The following data is part of a premarket notification filed by Crystal Medical Technology with the FDA for Crystal And Crystal-seal Implants System.
| Device ID | K980442 |
| 510k Number | K980442 |
| Device Name: | CRYSTAL AND CRYSTAL-SEAL IMPLANTS SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CRYSTAL MEDICAL TECHNOLOGY 181 CAHABA VALLEY PKWY. Pelham, AL 35124 |
| Contact | Clint Folsom |
| Correspondent | Clint Folsom CRYSTAL MEDICAL TECHNOLOGY 181 CAHABA VALLEY PKWY. Pelham, AL 35124 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-04 |
| Decision Date | 1998-03-16 |
| Summary: | summary |