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Cs 1200

by Carestream Health, Inc.

510(k) K112321

Cs 1200 is a Class I device made by Carestream Health, Inc., cleared under FDA 510(k) K112321 on 10 Nov 2011, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK112321 Date10 Nov 2011ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
EIA
Device class
Class I
Regulation
21 CFR Part 872.6640
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Devices cleared under K112321

3 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K112321
UDI-DISize and differences
CS 1200
Carestream Dental LLC
6559991 / CS 120060192156559999 —On the market
CS 1200
Carestream Dental LLC
6560072 / CS 120060192156560070 —On the market
CS 1200
Carestream Dental LLC
9G5275 / CS 120060192155950438 —On the market

Similar devices

Other devices filed under FDA product code EIA (Unit, Operative Dental).

Other devices from Carestream Health, Inc.

See all devices from Carestream Health, Inc. →