510(k) K082158
K082158 is an FDA 510(k) premarket notification submitted by Xpdent Corp for the device "DENSEO FAIRY". The FDA issued a decision of Substantially Equivalent on October 15, 2008. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Xpdent Corp has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2008
- Date Received
- July 31, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powder, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.6660
- Review Panel
- DE
- Submission Type