CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent root canal repair and filling applications. It is made of Calcium silicate composite, zirconium dioxide which is a radiopaque agent, and a thickening agent. CeraPutty sets and hardens by the moisture inside the oral cavity. CeraPutty does not shrink during setting and demonstrates excellent physical properties. CeraPutty does not require additional mixing for procedures, and its white color which allows aesthetic treatment. Ceraputty is packaged in a preloaded syringe.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "CeraPutty," which is a root canal filling resin. It describes the device, its intended use, and its equivalence to a predicate device. This document is a regulatory filing and does not contain information about a study proving the device meets acceptance criteria in the way a clinical or diagnostic performance study would. It presents information regarding the device's technical characteristics and non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than a study against a specific performance benchmark for diagnostic accuracy or effectiveness with human subjects.

Therefore, many of the requested elements regarding acceptance criteria for a diagnostic device performance study, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, and training set details are not applicable or available in this type of regulatory submission. The document focuses on showing that the new device (CeraPutty) is similar enough to an already approved device (iRoot BP Plus) to be considered safe and effective for the same indications.

Here's the information that can be extracted or inferred from the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in the typical sense of a diagnostic performance study (e.g., minimum sensitivity, specificity). Instead, it compares the performance of the subject device (CeraPutty) to the predicate device (iRoot BP Plus) based on performance standards (ISO 6876) and specific physical properties. The implicit "acceptance criterion" is that the subject device's performance is comparable to or better than the predicate device for these properties, and within the bounds of the standard.

Performance Metric	Acceptance Criteria (implied by predicate, and ISO 6876)	Reported Device Performance (CeraPutty)	Reported Predicate Performance (iRoot BP Plus)
Performance Standard	Conformed to ISO 6876	Conformed to ISO 6876	Conformed to ISO 6876
Setting time	Comparable to predicate; within standard	44 min	5 h 10 min
Solubility	Comparable to predicate; within standard	0.1 %	0.3%
Radio-opacity	Comparable to predicate; within standard	4.8	4.2
Biocompatibility	Yes	Yes	Yes
Shelf Life	2 years	2 years	2 years

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated. The document refers to "Performance tests" and "Biocompatibility Tests" but does not provide details on the number of samples or specimens tested for these non-clinical evaluations.
Data Provenance: Not specified. These are laboratory/bench tests, not clinical data from patients. The manufacturer is Meta Biomed Co., Ltd. in South Korea.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This is not a study requiring expert ground truth in the diagnostic sense. The "ground truth" for the performance tests would be the results obtained from calibrated laboratory equipment according to the specified ISO standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is not a study requiring adjudication of expert interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a material for dental procedures, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a material for dental procedures, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the non-clinical performance tests mentioned (setting time, solubility, radio-opacity) would be derived from measurements obtained via standardized laboratory protocols according to ISO 6876:2012. For biocompatibility, it would be results from standardized biological tests according to ISO 10993 series.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this device.

Summary

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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.

September 29, 2023

Meta Biomed Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620

Re: K232299

Trade/Device Name: CeraPutty Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: August 1, 2023 Received: August 1, 2023

Dear April Lee:

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.

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"

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(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 OS 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).

Sincerely.

Bobak Shirmohammadi -S

For Michael E. Adjodha, M. ChE., CQIA Assistant Director DHT1B: Division of Dental and ENT Devices

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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)	K232299
Device Name	CeraPutty

Indications for Use (Describe)

Repair of Root Perforation
Repair of Root Resorption
Root End Filling
Apexification
Pulp Capping

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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510(k) Summary

Submitter

META BIOMED CO., LTD. Suk Song Oh 270, Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, South Korea Email: ef1459@metabiogw.bizmeka.com Phone: +82-43-230-8841 Fax: +82-43-217-1983

Official Correspondent

Withus Group Inc April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

Device Information

Trade Name: CeraPutty
Classification Name: resin, root canal filling ●
Common Name: Root Canal Repair Filling Material
Product Code: KIF
Panel: Dental
Regulation Number: 21 CFR 872.3820
Device Class: Class II
Date prepared: 09/06/2023

Predicate Devices:

K092715, iRoot BP Plus by Innovative BioCeramix Inc. ●

Device Description

CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent root canal repair and filling applications.

