The following data is part of a premarket notification filed by Soadco, S.l. with the FDA for Klockner Vega Dental Implant System.
Device ID | K153098 |
510k Number | K153098 |
Device Name: | KLOCKNER VEGA DENTAL IMPLANT SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | SOADCO, S.L. AVGDA. FITER I ROSELL., 4 BIS-LOCAL 2 Escaldes-engordany, AD Ad-700 |
Contact | Maria Mitjaneta |
Correspondent | Maria Mitjaneta SOADCO, S.L. AVGDA. FITER I ROSELL., 4 BIS-LOCAL 2 Escaldes-engordany, AD Ad-700 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-10-26 |
Decision Date | 2016-04-08 |