510(k) K161855
K161855 is an FDA 510(k) premarket notification submitted by Monitex Industrial Co., Ltd. for the device "LED Curing Light". The FDA issued a decision of Substantially Equivalent on Nov 27, 2017. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. Monitex Industrial Co., Ltd. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 27, 2017
- Date Received
- Jul 6, 2016
- Clearance Type
- Traditional
- 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
- 510(k)