1ST Impression

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K983106 ↗

FDA Product Code

ELW

Device Class

Class II

Regulation

21 CFR Part 872.3660

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. →