(28 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a root canal sealer, with no mention of AI or ML.
Yes.
This device is a root canal sealer used for permanent root canal obturation, which is a therapeutic treatment.
No
This device is a root canal sealer used for permanent root canal obturation, which is a treatment not a diagnostic procedure.
No
The device is a root canal sealer, which is a physical material (a paste/cement) used for obturation. The description focuses on its physical properties and performance testing related to those properties, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Permanent root canal obturation." This is a procedure performed within the body (in the root canal of a tooth) to seal it.
- Device Description: The device is a root canal sealer, a material used to fill and seal the root canal.
- Lack of In Vitro Testing: The description of performance studies focuses on physical properties of the material (setting time, flow, radiopacity, etc.) and biocompatibility testing, which are relevant to a device used in vivo. There is no mention of testing biological samples (blood, urine, tissue, etc.) outside the body to diagnose a condition, which is the hallmark of an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Permanent root canal obturation
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
White ENDOSEAL MTA is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment.
The sealer can be used either alone or in combination with gutta-percha obturating cones, injected gutta-percha material or core-carriers, master cones.
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
Dental professional
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 test articles were tested based on the referenced standard. All the test results met the preset test criteria.
- Testing institution's method Capacity, pH
- ISO 6876 Package, Extraneous matter, Flow, Setting time, Film Thickness, . Solubility, Radio-opacity
- ISO 10993-5 Cytotoxicity (MTT) .
- . ISO 10993-10 - Guinea Pig Maximization Test for Skin sensitization (GPMT)
- ISO 10993-11 Acute systemic toxicity .
- ISO 10993-3 Genotoxicity (Mammalian chromosome aberration test & • Bacterial Reverse Mutation)
Key results from physical properties:
Setting time: 2 hours 27 minutes
Flow: 26.31 mm
Radiopacity: 7.5 mm
Film thickness: 26 μm
Solubility: 0.11 %
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.
Not Found
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
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 includes the text "U.S. Food & Drug Administration" in blue.
August 13, 2021
Maruchi Jang Sung Wook CEO 2-208, Medical Industry Complex Bldg., 42-10, Taejanggongdan-gil Wonju-si, Gangwon-do 26311 South Korea
Re: K212229
Trade/Device Name: White Endoseal MTA Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: July 7, 2021 Received: July 16, 2021
Dear Jang Sung Wook:
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.
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
1
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 (OS) 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, 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
4. INDICATION FOR USE STATEMENT
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name White ENDOSEAL MTA
Indications for Use (Describe) Permanent root canal obturation
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."
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
3
5. 510(k) SUMMARY - K212229
510(k) Summary
Date: July 07, 2021
1. SUBMITTER
MARUCHI
2-208, Medical Industry Complex Bldg., 42-10, Taejanggongdan-gil, Wonju-si, Gangwon-do, 26311, Republic of Korea TEL : +82-33-734-0330 FAX : +82-33-746-2804 Contact Name: Sung Wook, Jang Email: ra@endocem.com
2. DEVICE
·Trade Name: White ENDOSEAL MTA ·Common Name: Root Filling Material · Classification Name: Resin, Root canal filling ·Regulation Number 872.3820 ·Class: 2 ·Classification Product Code: KIF
3. CLEARED DEVICE (PREDICATE DEVICE)
K202015, White ENDOSEAL MTA, MARUCHI
4. DEVICE DESCRIPTION
White ENDOSEAL MTA is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment.
The sealer can be used either alone or in combination with gutta-percha obturating cones, injected gutta-percha material or core-carriers, master cones.
4
5. INDICATIONS FOR USE
Permanent root canal obturation
6. PERFORMANCE TESTING (NON-CLINICAL)
The following test articles were tested based on the referenced standard. All the test results met the preset test criteria.
- Testing institution's method Capacity, pH
- ISO 6876 Package, Extraneous matter, Flow, Setting time, Film Thickness, . Solubility, Radio-opacity
- ISO 10993-5 Cytotoxicity (MTT) .
- . ISO 10993-10 - Guinea Pig Maximization Test for Skin sensitization (GPMT)
- ISO 10993-11 Acute systemic toxicity .
- ISO 10993-3 Genotoxicity (Mammalian chromosome aberration test & • Bacterial Reverse Mutation)
| Modified device | Cleared device (Predicate device) | Discuss/Justify the Differences | |
|---|---|---|---|
| 510(k) Number | New | K202015 | - |
| Trade Name | White ENDOSEAL MTA | White ENDOSEAL MTA | - |
| Manufacturer | MARUCHI | MARUCHI | - |
| Common Name | Root Filling Material | Root Filling Material | Equivalent |
| Classification Name | Resin, Root canal filling | Resin, Root canal filling | Equivalent |
| Device Class | 2 | 2 | Equivalent |
| Product Code | KIF | KIF | Equivalent |
| Device Description | White ENDOSEAL MTA is a root canal sealer conforming to ISO 6876, in a | This product is the root canal sealer conforming to ISO 6876. This is a pre- | Equivalent |
| pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment. The sealer can be used either alone or in combination with gutta-percha obturating cones, injected gutta-percha material or core-carriers, master cones. | loaded syringe type that does not require mixing and is set by absorbing the moisture around the root canal. | ||
| Indications for Use | Permanent root canal obturation | Permanent root canal obturation | Equivalent |
| Intended user | Dental professional | Dental professional | Equivalent |
| Standards | ISO 6876 | ISO 6876 | Equivalent |
| Physical properties | Setting time: 2 hours 27 minutes | ||
| Flow: 26.31 mm | |||
| Radiopacity: 7.5 mm | |||
| Film thickness: 26 μm | |||
| Solubility: 0.11 % | Setting time: 29 min | ||
| Flow: 22 mm | |||
| Radiopacity: 7.7 mm | |||
| Film thickness: 14 μm | |||
| Solubility: 0.3 % | Differences | ||
| Chemical Composition | -Zirconium dioxide | ||
| -Dimethyl sulfoxide | |||
| -Calcium silicate (Tricalcium silicate) | |||
| -Water | |||
| -Bentonite Clay | |||
| -Polyvinyl alcohol | |||
| -Polyvinyl pyrrolidone | |||
| -Lithium Carbonate | -Zirconium dioxide | ||
| -Dimethyl sulfoxide | |||
| -Calcium silicate (Tricalcium silicate) | |||
| -Water | |||
| -Bentonite Clay | |||
| -Polyvinyl alcohol | |||
| -Polyvinyl pyrrolidone | |||
| -Lithium Carbonate | Equivalent | ||
| Liquid Formula | Paste type | Paste type | Equivalent |
| Packaging | Pre-loaded syringe | Pre-loaded syringe | Equivalent |
| Sterile | Non-sterile | Non-sterile | Equivalent |
| Shelf Life | 2 years | 2 years | Equivalent |
7. SUBSTANITAL EQUIVALENCE
5
6
8. SUBSTANTIAL EQUIVALENCE DISCUSSION
The modified device is same to the cleared device in terms of description and indications for use. All of the technical characteristics are substantially equivalent to the corresponding characteristics of the cleared device. There might be slight differences in the weight of raw materials between the modified device and cleared device, however, the chemical composition is same and the data of non-clinical testing such as performance and biological testing provided in this submission proves substantial equivalence to the cleared device in safety and performance.
Therefore, the performance and biocompatibility testing performed demonstrates that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. Hence, it is concluded that it is substantially equivalent to the cleared devices.