510(k) K070956

SEA2 SELF ETCH ADHESIVE by 3M Espe Dental Products — Product Code KLE

K070956 is an FDA 510(k) premarket notification submitted by 3M Espe Dental Products for the device "SEA2 SELF ETCH ADHESIVE". The FDA issued a decision of Substantially Equivalent on May 22, 2007. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. 3M Espe Dental Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2007
Date Received
April 5, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type