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510(k) K231660

Digital image scanner of dental by Jiangsu Dynamic Medical Technology Co., Ltd. — Product Code MUH

K231660 is an FDA 510(k) premarket notification submitted by Jiangsu Dynamic Medical Technology Co., Ltd. for the device "Digital image scanner of dental". The FDA issued a decision of Substantially Equivalent on December 20, 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
December 20, 2023
Date Received
June 7, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K232325 — RAYSCAN a-Expert (April 18, 2024)
  • K233053 — DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 (November 21, 2023)
  • K232552 — TuxDeluxe (Size 1 6100B, Size 2 6101B) (October 20, 2023)

FDA data resources