It is made of Calcium silicate composite, zirconium dioxide which is a radiopaque agent, and a thickening agent.

CeraPutty sets and hardens by the moisture inside the oral cavity. CeraPutty does not shrink during setting and demonstrates excellent physical properties.

CeraPutty does not require additional mixing for procedures, and its white color which allows aesthetic treatment.

Ceraputty is packaged in a preloaded syringe.

Indication for Use

Repair of Root Perforation
Repair of Root Resorption ●
Root End Filling
Apexification ●
Pulp Capping

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Non-clinical Testing

The following testing was conducted on our subject device:

Biocompatibility Tests according to ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2016, . ISO 10993-10:2010, ISO 10993-11:2017, and ISO 10993-23:2021
Performance tests such as package and radio-opacity according to ISO 6876:2012 ●
. Shelf Life test: ISO 6876 tests (setting time, Solubility)

Summary of Technological Characteristics:

The subject device and the predicate device have the same intended use and have similar technological characteristics and are made of similar materials. They encompass the same range of physical and chemical properties. The subject device and predicate devices are packaged in similar material and use similar methods of application.

The subject device is different from the predicate devices in raw materials, however, the test results provided in this submission support that it is substantially equivalent to the predicate device.

	Subject Device	Predicate Device
Manufacturer	Meta Biomed Co., Ltd.	Innovative BioCeramix Inc.
Device Name	CeraPutty	iRoot BP Plus
510(k) Number	K232299	K092715
ClassificationName	resin, root canal filling	resin, root canal filling
Common Name	Root Canal Repair Filling Material	Root Canal Repair Filling Material
Product Code	KIF	KIF
RegulationNumber	21 CFR 872.3820	21 CFR 872.3820
Indications for use	- Repair of Root Perforation- Repair of Root Resorption- Root End Filling- Apexification- Pulp Capping	- Repair of Root Perforation- Repair of Root Resorption- Root End Filling- Apexification- Pulp Capping
Raw Material	- Tricalcium silicate- Zirconium dioxide- Dicalcium silicate- Tricalcium aluminate	- Tricalcium silicate- Zirconium oxide- Tantalum pentoxide- Dicalcium silicate- Calcium sulfate
Principle ofOperation	CeraPutty Bioceramic Root RepairMaterial is a convenient ready-to-usewhite hydraulic premixed bioceramicmaterial developed for permanent rootcanal repair and surgical applications.CeraPutty is an insoluble, radiopaquebased on a calcium silicate composition,which requires the presence of water to setand harden. CeraPutty Bioceramic RootRepair Material does not shrink during	iRoot BP Plus Root Repair Material (iRootBP Plus) is a convenient ready-to-use whitehydraulic premixed bioceramic pastedeveloped for permanent root canal repair andsurgical applications. iRoot BP Plus is aninsoluble, radiopaque and aluminum-freematerial based on a calcium silicatecomposition, which requires the presence ofwater to set and harden.

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	setting and demonstrates excellentphysical properties.CeraPutty is packaged in a preloadedcontainer	iRoot BP does not shrink during setting anddemonstrates excellent physical properties.iRoot BP Plus is packaged in a preloadedcontainer
PerformanceStandard	Conformed to ISO 6876	Conformed to ISO 6876
Setting time	44 min	5 h 10 min
Solubility	0.1 %	0.3%
Radio-opacity	4.8	4.2
Biocompatibility	Yes	Yes
Intended Operator	Dentist	Dentist
Sterility	Non-sterile	Non-sterile
Shelf Life	2 years	2 years

Conclusion:

Based on documentation supplied with this submissions drawn from the testing results demonstrate that the subject device is substantially equivalent to our legally marketed predicate device.

Regulation Number and Section

§ 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.