The following data is part of a premarket notification filed by Soadco, S.l. with the FDA for Klockner Dental Implant, Model S3m.
Device ID | K052654 |
510k Number | K052654 |
Device Name: | KLOCKNER DENTAL IMPLANT, MODEL S3M |
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 | 2005-09-26 |
Decision Date | 2006-01-30 |
Summary: | summary |