510(k) K914325

ROOT CANAL FILLING CEMENT by Confi-Dental Products Co. — Product Code KIF

K914325 is an FDA 510(k) premarket notification submitted by Confi-Dental Products Co. for the device "ROOT CANAL FILLING CEMENT". The FDA issued a decision of Substantially Equivalent on March 9, 1992. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. Confi-Dental Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1992
Date Received
September 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Root Canal Filling
Device Class
Class II
Regulation Number
872.3820
Review Panel
DE
Submission Type