(263 days)
Not Found
No
The description focuses on the material properties and physical characteristics of a root canal sealer, with no mention of AI or ML technologies.
Yes.
The device is intended for the "permanent sealing of root canals" and is used "during endodontic treatment to permanently fill the canal system," which are therapeutic actions.
No
The device is a root canal sealer used for the permanent sealing of root canals, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a mineral trioxide aggregate (MTA) and resin root canal sealer, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "permanent sealing of root canals," which is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a material used to fill the root canal system within the tooth, again, a direct application to the patient.
- Lack of In Vitro Testing for Diagnosis: The document mentions "in vitro cytotoxicity" testing, but this is a biocompatibility test performed on cells in a lab to assess the material's safety, not a diagnostic test performed on patient samples to determine a medical condition.
- No Mention of Analyzing Samples: IVDs are designed to analyze samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis.
Therefore, MTA Fillapex is a medical device used for treatment, not an in vitro diagnostic device used for diagnosis.
N/A
Intended Use / Indications for Use
MTA Fillapex is a root canal sealer intended for the permanent sealing of root canals and may be used in combination with root canal obturation materials.
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
MTA Fillapex is a mineral trioxide aggregate (MTA) and resin root canal sealer used during endodontic treatment to permanently fill the canal system following debridement and disinfection. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. Being hydrophilic in nature, MTA Fillapex is desirable as a root filling material because an isolated dry field is not necessary for use. Moisture does not negatively affect the sealing ability and is required for proper setting. It is used in combination with gutta-percha or silver points during root canal obturation. The device is provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canals
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)
Biocompatibility data were provided to demonstrate substantial equivalence to the predicate devices. Side-by-side cytotoxicity testing (conforming to ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity) was performed that compared the subject device with predicates.
Performance testing that conformed to the protocols and recommended values described in ISO 6876 Dental root canal sealing materials was performed. Test reports included flow, working time, setting time, film thickness, dimensional change, solubility and radiopacity.
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.
K112046, K080203, K820215, K010940, K102163, K893794, K063237
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
K113568
AUG 2 1 2012
510(k) Summary
Angelus Indústria de Produtos Odontológicos S/A
MTA FILLAPEX
August 17. 2012
ADMINISTRATIVE INFORMATION
Manufacturer Name: Angelus Indústria de Produtos Odontológicos S/A Rua Waldir Landgraf, 101 Londrina, PR 86031-218 Brazil Telephone: +55 (43) 2101-3200 Fax: +55 (43) 2101-3201 Official Contact: Marco Canonico International Business Director Representative/Consultant: Allison C. Komiyama Linda K. Schulz PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 USA Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 Email: akomiyama@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Classification Name: Classification Regulation: Product Code: Classification Panel: Reviewing Branch:
MTA Fillapex Root Canal Filling Resin 21 CFR 872-3820, Class II KIF Dental Products Panel Dental Devices Branch
INTENDED USE
MTA Fillapex is a root canal sealer intended for the permanent sealing of root canals and may be used in combination with root canal obturation materials.
1
DEVICE DESCRIPTION
MTA Fillapex is a mineral trioxide aggregate (MTA) and resin root canal sealer used during endodontic treatment to permanently fill the canal system following debridement and disinfection. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. Being hydrophilic in nature, MTA Fillapex is desirable as a root filling material because an isolated dry field is not necessary for use. Moisture does not negatively affect the sealing ability and is required for proper setting. It is used in combination with gutta-percha or silver points during root canal obturation. The device is provided non-sterile.
EQUIVALENCE TO MARKETED DEVICE
K 112046 - Angelus Industria de Produtos Odontologicos S/A, MTA Angelus,
K080203 - Dentsply International, MTA ROOT CANAL SEALER,
-
K820215 Dentsply International, Improved Dycal,
K010940 - Sybron Dental Specialties, Inc.,Sealapex 4, -
K102163 Sybron Dental Specialties, Inc., RealSeal XT Sealer,
-
K893794 Williams Dental Co. Apexit, and
K063237 - Bisco, Inc., TheraCal LC.
The subject device is compositionally substantially equivalent to the predicate devices listed above. The design of the subject device (base/catalyst, two paste system) is similar to the devices cleared in K820215, K010940, K102163, and K893794. The intended use of the subject device is the same as the devices cleared in K112046, K080203, K010940, K102163, and K893794. The subject and predicate devices have the same/similar technological characteristics.
NON-CLINICAL TESTING
Biocompatibility data were provided to demonstrate substantial equivalence to the predicate devices. Side-by-side cytotoxicity testing (conforming to ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity) was performed that compared the subject device with predicates.
Performance testing that conformed to the protocols and recommended values described in ISO 6876 Dental root canal sealing materials was performed. Test reports included flow, working time, setting time, film thickness, dimensional change, solubility and radiopacity.
CONCLUSION
The conclusions drawn from the substantial equivalence discussion as well as non-clinical tests demonstrate that the device is substantially equivalent to the legally marketed devices identified above.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Angelus Indústria de Produtos Odontológicos S/A C/O Ms. Linda K. Schulz PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
AUG 2 1 2012
Re: K113568
Trade/Device Name: MTA - Fillapex Regulation Number: 21 CFR 872.3820 Regulation Name: Root canal filling resin Regulatory Class: II Product Code: KIF Dated: August 13, 2012 Received: August 14, 2012
Dear Ms. Schulz:
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.
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Page 2 - Ms. Schulz
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 (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), 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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ph tor
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
510(k) Premarket Notification
MTA-FILLAPEX
Indications for Use
510(k) Number:
MTA-FILLAPEX Device Name:
Indications for Use:
MTA-FILLAPEX is a root canal sealer intended for the permanent sealing of root canals and may be used in combination with root canal obturation materials.
Susan Ruager
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113568
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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