510(k) K251880

Archy Dental Imaging by Archy Dental, Inc. — Product Code LLZ

K251880 is an FDA 510(k) premarket notification submitted by Archy Dental, Inc. for the device "Archy Dental Imaging". The FDA issued a decision of Substantially Equivalent on Nov 21, 2025. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 21, 2025
Date Received
Jun 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type