MTA ROOT CANAL SEALER

K080203 · Dentsply Interntional · KIF · Mar 26, 2008 · Dental

Device Facts

• Record ID: K080203
• Device Name: MTA ROOT CANAL SEALER
• Applicant: Dentsply Interntional
• Product Code: KIF · Dental
• Decision Date: Mar 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MTA ROOT CANAL SEALER is for the permanent sealing of root canals of teeth and may be used in combination with root canal obturation materials,

Device Story

MTA ROOT CANAL SEALER is a powder and liquid system for endodontic procedures. Mixing the powder and liquid creates a colloidal gel that solidifies to form an impermeable barrier, sealing pathways between the root canal system and external tooth surfaces. Used by dental professionals in a clinical setting to facilitate root canal obturation. The device provides a physical seal to prevent leakage and support tooth restoration.

Clinical Evidence

Bench testing only. Biocompatibility testing for cytotoxicity, mutagenicity, and sensitization was performed to demonstrate safety for endodontic usage.

Technological Characteristics

Powder and liquid system forming a colloidal gel that solidifies into an impermeable barrier. Components are established materials used in legally marketed dental devices. Biocompatibility verified per standard dental device requirements.

Indications for Use

Indicated for permanent sealing of root canals of teeth, used in combination with root canal obturation materials.

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.

Predicate Devices

• MTA Advanced Material (K073218)

Submission Summary (Full Text)

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# MAR 2 6 2008

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

| CONTACT: | Helen Lewis |
|----------------------------|------------------------------------------|
| DATE PREPARED: | January 23, 2008 |
| TRADE OR PROPRIETARY NAME: | MTA ROOT CANAL SEALER |
| CLASSIFICATION NAME: | Root canal filling resin (872.3820, KIF) |
| PREDICATE DEVICES: | MTA Advanced Material K073218 |

DEVICE DESCRIPTION: The MTA ROOT CANAL SEALER is a powder and liquid root canal sealer system. The combination of the powder and liquid creates a colloidal gel that solidifies to form a strong impermeable barrier to seal off pathways of communication between the root canal system and external surfaces of the tooth.

INTENDED USES: MTA ROOT CANAL SEALER is for the permanent sealing of root canals of teeth and may be used in combination with root canal obturation materials,

TECHNOLOGICAL CHARACTERISTICS: All of the components found in MTA ROOT CANAL SEALER have been used in legally marketed devices and/or were found safe for dental use. MTA ROOT CANAL SEALER has been evaluated and passed biocompatibility testing for cytotoxicity, mutagenicity, sensitization and endodontic usage.

SUPPORT OF SUBSTANTIAL EQUIVALENCE: DENTSPLY considers the proposed MTA Root Canal Sealer to be substantially equivalent to the legally marketed MTA Advanced Material (K073218, cleared January 7, 2008). The results of biocompatibility testing have shown that MTA ROOT CANAL SEALER does not raise any new safety/biocompatibility concerns.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2008

Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K080203

Trade/Device Name: MTA ROOT CANAL SEALER Regulation Number: 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: January 23, 2008 Received: January 28, 2008

Dear Ms. Lewis:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Lewis

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Syitte Y. Michain Omd

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE STATEMENT

580 03

510(k) Number (if known):

Device Name: MTA ROOT CANAL SEALER

Indications for Use:

MTA ROOT CANAL SEALER is indicated for use for the permanent sealing of root canals of teeth and may be used in combination with root canal obturation materials.

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (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)

Rkbert mstor Dr. S. Kummer

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

.0(k) Number: KO 80203

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