Skip to content

Agalloy, Disalloy, Epsilon and Lambda

by Fen Dental Mfg., Inc. 510(k)

Active United States

510(k) K942430

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK942430 Date14 Jul 1994ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
EJJ
Device Class
Class II
Regulation
21 CFR Part 872.3070
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Other devices from Fen Dental Mfg., Inc.