Portable Hdx Intraoral X-Ray

• • Terminated Z-1272-02 FDA Unclassified (pre-2012) ·initiated 16 May 2003 ·on shared 510(k) K021378

  problems with product label

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K021378 ↗

FDA Product Code

EHD

Device Class

Class II

Regulation

21 CFR Part 872.1800

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  Class I

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