510(k) K030820

EVERSTICK POST by Stick Tech , Ltd. — Product Code ELR

K030820 is an FDA 510(k) premarket notification submitted by Stick Tech , Ltd. for the device "EVERSTICK POST". The FDA issued a decision of Substantially Equivalent on May 20, 2003. The device falls under product code ELR (Post, Root Canal), a Class I device regulated under 21 CFR 872.3810. Stick Tech , Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2003
Date Received
March 14, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Post, Root Canal
Device Class
Class I
Regulation Number
872.3810
Review Panel
DE
Submission Type