510(k) K880392
K880392 is an FDA 510(k) premarket notification submitted by Unitek Corp. for the device "ORTHOLUX VISIBLE LIGHT CURING UNIT". The FDA issued a decision of Substantially Equivalent on April 7, 1988. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. Unitek Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 1988
- Date Received
- January 29, 1988
- 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