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 |
|---|---|---|
| E0HM221101 | K143539 | 000 |
| E0HM50220231 | K143539 | 000 |
| E0HM50220241 | K143539 | 000 |
| E0HM50220271 | K143539 | 000 |
| E0HM50220281 | K143539 | 000 |
| E0HM50220291 | K143539 | 000 |
| E0HM50221061 | K143539 | 000 |
| E0HM50221071 | K143539 | 000 |
| E0HM50221081 | K143539 | 000 |
| E0HM50221091 | K143539 | 000 |
| E0HM221281 | K143539 | 000 |
| E0HM221271 | K143539 | 000 |
| E0HM221261 | K143539 | 000 |
| E0HM221151 | K143539 | 000 |
| E0HM221161 | K143539 | 000 |
| E0HM221171 | K143539 | 000 |
| E0HM221181 | K143539 | 000 |
| E0HM221191 | K143539 | 000 |
| E0HM221201 | K143539 | 000 |
| E0HM221221 | K143539 | 000 |
| E0HM221241 | K143539 | 000 |
| E0HM221251 | K143539 | 000 |
| E0HM50221101 | K143539 | 000 |
| E0HM50221151 | K143539 | 000 |
| EDRS220131 | K143539 | 000 |
| EDRS220141 | K143539 | 000 |
| EDRS220171 | K143539 | 000 |
| EDRS220181 | K143539 | 000 |
| EDRS220191 | K143539 | 000 |
| EDRS220201 | K143539 | 000 |
| EDRS220211 | K143539 | 000 |
| EDRS220221 | K143539 | 000 |
| EDRS220231 | K143539 | 000 |
| EDRS220121 | K143539 | 000 |
| EDRS220111 | K143539 | 000 |
| EDRS220101 | K143539 | 000 |
| EDRS220011 | K143539 | 000 |
| EDRS220021 | K143539 | 000 |
| EDRS220031 | K143539 | 000 |
| EDRS220041 | K143539 | 000 |
| EDRS220051 | K143539 | 000 |
| EDRS220061 | K143539 | 000 |
| EDRS220071 | K143539 | 000 |
| EDRS220081 | K143539 | 000 |
| EDRS220091 | K143539 | 000 |
| EDRS220241 | K143539 | 000 |
| E0HM221091 | K143539 | 000 |
| E0HM220011 | K143539 | 000 |
| E0HM220141 | K143539 | 000 |
| E0HM220171 | K143539 | 000 |
| E0HM220181 | K143539 | 000 |
| E0HM220191 | K143539 | 000 |
| E0HM220201 | K143539 | 000 |
| E0HM220211 | K143539 | 000 |
| E0HM220221 | K143539 | 000 |
| E0HM220231 | K143539 | 000 |
| E0HM220241 | K143539 | 000 |
| E0HM220131 | K143539 | 000 |
| E0HM220121 | K143539 | 000 |
| E0HM220111 | K143539 | 000 |
| E0HM220021 | K143539 | 000 |
| E0HM220031 | K143539 | 000 |
| E0HM220041 | K143539 | 000 |
| E0HM220051 | K143539 | 000 |
| E0HM220061 | K143539 | 000 |
| E0HM220071 | K143539 | 000 |
| E0HM220081 | K143539 | 000 |
| E0HM220091 | K143539 | 000 |
| E0HM220101 | K143539 | 000 |
| E0HM220271 | K143539 | 000 |
| E0HM220281 | K143539 | 000 |
| E0HM220911 | K143539 | 000 |
| E0HM220921 | K143539 | 000 |
| E0HM220931 | K143539 | 000 |
| E0HM220941 | K143539 | 000 |
| E0HM220951 | K143539 | 000 |
| E0HM220981 | K143539 | 000 |
| E0HM220991 | K143539 | 000 |
| E0HM221061 | K143539 | 000 |
| E0HM221071 | K143539 | 000 |
| E0HM220901 | K143539 | 000 |
| E0HM220431 | K143539 | 000 |
| E0HM220391 | K143539 | 000 |
| E0HM220291 | K143539 | 000 |
| E0HM220301 | K143539 | 000 |
| E0HM220321 | K143539 | 000 |
| E0HM220331 | K143539 | 000 |
| E0HM220341 | K143539 | 000 |
| E0HM220351 | K143539 | 000 |
| E0HM220361 | K143539 | 000 |
| E0HM220371 | K143539 | 000 |
| E0HM220381 | K143539 | 000 |
| E0HM221081 | K143539 | 000 |
| 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 |
| XXXX50221229 | K143539 | 000 |
| EDRS220271 | K143539 | 000 |
| EDRS220901 | K143539 | 000 |
| EDRS220911 | K143539 | 000 |
| EDRS220921 | K143539 | 000 |
| EDRS220931 | K143539 | 000 |
| EDRS220941 | K143539 | 000 |
| EDRS220951 | K143539 | 000 |
| EDRS220981 | K143539 | 000 |
| EDRS220991 | K143539 | 000 |
| EDRS221061 | K143539 | 000 |
| EDRS220431 | K143539 | 000 |
| EDRS220391 | K143539 | 000 |
| EDRS220381 | K143539 | 000 |
| EDRS220281 | K143539 | 000 |
| EDRS220291 | K143539 | 000 |
| EDRS220301 | K143539 | 000 |
| EDRS220321 | K143539 | 000 |
| EDRS220331 | K143539 | 000 |
| EDRS220341 | K143539 | 000 |
| EDRS220351 | K143539 | 000 |
| EDRS220361 | K143539 | 000 |
| EDRS220371 | K143539 | 000 |
| EDRS221071 | K143539 | 000 |
| EDRS221081 | K143539 | 000 |
| EDRS221261 | K143539 | 000 |
| EDRS221271 | K143539 | 000 |
| EDRS221281 | K143539 | 000 |
| XXXX50220399 | K143539 | 000 |
| XXXX50221069 | K143539 | 000 |
| XXXX50221079 | K143539 | 000 |
| XXXX50221089 | K143539 | 000 |
| XXXX50221169 | K143539 | 000 |
| XXXX50221179 | K143539 | 000 |
| EDRS221251 | K143539 | 000 |
| EDRS221241 | K143539 | 000 |
| EDRS221231 | K143539 | 000 |
| EDRS221091 | K143539 | 000 |
| EDRS221101 | K143539 | 000 |
| EDRS221151 | K143539 | 000 |
| EDRS221161 | K143539 | 000 |
| EDRS221171 | K143539 | 000 |
| EDRS221181 | K143539 | 000 |
| EDRS221191 | K143539 | 000 |
| EDRS221201 | K143539 | 000 |
| EDRS221221 | K143539 | 000 |
| XXXX50221199 | K143539 | 000 |