510(k) K070772
K070772 is an FDA 510(k) premarket notification submitted by Wieland Dental + Technik GmbH & Co. KG for the device "PRESSX ZR". The FDA issued a decision of Substantially Equivalent on April 30, 2007. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Wieland Dental + Technik GmbH & Co. KG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2007
- Date Received
- March 21, 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