510(k) K203836
K203836 is an FDA 510(k) premarket notification submitted by Changzhou Bomedent Medical Technology Co.,Ltd for the device "BOMEDENT Apex locator, WISMY Apex locator". The FDA issued a decision of Substantially Equivalent on March 30, 2021. The device falls under product code LQY (Locator, Root Apex), a Class U device. Changzhou Bomedent Medical Technology Co.,Ltd has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2021
- Date Received
- December 30, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Locator, Root Apex
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type