510(k) K050970

MILO DENTAL IMPLANT SYSTEM by Intra-Lock International — Product Code DZE

K050970 is an FDA 510(k) premarket notification submitted by Intra-Lock International for the device "MILO DENTAL IMPLANT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 14, 2005. 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
October 14, 2005
Date Received
April 18, 2005
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