510(k) K072933

SPI CONTACT PLATFORM O 4.0 MM by Thommen Medical AG — Product Code DZE

K072933 is an FDA 510(k) premarket notification submitted by Thommen Medical AG for the device "SPI CONTACT PLATFORM O 4.0 MM". The FDA issued a decision of Substantially Equivalent on November 15, 2007. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Thommen Medical AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2007
Date Received
October 16, 2007
Clearance Type
Special
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