MTA MATERIAL II

K981620 · Dentsply Intl. · KIF · Jul 31, 1998 · Dental

Device Facts

• Record ID: K981620
• Device Name: MTA MATERIAL II
• Applicant: Dentsply Intl.
• Product Code: KIF · Dental
• Decision Date: Jul 31, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MTA MATERIAL is indicated for use as a root end filling material.

Device Story

MTA Material consists of fine hydrophilic powder particles. Upon hydration, the powder forms a colloidal gel that solidifies into a hard structure. Used by dental professionals as a root end filling material. The device is applied to the root end to seal the canal. The material's hardening properties provide a physical barrier, aiding in the sealing of the root canal system, which supports healing and prevents leakage.

Clinical Evidence

No new clinical data provided. Substantial equivalence is based on the identical formulation to predicate devices and previously submitted in-vitro and animal study performance data.

Technological Characteristics

Fine hydrophilic powder; hydrates to form a colloidal gel that hardens. Identical to predicates K964174 and K980332.

Indications for Use

Indicated for use as a root end filling material in patients requiring endodontic treatment.

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

• Mineral Trioxide Aggregate (K964174)
• MTA Material (K980332)

Submission Summary (Full Text)

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JUL 31 1998

K981620

### 510(k) SUMMARY

DENTSPLY

#### NAME & ADDRESS:

#### DENTSPLY International

570 West College Avenue P.O. Box 872 York, PA 17405-0872 [phone] Fax [phone]

P. J. Lehn Telefax [phone]

CONTACT: P. Jeffery Lehn

DATE PREPARED: MAY 8 ,1998

TRADE OR PROPRIETARY NAME: MTA MATERIAL

Root Filling Material COMMON OR USUAL NAME:

872.3820 Root canal filling resin material CLASSIFICATION NAME: K964174 PREDICATE DEVICE: Mineral Trioxide Aggregate K980332 MTA Material

DEVICE DESCRIPTION: MTA MATERIAL is identical to K964174 and K980332. This submission is for a new intended use.

MTA MATERIAL is a powder consisting of fine hydrophilic particles. Hydration of the powder results in a colloidal gel, which solidifies to a hard structure.

INTENDED USE: MTA MATERIAL is indicated for use as a root end filling material.

TECHNOLOGICAL CHARACTERISTICS: MTA MATERIAL is identical to DENTSPLY'S K964174 and K980332. This submission is for an additional intended use.

The fact that the formula is identical to K964174 and K980332 leads to the conclusion that biocompatibility studies with the formulation are not necessary

Therefore, we believe that the prior use of the formula in K964174 and K980332, the in-vitro and animal study performance data provided, and the results of previous testing in K964174 support the safety and effectiveness of MTA MATERIAL for the new intended use.

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### Substantial Equivalence Comparison:

#### ID of Predicate Device:

K964174 and K980332 are the predicate devices for this submission. MTA MATERIAL is identical to the predicates. This submission is for a new intended use only.

### Statement of Similarities and/or Differences:

MTA MATERIAL is identical to K964174 and K980332. This submission is for a new intended use only.

- This submission addresses the new intended use: Root end filling material. ●
- K980332 addresses the uses: Repair of root canals as an apical plug during Apexification, . and repair of Root Perforations during root canal therapy (endodontic therapy) or as a consequence of internal resorption.
- K964174 addresses the use: Intended to be applied to a tooth to protect the pulp. ●

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure in black, with its wings forming a curved shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird. The text is in all capital letters and is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 | 1998

Mr. P. Jeffrey Lehn ·Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872

Re : K981620 MTA Material II Trade Name: Requlatory Class: İI Product Code: KIF Dated: May 5, 1998 May 6, 1998 Received:

Dear Mr. Lehn:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Lehn

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

: 中

Sincerely yours,

S. Dutrow for

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## PREMARKET NOTIFICATION

# INDICATIONS FOR USE STATEMENT

510(K) Number:

:

Device Name:

MTA MATERIAL II

MTA MATERIAL II is indicated for use as a root end filling material.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Skinner

(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Devices 510(k) Number J K98 160

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