510(k) K800031
K800031 is an FDA 510(k) premarket notification submitted by Espe Dental Products for the device "PERMADYNE POLYETHER RUBBER IMPRESSION". The FDA issued a decision of Substantially Equivalent on February 5, 1980. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Espe Dental Products has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 1980
- Date Received
- January 7, 1980
- 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