(59 days)
No
The device description focuses on the material composition and physical properties of a bioceramic root repair material. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are non-clinical tests related to material properties and biocompatibility.
Yes
The device is a bioceramic root repair material used for permanent root canal repair and filling applications, which are therapeutic interventions.
No
The device is a bioceramic root repair material used for treatment (filling and repair applications), not for diagnosing conditions.
No
The device description clearly states it is a physical material (bioceramic root repair material) packaged in a syringe, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: CeraPutty is a material used within the body (specifically, the root canal) for repair and filling applications. It is a physical material that interacts directly with the patient's tissues.
- Intended Use: The intended uses listed (Repair of Root Perforation, Repair of Root Resorption, Root End Filling, Apexification, Pulp Capping) are all procedures performed directly on the patient's teeth and root canals.
- Device Description: The description details the composition and physical properties of the material itself, not a test or analysis of a biological sample.
Therefore, CeraPutty falls under the category of a medical device used for treatment and repair within the body, not an in vitro diagnostic device used for testing biological samples.
N/A
Intended Use / Indications for Use
- Repair of Root Perforation
- Repair of Root Resorption
- Root End Filling
- Apexification
- Pulp Capping
Product codes
KIF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist
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)
Non-clinical Testing:
- 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)
Key Results:
- Setting time: 44 min
- Solubility: 0.1 %
- Radio-opacity: 4.8
- Biocompatibility: Yes
- Shelf Life: 2 years
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Setting time: 44 min
- Solubility: 0.1 %
- Radio-opacity: 4.8
Predicate Device(s)
Reference Device(s)
Not Found
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.
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.
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"
1
(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
2
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
| 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) |
|---|---|
| ------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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
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
5
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 |
| Classification | ||
| Name | resin, root canal filling | resin, root canal filling |
| Common Name | Root Canal Repair Filling Material | Root Canal Repair Filling Material |
| Product Code | KIF | KIF |
| Regulation | ||
| Number | 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 of
Operation | CeraPutty Bioceramic Root Repair
Material is a convenient ready-to-use
white hydraulic premixed bioceramic
material developed for permanent root
canal repair and surgical applications.
CeraPutty is an insoluble, radiopaque
based on a calcium silicate composition,
which requires the presence of water to set
and harden. CeraPutty Bioceramic Root
Repair Material does not shrink during | iRoot BP Plus Root Repair Material (iRoot
BP Plus) is a convenient ready-to-use white
hydraulic premixed bioceramic paste
developed for permanent root canal repair and
surgical applications. iRoot BP 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. |
6
| | setting and demonstrates excellent
physical properties.
CeraPutty is packaged in a preloaded
container | iRoot BP does not shrink during setting and
demonstrates excellent physical properties.
iRoot BP Plus is packaged in a preloaded
container |
|-------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Standard | 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.