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Kodak Models 2100 and 2200

by Kodak-Trophy 510(k)

Active United States

510(k) K060292

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK060292 Date3 Mar 2006ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1128-2014 FDA Class II initiated 24 Jan 2014
    • Terminated Z-1127-2014 FDA Class II initiated 24 Jan 2014

    Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.

Specification

510(k)

510(k) Number
FDA Product Code
EHD
Device Class
Class II
Regulation
21 CFR Part 872.1800
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent