510(k) K992629

D/SENSE II (GREEN-OR) DENTIN DESENSITIZER by Centrix, Inc. — Product Code LBH

K992629 is an FDA 510(k) premarket notification submitted by Centrix, Inc. for the device "D/SENSE II (GREEN-OR) DENTIN DESENSITIZER". The FDA issued a decision of Substantially Equivalent on October 22, 1999. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Centrix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1999
Date Received
July 28, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Varnish, Cavity
Device Class
Class II
Regulation Number
872.3260
Review Panel
DE
Submission Type