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 |