510(k) K230732

Eagle S/Saevo Slim/D700 Slim by Alliage S/A Industrias Medica Odontológico. — Product Code MUH

K230732 is an FDA 510(k) premarket notification submitted by Alliage S/A Industrias Medica Odontológico. for the device "Eagle S/Saevo Slim/D700 Slim". The FDA issued a decision of Substantially Equivalent on April 11, 2023. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2023
Date Received
March 16, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type