(242 days)
Not Found
No
The summary describes a root-end filling material and its intended uses, focusing on its physical properties and applications in dental procedures. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities. The performance studies focus on bench and biocompatibility testing, not algorithmic performance.
Yes
This device is intended for therapeutic interventions such as root-end filling, repair of root canals, repair of root perforations, and pulp capping, all of which are treatments designed to address and alleviate medical conditions related to dental pulp and root structures.
No
Explanation: This device is a root-end filling and pulp capping material used for therapy and repair, not for diagnosing conditions.
No
The device description clearly indicates a physical material ("root-end filling material," "pulp capping material") used for physical procedures within the body. This is not a software-only device.
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 such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The intended use and device description clearly indicate that this product is a material used within the body for dental procedures (root canal filling, pulp capping, etc.). It is a therapeutic and restorative material, not a diagnostic test performed on a sample outside the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, this device falls under the category of a medical device used for treatment and repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- A root-end filling material
- For the repair of root canals as an apical plug during apexification
- For repair of root perforations during root canal therapy
- As a consequence of internal resorption
- As a pulp capping material
- For the filling of pulpotomy of deciduous tooth
Product codes
KIF
Device Description
This product is designed for vital pulp therapies like direct pulp capping treatment. It effectively prevents secondary infection as well as pulp irritation.
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
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
The following properties were tested for the device according to ISO 6876 and all the results met the test criteria.
- ISO 6876 Setting time, Solubility, Dimensional change following setting and Radiopacity
Key Metrics
Not Found
Predicate Device(s)
MTA MATERIAL (K981620)
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
510(k) Summary
K11207
MAR 1 9 2012
This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 07/15/2011
1. Submission Sponsor
| Submitter | |
|---|---|
| Name | MARUCHI |
| Address | 1720-26 Medical Industry Complex Bldg. No. 2-208, |
| Taejang-dong, Wonju-si, Gangwon-do, 220-120, South | |
| Korea | |
| Phone | |
| Fax | Tel: +82-33-734-0330 |
| Fax: +82-33-746-2804 |
2. Submission Correspondent
LK Consulting Group 951 Starbuck St. Unit J, Fullerton, CA 92833 Priscilla Chung Phone: 714-869-3080 Fax: 714-409-3357 Email: info@LKconsultinggroup.com
3. Device
- · Trade Name: ENDOCEM MTA (Mineral Trioxide Aggregate)
- · Common Name: Root filling material
- · Classification Name: Root canal filling resin
- · Classification regulation: 21 CFR 872.3820
- Product Code: KIF
4. Predicate Device
MTA MATERIAL (K981620), Dentsply International
5. Description:
This product is designed for vital pulp therapies like direct pulp capping treatment. It effectively prevents secondary infection as well as pulp irritation.
510(k) Submission
1
6. Indications for use:
- · A root-end filling material
- · For the repair of root canals as an apical plug during apexification
- · For repair of root perforations during root canal therapy
- · As a consequence of internal resorption
- As a pulp capping material
- · For the filling of pulpotomy of deciduous tooth
7. Safety and Effectiveness:
ENDOCEM MTA (Mineral Trioxide Aggregate) has similar physical and biocompatible properties, and demonstrates comparable performance specifications to MTA MATERIAL (Predicate device). In addition, ENDOCEM MTA (Mineral Trioxide Aggregate) has a comparable delivery system to MTA MATERIAL. 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 ENDOCEM MTA (Mineral Trioxide Aggregate) is safe, effective and substantially equivalent to the predicate device.
8. Physical Characteristics
The following properties were tested for the device according to ISO 6876 and all the results met the test criteria.
- ISO 6876 Setting time, Solubility, Dimensional change following setting and Radiopacity
9. Conclusion
Based on the information provided in this premarket notification, ENDOCEM MTA (Mineral Trioxide Aggregate) is safe, effective and substantially equivalent to the predicate devices as described herein.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three tail feathers, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 9 2012
MARUCHI C/O Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group 951 Starbuck Street, Unit J Fullerton, California 92833
Re: K112078
Trade/Device Name: ENDOCEM MTA (Mineral Trioxide Aggregate) Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: February 22, 2012 Received: February 28, 2012
Dear Ms. Chung:
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. 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.
3
Page 2 - Ms. Chung
Please be advised that FDA's issuance of a substantial equivalence determination does not r reaso be advised a determination that your device complies with other requirements nfour that I Drivial 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing (reporting of incured as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), n you acon bttp://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices prodoc go to might to the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Compilance: "Those pression" (21CFR Part 807.97). For questions regarding the reporting of promarket netification of the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the I ou may obtain other generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours,
Nh fr-
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: ENDOCEM MTA (Mineral Trioxide Aggregate)
Indications for Use:
- · A root-end filling material
- · For the repair of root canals as an apical plug during apexification
- · For repair of root perforations during root canal therapy
- · As a consequence of internal resorption
- As a pulp capping material
- · For the filling of pulpotomy of deciduous tooth
Prescription Use ﺮ (Per 21 CFR 801 Subpart D)
AND
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEE DED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K112078