510(k) K241457

Vista BC Putty by Inter-Med, Inc. — Product Code KIF

K241457 is an FDA 510(k) premarket notification submitted by Inter-Med, Inc. for the device "Vista BC Putty". The FDA issued a decision of Substantially Equivalent on August 28, 2024. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. Inter-Med, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2024
Date Received
May 23, 2024
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