Teethmate-F
by Kuraray Co. 510(k)
Active
510(k) K910424
Overview
Teethmate-F is a dental cement, classified as a Class II medical device under FDA regulations. It is designed to bond dental restorations, such as crowns, bridges, and inlays, to tooth structures, ensuring mechanical retention and chemical adhesion for long-term stability in restorative dentistry.
This product is supplied as a single-use, non-sterile kit requiring mixing prior to application. It is intended for use in clinical dental settings and must be handled in accordance with standard dental practice guidelines. The device is authorized under FDA 510(k) clearance (K910424) and adheres to regulatory standards outlined in 21 CFR 872.3275. No MRI safety information or reusable specifications are provided.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK910424 | Date3 Apr 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- EMA
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3275
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Kuraray Co.
Questions
Is Teethmate-F intended for use in permanent dental restorations like crowns and bridges, or is it also suitable for temporary fixes?
Teethmate-F is specifically designed for bonding dental restorations such as crowns, bridges, and inlays to tooth structures, ensuring long-term stability. The description does not mention temporary use, so it is intended for permanent restorative applications in clinical dental settings.
How is Teethmate-F supplied, and does it require any special handling before use?
Teethmate-F is supplied as a single-use, non-sterile kit that requires mixing prior to application. Since it is non-sterile, it must be handled in accordance with standard dental practice guidelines to ensure proper use and sterility of the prepared restoration site.
Can Teethmate-F be reused, or is it designed for one-time application per patient?
Teethmate-F is explicitly described as a single-use product, meaning each kit is intended for one application per patient. Reuse is not supported or recommended based on the provided data.
What regulatory pathway was followed for FDA clearance of Teethmate-F, and what does this mean for its use in clinical settings?
Teethmate-F received FDA clearance through a 510(k) submission (K910424) under the Traditional clearance type, classified as a Class II medical device. This means it was determined to be substantially equivalent to a legally marketed predicate device and adheres to regulatory standards outlined in 21 CFR 872.3275. Clinicians may rely on this clearance as evidence of safety and effectiveness for bonding dental restorations as described.
Are there any specific storage instructions for Teethmate-F, or should it be kept under particular conditions before use?
The provided data does not specify storage conditions for Teethmate-F, but since it is non-sterile and intended for single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines (Kuraray Co.) for optimal shelf life and handling.