510(k) K060684

ADPER PROMPT, ADPER PROMPT L-POP by 3M Espe AG Dental Products — Product Code KLE

K060684 is an FDA 510(k) premarket notification submitted by 3M Espe AG Dental Products for the device "ADPER PROMPT, ADPER PROMPT L-POP". The FDA issued a decision of Substantially Equivalent on April 24, 2006. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. 3M Espe AG Dental Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2006
Date Received
March 15, 2006
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