510(k) K130140

INTRA-LOCK OP DENTAL IMPLANT by Intra-Lock International — Product Code DZE

K130140 is an FDA 510(k) premarket notification submitted by Intra-Lock International for the device "INTRA-LOCK OP DENTAL IMPLANT". The FDA issued a decision of Substantially Equivalent on August 1, 2013. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Intra-Lock International has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2013
Date Received
January 22, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type