510(k) K121093
K121093 is an FDA 510(k) premarket notification submitted by Dxm Co., Ltd. for the device "D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000". The FDA issued a decision of Substantially Equivalent on November 27, 2012. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. Dxm Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 27, 2012
- Date Received
- April 10, 2012
- 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