MTA CEMENTS

K130125 · S&C Polymer Silicon- Und Composite Spezialitaeten · KIF · Jul 24, 2013 · Dental

Device Facts

• Record ID: K130125
• Device Name: MTA CEMENTS
• Applicant: S&C Polymer Silicon- Und Composite Spezialitaeten
• Product Code: KIF · Dental
• Decision Date: Jul 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MTA-B : Repair of root perforations during root canal therapy Root-end filings Pulp capping Repair of root canals as an apical plug during apexification MTA-T : Repair of root perforations during root canal therapy Root-end filings Pulp capping Repair of root canals as an apical plug during apexification MTA-XR: Repair of root perforations during root canal therapy Root-end filings Pulp capping Repair of root canals as an apical plug during apexification MTA-XR Flow: Repair of root perforations during root canal therapy Pulp capping Repair of root canals as an apical plug during apexification

Device Story

MTA Cements (MTA-B, MTA-T, MTA-XR, MTA-XR Flow) are dental materials used by dentists/endodontists for root canal therapy and pulp management. These cements are applied directly to the tooth structure to seal perforations, fill root ends, cap exposed pulp, or create apical plugs. The device functions as a restorative/filling material to provide a seal within the root canal system. It is used in a clinical dental setting. The output is a physical barrier/seal that promotes healing and prevents bacterial ingress, aiding in tooth preservation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mineral Trioxide Aggregate (MTA) based dental cements. Formulated as powder/liquid or flowable variants for endodontic applications. Class II device under 21 CFR 872.3820.

Indications for Use

Indicated for dental patients requiring root perforation repair, root-end filling, pulp capping, or apical plugging during apexification procedures.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

## July 24, 2013

S&C Polymer Silicon-Und Composite Spezialitaeten GmbH Dr. Christian Boettcher Regulatory Compliance Officer Robert-Bosch-Strasse 2 Elmshorn Schleswig-Holstein GERMANY 25335

Re: K130125

Trade/Device Name: MTA Cements Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: June 19, 2013 Received: June 26, 2013

Dear Dr. Boettcher:

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 - Dr. Boettcher

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I hat FDA has made a determination that your device complies with other requirements of the Act that 1 Dr. has Intactions and regulations administered by other Federal agencies. You must or any I edelar banales and store registements, 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 (2) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/8 description: The image shows the text "Mary S. Runner - S" in a bold, sans-serif font. The words "Mary" and "Runner" are in solid black, while the "S." is filled with a pattern of small squares and lines. The "- S" at the end is also in solid black and slightly smaller than the other words.

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Indication for Use

| 510(k) Number (if known): | K130125 |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | MTA Cements |
| Indications for Use: | |
| MTA-B : | <ul><li>Repair of root perforations during root canal therapy</li><li>Root-end filings</li><li>Pulp capping</li><li>Repair of root canals as an apical plug during apexification</li></ul> |
| MTA-T : | <ul><li>Repair of root perforations during root canal therapy</li><li>Root-end filings</li><li>Pulp capping</li><li>Repair of root canals as an apical plug during apexification</li></ul> |
| MTA-XR: | <ul><li>Repair of root perforations during root canal therapy</li><li>Root-end filings</li><li>Pulp capping</li><li>Repair of root canals as an apical plug during apexification</li></ul> |
| MTA-XR Flow: | <ul><li>Repair of root perforations during root canal therapy</li><li>Pulp capping</li><li>Repair of root canals as an apical plug during apexification</li></ul> |
| Prescription Use:<br>(Part 21 CFR 801 Subpart D) | <div> <input checked="true" type="checkbox"/> and / or Over-The-Counter Use: <input type="checkbox"/> (Part 21 CFR 807 Subpart C) </div> |

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Sheena A. Green-S |
|--|------------------------------|
| | 2013.07.24 09:51:31:-04'00' |
| | for M. Susan Runner, DDS, MA |

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

| 510(k) Number: | K130125 |
|----------------|---------|
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