510(k) K945714

VERABOND III by Aalba Dent, Inc. — Product Code EJH

K945714 is an FDA 510(k) premarket notification submitted by Aalba Dent, Inc. for the device "VERABOND III". The FDA issued a decision of Substantially Equivalent on December 29, 1994. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Aalba Dent, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1994
Date Received
November 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Metal, Base
Device Class
Class II
Regulation Number
872.3710
Review Panel
DE
Submission Type