The following data is part of a premarket notification filed by Ot Medical Gmbh with the FDA for 4plus6line Abutment System.
| Device ID | K151608 |
| 510k Number | K151608 |
| Device Name: | 4plus6Line Abutment System |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | OT MEDICAL GMBH KONSUL-SMIDT-STR. 8B Bremen, DE D-28217 |
| Contact | Martina Behlau |
| Correspondent | Martina Behlau OT MEDICAL GMBH KONSUL-SMIDT-STR. 8B Bremen, DE D-28217 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-15 |
| Decision Date | 2016-04-13 |
| Summary: | summary |