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.

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.

AI/ML Overview

This document describes the Angelus Indústria de Produtos Odontológicos S/A MTA Fillapex, a root canal sealer. The submission is a 510(k) premarket notification (K113568) and focuses on demonstrating substantial equivalence to previously marketed devices.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test Standard	Acceptance Criteria (from ISO 6876)	Reported Device Performance (MTA Fillapex)	Source in Document
Biocompatibility	ISO 10993-5 (Cytotoxicity)	Not explicitly stated in approval. Implied: demonstrate non-cytotoxicity or equivalence to predicates.	Testing performed demonstrated substantial equivalence to predicate devices (side-by-side cytotoxicity).	{1} Non-Clinical Testing
Physical/Chemical Properties	ISO 6876 (Dental root canal sealing materials)			{1} Non-Clinical Testing
Flow	ISO 6876	(Specific value not provided in document)	Testing performed; results were reported.	{1} Non-Clinical Testing
Working Time	ISO 6876	(Specific value not provided in document)	Testing performed; results were reported.	{1} Non-Clinical Testing
Setting Time	ISO 6876	(Specific value not provided in document)	Testing performed; results were reported.	{1} Non-Clinical Testing
Film Thickness	ISO 6876	(Specific value not provided in document)	Testing performed; results were reported.	{1} Non-Clinical Testing
Dimensional Change	ISO 6876	(Specific value not provided in document)	Testing performed; results were reported.	{1} Non-Clinical Testing
Solubility	ISO 6876	(Specific value not provided in document)	Testing performed; results were reported.	{1} Non-Clinical Testing
Radiopacity	ISO 6876	(Specific value not provided in document)	Testing performed; results were reported.	{1} Non-Clinical Testing

Important Note: The provided document states that "Performance testing that conformed to the protocols and recommended values described in ISO 6876 Dental root canal sealing materials was performed." However, it does not explicitly list the specific acceptance values (e.g., "flow > X mm") for each parameter from ISO 6876, nor does it provide the exact numerical results for MTA Fillapex for each test. It simply states that "Test reports included [list of tests]."

2. Sample Size Used for the Test Set and the Data Provenance

This submission is a 510(k) for a medical device and relies on non-clinical performance testing and biocompatibility data, not a clinical study with a "test set" of patient data.

Sample Size for Non-Clinical Testing: The document does not specify the exact number of samples (e.g., number of specimens for flow testing) used for each non-clinical test. It broadly states that "side-by-side cytotoxicity testing" and "performance testing" were performed.
Data Provenance: The testing was performed by or for the manufacturer, Angelus Indústria de Produtos Odontológicos S/A, based in Brazil. The data is thus considered internal manufacturer data from controlled laboratory settings. It is not retrospective or prospective patient data from a clinical setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This submission does not involve human expert interpretation of clinical data or images to establish a "ground truth." The "ground truth" for non-clinical performance tests is determined by the standardized methods and measurements defined in ISO 6876.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of clinical data requiring expert adjudication. The non-clinical tests follow direct measurement and evaluation against pre-defined ISO standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a traditional medical device (root canal sealer), not an AI/Software as a Medical Device (SaMD). Therefore, no MRMC study, AI assistance, or effect size related to human reader improvement is relevant or discussed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

For the non-clinical performance tests (flow, working time, setting time, etc.), the "ground truth" is defined by the protocols and recommended values described in the international standard ISO 6876 Dental root canal sealing materials. For biocompatibility, the ground truth is established by the methods outlined in ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for physical medical devices of this type. Performance is demonstrated through direct testing against established material science standards.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set."

Summary

{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

lschulz@paxmed.com

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

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.

{2}------------------------------------------------

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.

{3}------------------------------------------------

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

K113568

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)

Page 1 of

Regulation Number and Section

§ 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.