Den-Mat Tenure

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K872510 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Gingitract

  Class I

  FDA 510(k) K771973 Active Cleared 7 Nov 1977

• Kwikap

  Class I

  FDA 510(k) K772315 Active Cleared 3 Jan 1978

• Den-Mat Dentin Link

  Class II

  FDA 510(k) K862449 Active Cleared 22 Jul 1986

• Den-Mat Polishing Paste

  Class I

  FDA 510(k) K801225 Active Cleared 17 Jun 1980

• Den-Mat 4-Minute Denture Cleaner

  Class I

  FDA 510(k) K791925 Active Cleared 26 Oct 1979

• Den-Mat Cerinate Porcelain

  Class II

  FDA 510(k) K895731 Active Cleared 3 Aug 1990

See all devices from Den-Mat Corp. →

• What is the primary purpose or intended use of the DEN-MAT TENURE device in clinical settings?

  The DEN-MAT TENURE is a dental device classified under product code EBF, which is reviewed by the Dental Advisory Committee. While the exact clinical indication isn’t detailed in the data, its classification suggests it is likely used in dental restorative or orthodontic procedures, such as securing temporary crowns, bridges, or orthodontic appliances. The FDA clearance under 510(k) confirms it is intended for dental applications, though the precise use would depend on standard practices for devices in this category.

• How is the DEN-MAT TENURE supplied, and is it single-use or reusable?

  The provided data does not specify supply details like packaging, sterilization method, or whether the device is single-use or reusable. Dental devices in this category (product code EBF) often include temporary restorative materials or orthodontic attachments, which are typically single-use or require sterilization if reusable. For accurate supply information, refer to the manufacturer’s instructions or packaging.

• What regulatory pathway was followed for FDA clearance of the DEN-MAT TENURE, and when was it approved?

  The DEN-MAT TENURE received FDA 510(k) clearance through a traditional review process and was determined to be substantially equivalent to a predicate device. The application was submitted on June 24, 1987, and clearance was granted on August 24, 1987, with the K-number K872510. This classification confirms it was reviewed for safety and effectiveness under the 510(k) program before market availability.

• Is there any information about storage requirements or shelf life for the DEN-MAT TENURE?

  The data does not include details on storage conditions, shelf life, or expiration dates for the DEN-MAT TENURE. Dental devices like this often require protection from moisture, extreme temperatures, or contamination. For proper storage instructions, consult the manufacturer’s labeling or accompanying documentation, as these are critical for maintaining device integrity and performance.