510(k) K173207

SIC invent Dental Implant Systems by Sic Invent AG — Product Code DZE

K173207 is an FDA 510(k) premarket notification submitted by Sic Invent AG for the device "SIC invent Dental Implant Systems". The FDA issued a decision of Substantially Equivalent on April 5, 2018. 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
April 5, 2018
Date Received
October 2, 2017
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