510(k) K051797

FUTURE WASH/YPS by 3M Espe AG Dental Products — Product Code ELW

K051797 is an FDA 510(k) premarket notification submitted by 3M Espe AG Dental Products for the device "FUTURE WASH/YPS". The FDA issued a decision of Substantially Equivalent on July 21, 2005. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. 3M Espe AG Dental Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2005
Date Received
July 5, 2005
Clearance Type
Special
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