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 |