The following data is part of a premarket notification filed by Impladent, Ltd. with the FDA for Laminoss Dental Implant.
Device ID | K933705 |
510k Number | K933705 |
Device Name: | LAMINOSS DENTAL IMPLANT |
Classification | Implant, Endosseous, Root-form |
Applicant | IMPLADENT, LTD. 198-45 FOOTHILL AVE. Holliswood, NY 11423 |
Contact | Maurice Valen |
Correspondent | Maurice Valen IMPLADENT, LTD. 198-45 FOOTHILL AVE. Holliswood, NY 11423 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-30 |
Decision Date | 1996-06-24 |