The following data is part of a premarket notification filed by Ot Medical Gmbh with the FDA for Endosseous Dental Implant.
| Device ID | K113113 |
| 510k Number | K113113 |
| Device Name: | ENDOSSEOUS DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | OT MEDICAL GMBH KONSUL-SMIDT-STR. 8B Bremen, DE D-28217 |
| Contact | Sabine Schmahl |
| Correspondent | Sabine Schmahl OT MEDICAL GMBH KONSUL-SMIDT-STR. 8B Bremen, DE D-28217 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-20 |
| Decision Date | 2012-11-16 |
| Summary: | summary |