510(k) K992161
K992161 is an FDA 510(k) premarket notification submitted by Nordiska Dental AB for the device "CERANA". The FDA issued a decision of Substantially Equivalent on September 22, 1999. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Nordiska Dental AB has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 22, 1999
- Date Received
- June 25, 1999
- 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