510(k) K000591
K000591 is an FDA 510(k) premarket notification submitted by Espe Dental AG for the device "DIMENSION PENTA H, DIMENSION PENTA H QUICK". The FDA issued a decision of Substantially Equivalent on March 30, 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
- March 30, 2000
- Date Received
- February 22, 2000
- 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