The following data is part of a premarket notification filed by Ot Medical Gmbh with the FDA for Naturalline Abutment.
Device ID | K151432 |
510k Number | K151432 |
Device Name: | NaturalLine Abutment |
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 | 2015-05-28 |
Decision Date | 2015-11-05 |