510(k) K052593
K052593 is an FDA 510(k) premarket notification submitted by Dentlight, Inc. for the device "FUSION CURING LIGHT". The FDA issued a decision of Substantially Equivalent on September 28, 2005. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. Dentlight, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 2005
- Date Received
- September 21, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Activator, Ultraviolet, For Polymerization
- Device Class
- Class II
- Regulation Number
- 872.6070
- Review Panel
- DE
- Submission Type