510(k) K103194

INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM by Intra-Lock International, Inc. — Product Code DZE

K103194 is an FDA 510(k) premarket notification submitted by Intra-Lock International, Inc. for the device "INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM". The FDA issued a decision of Substantially Equivalent on April 21, 2011. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Intra-Lock International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2011
Date Received
October 29, 2010
Clearance Type
Abbreviated
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