510(k) K954133

AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER by American Dental Products, Inc. — Product Code KLE

K954133 is an FDA 510(k) premarket notification submitted by American Dental Products, Inc. for the device "AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER". The FDA issued a decision of Substantially Equivalent on October 30, 1995. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. American Dental Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1995
Date Received
September 1, 1995
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