The following data is part of a premarket notification filed by Soadco, S.l. with the FDA for Klockner Essential Dental Implants System, Model Essential Cone 1.5.
| Device ID | K082200 |
| 510k Number | K082200 |
| Device Name: | KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5 |
| 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 | 2008-08-04 |
| Decision Date | 2008-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08435451604637 | K082200 | 000 |
| 08435451633941 | K082200 | 000 |
| 08435451633934 | K082200 | 000 |
| 08435451633927 | K082200 | 000 |
| 08435451633880 | K082200 | 000 |
| 08435451633873 | K082200 | 000 |
| 08435451633866 | K082200 | 000 |
| 08435451633859 | K082200 | 000 |
| 08435451633811 | K082200 | 000 |
| 08435451633804 | K082200 | 000 |
| 08435451633798 | K082200 | 000 |
| 08435451633774 | K082200 | 000 |
| 08435451633767 | K082200 | 000 |
| 08435451633750 | K082200 | 000 |
| 08435451635259 | K082200 | 000 |
| 08435451604460 | K082200 | 000 |
| 08435451604477 | K082200 | 000 |
| 08435451604620 | K082200 | 000 |
| 08435451604613 | K082200 | 000 |
| 08435451604606 | K082200 | 000 |
| 08435451604590 | K082200 | 000 |
| 08435451604583 | K082200 | 000 |
| 08435451604576 | K082200 | 000 |
| 08435451604569 | K082200 | 000 |
| 08435451604545 | K082200 | 000 |
| 08435451604538 | K082200 | 000 |
| 08435451604521 | K082200 | 000 |
| 08435451604514 | K082200 | 000 |
| 08435451604491 | K082200 | 000 |
| 08435451604484 | K082200 | 000 |
| 08435451633743 | K082200 | 000 |