The following data is part of a premarket notification filed by Quantum Bioengineering, Ltd. with the FDA for Quantum Versatility Implant System.
| Device ID | K991250 |
| 510k Number | K991250 |
| Device Name: | QUANTUM VERSATILITY IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | QUANTUM BIOENGINEERING, LTD. 201 UNUVERSITY DR., SUITE 101 Plantation, FL 34134 |
| Contact | Raul R Mena |
| Correspondent | Raul R Mena QUANTUM BIOENGINEERING, LTD. 201 UNUVERSITY DR., SUITE 101 Plantation, FL 34134 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-13 |
| Decision Date | 2001-09-20 |
| Summary: | summary |