510(k) K061500

SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS by Sic Invent AG — Product Code DZE

K061500 is an FDA 510(k) premarket notification submitted by Sic Invent AG for the device "SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS". The FDA issued a decision of Substantially Equivalent on August 8, 2006. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Sic Invent AG has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2006
Date Received
May 31, 2006
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