The following data is part of a premarket notification filed by Crystal Medical Technology with the FDA for Crystal & Crystal-plus Implants System.
| Device ID | K954432 |
| 510k Number | K954432 |
| Device Name: | CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CRYSTAL MEDICAL TECHNOLOGY 1075 13TH ST. SOUTH, SUITE 231 Birmingham, AL 35294 -4440 |
| Contact | Clint Folsom |
| Correspondent | Clint Folsom CRYSTAL MEDICAL TECHNOLOGY 1075 13TH ST. SOUTH, SUITE 231 Birmingham, AL 35294 -4440 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-25 |
| Decision Date | 1996-07-24 |
| Summary: | summary |