510(k) K834559

DELUXE WALL-MOUNTED CEPHALOMETER by Knochen Dental Laboratory — Product Code IWY

K834559 is an FDA 510(k) premarket notification submitted by Knochen Dental Laboratory for the device "DELUXE WALL-MOUNTED CEPHALOMETER". The FDA issued a decision of Substantially Equivalent on February 21, 1984. The device falls under product code IWY (Holder, Head, Radiographic), a Class I device regulated under 21 CFR 892.1920. Knochen Dental Laboratory has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1984
Date Received
December 28, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Head, Radiographic
Device Class
Class I
Regulation Number
892.1920
Review Panel
RA
Submission Type