510(k) K801482

HYDRON ROOT CANAL FILLING MATERIAL by National Patent Development Corp. — Product Code KIF

K801482 is an FDA 510(k) premarket notification submitted by National Patent Development Corp. for the device "HYDRON ROOT CANAL FILLING MATERIAL". The FDA issued a decision of Substantially Equivalent on July 21, 1980. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. National Patent Development Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1980
Date Received
May 16, 1980
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