510(k) K072569
K072569 is an FDA 510(k) premarket notification submitted by Metoxit AG for the device "METOXIT CAM-BLANKS". The FDA issued a decision of Substantially Equivalent on Oct 31, 2007. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Metoxit AG has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 31, 2007
- Date Received
- Sep 12, 2007
- 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
- 510(k)