forSubstantiallyEquivalent (SE) | The proposed device is essentially identical to the predicate devices in terms of indication for use, design between our device and the predicate devices. |
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Enpuno Biotechnology Co., Ltd
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8. Summary of Non-Clinical Testing
Bench testing was performed per ISO 6876:2012 and internal procedures to ensure that the Injectable Root Canal Bioceramic Sealer met its specifications. All tests were verified to meet acceptance criteria. Test results on Appearance, Loading capacity, Flow, Setting time, Film thickness, Dimensional change following setting, Solubility and disintegration, Radio-opacity, PH, Heavy metal content and Microorganism of the
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subject device are very similar to predicate device. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
According to ISO 10993-1:2018, we evaluated and conducted the compatibility test for the proposed device. The following table shows the biocompatibility testing results.
| Item | Proposed device | Result |
|---|---|---|
| In Vitro CytotoxicityTest with L-929 MouseFibroblast Cells MTTCytotoxicity Test (ISO10993-5:2009) | Under the condition of this study , the relative cellviability value of test article Injectable Root CanalBioceramic Sealer is 4.2% which is lower than 70% ,with potential cytotoxicity. | Pass |
| Skin sensitizationtests-Guinea pigmaximization test(GPMT)(ISO 10993-10:2010) | Under the conditions of this test , none of the animalsfrom test and control groups was observed with asensitization response greater than " 1 " during 24h and48h observation time after challenge . The test articleInjectable Root Canal Bioceramic Sealer showed noevidence of causing skin sensitization. | Pass |
| Salmonellatyphimurium reversemutation assay ( Amestest)(ISO 10993-3:2014) | In this test . the test article did not induce substantialincreases in reversion mutation rates of salmonellatyphimurium.Under the conditions of this test . the test articleIniectable Root Canal Bioceramic Sealer is considerednon-mutagenic effect. | Pass |
| Mouse lymphoma cells( TK ) gene mutationtest(ISO 10993-3:2014) | Under the condition of this study , the results of mouselymphoma cell ( TK ) gene mutation test of the testarticle Injectable Root Canal Bioceramic Sealer werenegative , and considered non-mutagenic effect. | Pass |
| Acute SystemicToxicity Test(ISO 10993-11:2017) | Under the conditions of this test , the test articleInjectable Root Canal Bioceramic Sealer didn't lead tothe death of test animals or any signs of toxicity for testanimals , which showed no acute toxicity with a dose of2000mg / kg | Pass |
| Subchronic systemictoxicity Test(ISO 10993-11:2017) | Under the conditions of this study , there was noevidence of subchronic systemic toxicity from the testarticle Injectable Root Canal Bioceramic Sealer. | Pass |
| Bone implant test(ISO 10993-6:2016) | Under the conditions of this experiment , the test articleInjectable Root Canal Bioceramic Sealer ( cured ) hadnew bone formation within the test period ( 4 weeks ,26weeks ) , and the bone tissue reaction ranged from noreaction to slight tissue reaction showing no significantdifference from the control group. | Pass |
| (ISO10993-11:2017) | Injectable Root Canal Bioceramic Sealer showed noevidence of causing pyrogenic reaction | |
| Endodontic usage Test(ISO 7405-2018,MOD) | Histological evaluation : At the time period of 28 days,among the 10 test specimens, 10 specimens showed noinflammation . Among the 5 control specimens , 5specimens showed no inflammation. At the time periodof 90 days, among the 10 test specimens, 10 specimensshowed no inflammation ; among the 5 controlspecimens, 5 specimens showed no inflammation. Nomild, moderate or severe inflammatory reactions wereobserved in the experimental group and control groupduring the long-term and short-term period. X-rayexamination showed no abnormalities. There was nosignificant difference in clinical and histologicalperformance between the test group and the controlgroup.Results and conclusions apply only to the test article .No further evaluation of these results is made by DentalMedical Devices Testing Center of Peking UniversitySchool of Stomatology. Any extrapolation of these datato other samples is the responsibility of the sponsor. Allprocedures were conducted in conformance with DentalMedical Devices Testing Center of Peking UniversitySchool of Stomatology Quality System. | Pass |
Table 2 Biocompatibility testing
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Enpuno Biotechnology Co., Ltd
Note: Testing were Performed on Injectable Root Canal Bioceramic Sealer NR SP-2, (As NR SP-2 is the most widely sold and representative specification in the market), to cover the regular and Injectable Root Canal Bioceramic Sealer.
9. Clinical Test Conclusion
No clinical study is included in this submission.
10. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that subject device Injectable Root Canal Bioceramic Sealer is as safe and effective as the predicate device. Injectable Root Canal Bioceramic Sealer is substantial equivalent to the legally marketed predicate device K212983 Injectable Root Canal Bioceramic Sealer.
§ 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.