(51 days)
Not Found
No
The summary describes a material (Mineral Trioxide Aggregate) used for dental procedures, with no mention of software, algorithms, or any technology that would incorporate AI/ML.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is used for "Orthograde root canal filling material," "Repair of root perforations," "Repair of root canals as an apical plug," and "Pulp capping," all of which are therapeutic interventions.
No
The device is described as a "root canal filling material" used for repair and filling, indicating it is a therapeutic or restorative material, not a diagnostic tool.
No
The device description clearly states it is a "root canal filling material" and "compositionally formulated to have the physical properties, setting requirements and characteristics necessary for a clinically effective root canal filling material." This indicates a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to dental procedures performed within the patient's body (root canal filling, repair of perforations, apical plug, root end filling, pulp capping). IVDs are used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the material's properties and characteristics as a filling material for root canals, not on analyzing biological samples.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing.
Therefore, Ortho MTA is a medical device used in dental procedures, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Orthograde root canal filling material
- Repair of root perforations during root canal therapy (endodontic therapy), or as a consequence of internal resorption
- Repair of root canals as an apical plug during apexification
- Root end filling
- Pulp capping
Product codes
KIF
Device Description
Ortho MTA (Mineral Trioxide Aggregate) is ideal for orthograde root canal filling. Ortho MTA (Mineral Trioxide Aggregate) is compositionally formulated to have the physical properties, setting requirements and characteristics necessary for a clinically effective root canal filling material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 for DO Medical Co, Ltd. The logo consists of the letters "DO" stacked on top of each other in a stylized font. The words "DO Medical Co, Ltd." are written to the right of the logo. The text is in a simple, sans-serif font.
510(k) Summary
0CT-2 9 2010-
This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 09-02-2010
1. Submission Sponsor
| Submitter | |
|---|---|
| Name | DO Co.,Ltd. |
| Address | 551-1, Yongsan-dong, Yuseong-gu, |
| Daejeon, 305-500, South Korea | |
| Phone | Tel: +82-42-935-8926~9 |
| Fax | Fax: +82-42-936-8927 |
2. Submission Correspondent
LK Consulting Group 2341 W. Crescent Ave. #3, Anaheim, CA 92801 Priscilla Chung Phone: 714-844-2612 Fax: 714-409-3357 Email: agent.fda@gmail.com
3. Device
- · Trade Name: Ortho 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
White MTA Material (K011009), Dentsply International
5. Description:
Ortho MTA (Mineral Trioxide Aggregate) is ideal for orthograde root canal filling. Ortho MTA (Mineral Trioxide Aggregate) is compositionally formulated to have the physical properties, setting requirements and characteristics necessary for a clinically effective root canal filling material.
1
6. Indications for use:
- Orthograde root canal filling material
- · Repair of root perforations during root canal therapy (endodontic therapy), or as a consequence of internal resorption
- · Repair of root canals as an apical plug during apexification
- · Root end filling
- · Pulp capping
7. Safety and Effectiveness:
Ortho MTA(Mineral Trioxide Aggregate) has similar physical and biocompatible properties, and demonstrates comparable performance specifications to White MTA Material(Predicate device). In addition, Ortho MTA (Mineral Trioxide Aggregate) has a comparable delivery system to White 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 Ortho MTA (Mineral Trioxide Aggregate) is safe, effective and substantially equivalent to the predicate device.
8. Conclusion
Based on the information provided in this premarket notification, Ortho MTA (Mineral Trioxide Aggregate) is safe, effective and substantially equivalent to the predicate devices as described herein.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is left-aligned. The text is likely part of a document or sign.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DO Company, Limited C/O Ms. Priscilla Chung LK Consulting Group 2341 West Crescent Avenue, #3 Anaheim, California 92801
UCI 2 9 2010
Re: K102575
Trade/Device Name: Ortho MTA (Mineral Trioxide Aggregate) Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: September 8, 2010 Received: September 8, 2010
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.
ל
3
Page 2 - Ms. Chung
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under 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 Division of Small Manufacturers. International 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
h for
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): | K102575 |
|---|---|
| --------------------------- | --------- |
OCT 2 9 2010
Device Name: Ortho MTA (Mineral Trioxide Aggregate)
Indications For Use:
- Orthograde root canal filling material
- Repair of root perforations during root canal therapy(endodontic therapy), or as a consequence of internal resorption
- · Repair of root canals as an apical plug during apexification
- Root end filling
- · Pulp capping
Prescription Use V (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: | K102575 |