MINERAL TRIOXIDE AGGREGATE (MTA)

K964174 · Tulsa Dental Products, Ltd. · KIF · Feb 10, 1997 · Dental

Device Facts

• Record ID: K964174
• Device Name: MINERAL TRIOXIDE AGGREGATE (MTA)
• Applicant: Tulsa Dental Products, Ltd.
• Product Code: KIF · Dental
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Mineral Trioxide Aggregate (MTA) is a cement-like substance which seals off all pathways of communication between the root canal system and the external surface of the tooth. Indicated clinical applications include use as repair of pulpal exposures.

Device Story

Mineral Trioxide Aggregate (MTA) is a hydrophilic powder cement; hydrates in presence of moisture to form colloidal gel; solidifies into hard structure. Used by dentists/endodontists in clinical settings to seal root canal pathways and repair pulpal exposures. High sealability; performance unaffected by presence of blood. Applied by hydrating powder to viscous consistency; placed over exposure site; patted into place with moistened cotton ball. Benefits include biocompatibility and superior adaptation to dentinal walls compared to other materials.

Clinical Evidence

Bench testing only. Compressive strength reported at approximately 70 MPa at 21 days. No clinical trial data provided.

Technological Characteristics

Hydrophilic powder cement; sets via hydration in presence of moisture. Forms colloidal gel solidifying to hard structure. Biocompatible. Compressive strength ~70 MPa at 21 days.

Indications for Use

Indicated for repair of pulpal exposures in patients requiring root canal system sealing.

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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K964174

# TULSA DENTAL PRODUCTS
*Shaping The Future of Endodontics™*

## J. Safe Medical Devices Act of 1990 Summary of Safety and Effectiveness:

Submitted by:
Tulsa Dental Products
Russ Vanderslice
5001 East 68th Street, Suite 500
Tulsa, OK 74136
FEB 10 1997

A. Classification Names and Numbers: Dental Cement (other than zinc oxide-eugenol), 76EMA, CFR 872.3275.

B. Common/Usual Names: Dental Cement

C. Proprietary Name: Mineral Trioxide Aggregate (MTA)

D. Establishment Registration Number: 1643003

E. Classification: This device can be classified as a Class II device: Dental Cement (other than zinc oxide-eugenol), 76 EMA, CFR 872.3275.
*Handwritten note: KII 912.3820 P5 1/10/97*

F. Performance Standard: Performance standards have not been established.

G. Description of the Device: Mineral Trioxide Aggregate (MTA) is a cement-like substance which seals off all pathways of communication between the root canal system and the external surface of the tooth. Indicated clinical applications include use as repair of pulpal exposures. The powder consists of fine hydrophilic particles which set in the presence of moisture. Hydration of the powder results in a colloidal gel which solidifies to a hard structure.

Mineral Trioxide Aggregate is biocompatible, and exhibits significantly better adaptation to dentinal walls than other materials. It possesses a high degree of sealability; the presence or absence of blood does not affect its sealing ability. Setting time after hydration and application is approximately three hours. In tests, its compressive strength at 21 days is about 70 Mpa. Use of MTA requires only the appropriate hydration of the powder to a viscous consistency. The mixture can then be placed over the exposure site and gently patted into place using a moistened cotton ball if necessary.

H. Determination of Substantial Equivalence Process: This product has the same intended use as similar products currently cleared for marketing by the 510(k) process for the purpose of repairing pulpal exposures. The technological characteristics for this product are substantially equivalent as those of similar products, used for identical purposes, currently on the market. We believe that sufficiently precise specifications for this material from which this product is constructed have been supplied.

Corporate Headquarters
5001 East 68th Street, Suite 500
Tulsa, OK 74136-3332
1-800-379-3432
[phone]
Fax: [phone]

Manufacturing
3111 Hanover Road
Johnson City, TN 37604
1-800-669-0822
[phone]
Fax: [phone]

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Distribution
3213 Hanover Road
Johnson City, TN 37604
1-800-474-0298
[phone]
Fax: [phone]