510(k) K994190
K994190 is an FDA 510(k) premarket notification submitted by Espe Dental AG for the device "IMPREGUM GARANT L DUOSOFT". The FDA issued a decision of Substantially Equivalent on January 27, 2000. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Espe Dental AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 2000
- Date Received
- December 13, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type