Z-LOOK3 EVO SLM

Implant, Endosseous, Root-form

Z-Systems AG

The following data is part of a premarket notification filed by Z-systems Ag with the FDA for Z-look3 Evo Slm.

Pre-market Notification Details

• Device ID: K120793
• 510k Number: K120793
• Device Name: Z-LOOK3 EVO SLM
• Classification: Implant, Endosseous, Root-form
• Applicant: Z-Systems AG 11234 EL CAMINO REAL STE: 200 San Diego, CA 92024
• Contact: Linda Schulz
• Correspondent: Linda Schulz; Z-Systems AG 11234 EL CAMINO REAL STE: 200 San Diego, CA 92024
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-03-15
• Decision Date: 2012-12-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07640166760153	K120793	000
07640166760009	K120793	000
07640166760016	K120793	000
07640166760023	K120793	000
07640166760030	K120793	000
07640166760047	K120793	000
07640166760054	K120793	000
07640166760061	K120793	000
07640166760078	K120793	000
07640166760085	K120793	000
07640166760092	K120793	000
07640166760108	K120793	000
07640166760115	K120793	000
07640166760122	K120793	000
07640166760139	K120793	000
07640166760146	K120793	000
07640166769491	K120793	000