The following data is part of a premarket notification filed by Basic Dental Implant Systems, Inc. with the FDA for Modification To Basic Dental Implant System.
| Device ID | K013682 |
| 510k Number | K013682 |
| Device Name: | MODIFICATION TO 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 | 2001-11-07 |
| Decision Date | 2001-11-28 |
| Summary: | summary |