510(k) K221194
K221194 is an FDA 510(k) premarket notification submitted by Dentmate Technology Co. , Ltd. for the device "LEDEX". The FDA issued a decision of Substantially Equivalent on September 16, 2022. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. Dentmate Technology Co. , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 2022
- Date Received
- April 25, 2022
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Activator, Ultraviolet, For Polymerization
- Device Class
- Class II
- Regulation Number
- 872.6070
- Review Panel
- DE
- Submission Type