The following data is part of a premarket notification filed by Soadco, S.l. with the FDA for Klockner Dental Implant Abutments.
Device ID | K122988 |
510k Number | K122988 |
Device Name: | KLOCKNER DENTAL IMPLANT ABUTMENTS |
Classification | Abutment, Implant, Dental, Endosseous |
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 | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-26 |
Decision Date | 2013-07-19 |
Summary: | summary |