MTA Advanced Material
510(k) K073218
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK073218 | Date7 Jan 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KIF
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3820
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
MTA Advanced Material is a Resin, Root Canal Filling material, classified under FDA Product Code KIF (Dental Devices). It is designed as a biocompatible, hydrophilic material that sets in the presence of moisture, intended for use in endodontic procedures to seal root canal pathways and promote periapical healing. Its formulation supports mineralization and barrier formation within the dental pulp space.
This material is supplied as a single-use, non-sterile product, requiring preparation with water or saline prior to application. It is intended for in-office dental use and must be handled in accordance with standard aseptic techniques. The device carries an FDA 510(k) clearance (K073218) under the Traditional 510(k) Review pathway, with regulatory classification as a Class II device under 21 CFR 872.3820. Storage conditions are not specified but should follow manufacturer guidelines for dental restorative materials.
Other devices from Dentsply International
Questions
AI-generated answers, 19 Sep 2026
What is MTA Advanced Material specifically designed for in dental procedures and how does it differ from traditional root canal filling materials?
MTA Advanced Material is a hydrophilic resin designed for endodontic procedures, specifically to seal root canal pathways and promote periapical healing by supporting mineralization and barrier formation within the dental pulp space. Unlike traditional root canal filling materials, it sets in the presence of moisture, which may offer advantages in maintaining a stable seal in humid environments. It is not intended for general dental restorations but is tailored for controlled use in root canal treatments.
Is MTA Advanced Material pre-sterilized, or does it require preparation before use, and what precautions should be taken?
MTA Advanced Material is supplied as a non-sterile product and must be prepared with water or saline prior to application. Since it is intended for in-office dental use, it should be handled under standard aseptic techniques to ensure sterility at the point of use. The manufacturer’s guidelines for dental restorative materials should be followed for proper storage and preparation.
What are the key differences between the single-use nature of MTA Advanced Material and reusable dental materials?
MTA Advanced Material is explicitly designed as a single-use product, meaning each application requires a new preparation from the original packaging. This contrasts with reusable dental materials, which can be sterilized and reused multiple times. The single-use nature helps ensure consistency in material properties and reduces the risk of cross-contamination between patients, aligning with endodontic best practices for infection control.
How is MTA Advanced Material regulated, and what does its FDA clearance under the Traditional 510(k) pathway mean for clinicians?
MTA Advanced Material holds an FDA 510(k) clearance (K073218) under the Traditional 510(k) Review pathway, classifying it as a Class II device under 21 CFR 872.3820. This means it has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for root canal filling materials. Clinicians can rely on this clearance as evidence of regulatory scrutiny for its intended use in endodontic procedures.