Alpha II

FDA 510(k) K931725 · Dynarad Corp.

Substantially Equivalent

510(k) numberK931725

Submission

Device name
Alpha II
Applicant
Dynarad Corp.
Deer Park, NY, US
Received
April 5, 1993
Decision date
July 14, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EHD – Unit, X-Ray, Extraoral With Timer
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1800
Specialty
Dental

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Questions and answers

When was Alpha II cleared by the FDA?

Alpha II (K931725) received a 510(k) decision of Substantially Equivalent on July 14, 1993, 100 days after the submission was received.

What is the product code of K931725?

The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.