The following data is part of a premarket notification filed by Medical Biomat with the FDA for Atlantik.
| Device ID | K070794 | 
| 510k Number | K070794 | 
| Device Name: | ATLANTIK | 
| Classification | Filler, Bone Void, Calcium Compound | 
| Applicant | MEDICAL BIOMAT 5, CHEMIN DU CATUPOLAN Vaulx-en-velin, FR 69120 | 
| Contact | Aurelien Bignon | 
| Correspondent | Aurelien Bignon MEDICAL BIOMAT 5, CHEMIN DU CATUPOLAN Vaulx-en-velin, FR 69120 | 
| Product Code | MQV | 
| CFR Regulation Number | 888.3045 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Abbreviated | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2007-03-22 | 
| Decision Date | 2007-07-10 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  ATLANTIK  86172090  not registered Dead/Abandoned | Sons of the Atlantic Limited Liability Company 2014-01-22 | 
|  ATLANTIK  85962446  not registered Dead/Abandoned | Bodegas Fillaboa, S.A. 2013-06-18 | 
|  ATLANTIK  75135503  not registered Dead/Abandoned | Primalco Ltd. 1996-07-17 |