510(k) K760323

X-RAY UNIT, DENTAL DIAGNOSTIC by The S. S. White Co. — Product Code EAP

K760323 is an FDA 510(k) premarket notification submitted by The S. S. White Co. for the device "X-RAY UNIT, DENTAL DIAGNOSTIC". The FDA issued a decision of Substantially Equivalent on August 3, 1976. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. The S. S. White Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1976
Date Received
July 26, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Intraoral
Device Class
Class II
Regulation Number
872.1810
Review Panel
RA
Submission Type