The following data is part of a premarket notification filed by Altatec Biotechnologies N.a., Inc. with the FDA for Screwline.
| Device ID | K022425 | 
| 510k Number | K022425 | 
| Device Name: | SCREWLINE | 
| Classification | Implant, Endosseous, Root-form | 
| Applicant | ALTATEC BIOTECHNOLOGIES N.A., INC. 9229 CRANFORD DR. Potomac, MD 20854 | 
| Contact | Robert J Slomoff | 
| Correspondent | Robert J Slomoff ALTATEC BIOTECHNOLOGIES N.A., INC. 9229 CRANFORD DR. Potomac, MD 20854  | 
| Product Code | DZE | 
| CFR Regulation Number | 872.3640 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Special | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2002-07-24 | 
| Decision Date | 2002-08-14 | 
Mark Image Registration | Serial  | Company  Trademark Application Date  | 
|---|---|
![]() SCREWLINE  76391216  2848373 Live/Registered  | 
        LEYBOLD GMBH  2002-04-03  |