Salivan & Salivan Brown

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K790097 ↗

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 Salivan & Salivan Brown used for?

  Salivan & Salivan Brown is a dental alloy of other noble metal intended for use in dental applications, as indicated by its classification under regulation number 872.3060 and product code EJS, which pertains to dental restorative materials.

• How was Salivan & Salivan Brown cleared for market?

  Salivan & Salivan Brown received FDA 510(k) clearance K790097 through a traditional review process, determined to be substantially equivalent to a predicate device, and was cleared on February 26, 1979, after being received by the FDA on January 16, 1979.

• Who manufactures Salivan & Salivan Brown and where is it produced?

  Salivan & Salivan Brown is manufactured by Den-Mat Corp. in McHenry, Illinois, United States, as specified in the device data with address 803 N. Front St. Suite 3, McHenry, IL 60050.

• What regulatory classification does Salivan & Salivan Brown fall under?

  Salivan & Salivan Brown is classified as a Class II medical device under regulation number 872.3060 with product code EJS, and is categorized under the dental medical specialty, as indicated in the openfda fields and advisory committee designation.