The following data is part of a premarket notification filed by Basic Dental Implant Systems, Inc. with the FDA for Post And Core - Thin For The Basic Dental Implant System.
Device ID | K022912 |
510k Number | K022912 |
Device Name: | POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | BASIC DENTAL IMPLANT SYSTEMS, INC. 3321 COLUMBIA, N.E. Albuquerque, NM 87107 -2001 |
Contact | Dan Blacklock |
Correspondent | Dan Blacklock BASIC DENTAL IMPLANT SYSTEMS, INC. 3321 COLUMBIA, N.E. Albuquerque, NM 87107 -2001 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-09-03 |
Decision Date | 2002-09-20 |
Summary: | summary |