The following data is part of a premarket notification filed by Soadco, S.l. with the FDA for Klockner Essential Dental Implants System, Models Essential Cone (ec), Essential Solid (es) And Eck.
Device ID | K080224 |
510k Number | K080224 |
Device Name: | KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK |
Classification | Implant, Endosseous, Root-form |
Applicant | SOADCO, S.L. AV FITER I ROSSELL 4 BIS LOCAL 2 Escaldes-engordany, AD Ad-700 |
Contact | Maria Mitjaneta |
Correspondent | Maria Mitjaneta SOADCO, S.L. AV FITER I ROSSELL 4 BIS LOCAL 2 Escaldes-engordany, AD Ad-700 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-01-29 |
Decision Date | 2008-07-03 |
Summary: | summary |