Salivan Paraeight Toughness

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K790096 ↗

FDA Product Code

EJS

Device Class

Class II

Regulation

21 CFR Part 872.3060

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 Salivan Paraeight Toughness device used for?

  The Salivan Paraeight Toughness is an alloy, other noble metal device classified under product code EJS and regulation number 872.3060, intended for dental applications as indicated by its advisory committee classification and device name context within the FDA database.

• How is the Salivan Paraeight Toughness device supplied or manufactured?

  The device is manufactured by Den-Mat Corp. located at 803 N. Front St. Suite 3, Mchenry, Illinois, 60050, United States, and was cleared via the traditional 510(k) pathway under K790096 on February 26, 1979.

• Is the Salivan Paraeight Toughness device reusable or single-use?

  The device data does not specify whether the Salivan Paraeight Toughness is reusable or single-use; therefore, no determination about reusability can be made from the provided information, which focuses on its classification, manufacturer, and regulatory clearance.