The following data is part of a premarket notification filed by Hager & Meisinger Gmbh with the FDA for Dental Implant Oktagon Bone Level.
| Device ID | K143539 |
| 510k Number | K143539 |
| Device Name: | Dental Implant OKTAGON Bone Level |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Hager & Meisinger GmbH Hansemannstrasse 10 Neuss, DE 41468 |
| Contact | Wiebke Stolten |
| Correspondent | Wiebke Stolten Hager & Meisinger GmbH Hansemannstrasse 10 Neuss, DE 41468 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-15 |
| Decision Date | 2015-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E0HM50220171 | K143539 | 000 |
| E0HM50220381 | K143539 | 000 |
| E0HM50220391 | K143539 | 000 |
| E0HM50220431 | K143539 | 000 |
| E0HM50220901 | K143539 | 000 |
| E0HM50220911 | K143539 | 000 |
| E0HM50220921 | K143539 | 000 |
| E0HM50220931 | K143539 | 000 |
| E0HM50220941 | K143539 | 000 |
| E0HM50220951 | K143539 | 000 |
| E0HM50220371 | K143539 | 000 |
| E0HM50220361 | K143539 | 000 |
| E0HM50220351 | K143539 | 000 |
| E0HM50220181 | K143539 | 000 |
| E0HM50220191 | K143539 | 000 |
| E0HM50220201 | K143539 | 000 |
| E0HM50220211 | K143539 | 000 |
| E0HM50220221 | K143539 | 000 |
| E0HM50220301 | K143539 | 000 |
| E0HM50220321 | K143539 | 000 |
| E0HM50220331 | K143539 | 000 |
| E0HM50220341 | K143539 | 000 |
| E0HM50221161 | K143539 | 000 |
| E0HM50221171 | K143539 | 000 |
| E0HM503312BL1 | K143539 | 000 |
| E0HM503314BL1 | K143539 | 000 |
| E0HM504108BL1 | K143539 | 000 |
| E0HM504110BL1 | K143539 | 000 |
| E0HM504112BL1 | K143539 | 000 |
| E0HM504114BL1 | K143539 | 000 |
| E0HM504808BL1 | K143539 | 000 |
| E0HM504810BL1 | K143539 | 000 |
| E0HM504812BL1 | K143539 | 000 |
| E0HM503310BL1 | K143539 | 000 |
| E0HM503308BL1 | K143539 | 000 |
| E0HM50221281 | K143539 | 000 |
| E0HM50221181 | K143539 | 000 |
| E0HM50221191 | K143539 | 000 |
| E0HM50221201 | K143539 | 000 |
| E0HM50221221 | K143539 | 000 |
| E0HM50221231 | K143539 | 000 |
| E0HM50221241 | K143539 | 000 |
| E0HM50221251 | K143539 | 000 |
| E0HM50221261 | K143539 | 000 |
| E0HM50221271 | K143539 | 000 |
| E0HM504814BL1 | K143539 | 000 |