The following data is part of a premarket notification filed by Soadco, S.l. with the FDA for Klockner Dental Implant Abutments (ii).
Device ID | K151194 |
510k Number | K151194 |
Device Name: | KLOCKNER DENTAL IMPLANT ABUTMENTS (II) |
Classification | Abutment, Implant, Dental, Endosseous |
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 | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-05-04 |
Decision Date | 2016-01-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08435451602503 | K151194 | 000 |
08435451645005 | K151194 | 000 |
08435451644992 | K151194 | 000 |
08435451644985 | K151194 | 000 |
08435451644978 | K151194 | 000 |
08435451644961 | K151194 | 000 |
08435451644954 | K151194 | 000 |
08435451644886 | K151194 | 000 |
08435451644879 | K151194 | 000 |
08435451644848 | K151194 | 000 |
08435451644305 | K151194 | 000 |
08435451610645 | K151194 | 000 |
08435451610546 | K151194 | 000 |
08435451610508 | K151194 | 000 |
08435451645210 | K151194 | 000 |
08435451659828 | K151194 | 000 |
08435451602091 | K151194 | 000 |
08435451602084 | K151194 | 000 |
08435451602077 | K151194 | 000 |
08435451602060 | K151194 | 000 |
08435451602053 | K151194 | 000 |
08435451602039 | K151194 | 000 |
08435451601865 | K151194 | 000 |
08435451601858 | K151194 | 000 |
08435451601810 | K151194 | 000 |
08435451600684 | K151194 | 000 |
08435451659859 | K151194 | 000 |
08435451659842 | K151194 | 000 |
08435451659835 | K151194 | 000 |
08435451610461 | K151194 | 000 |