The following data is part of a premarket notification filed by Quantum Bioengineering, Ltd. with the FDA for Quantum Versatility (qvs) Dental Implant System.
| Device ID | K002241 |
| 510k Number | K002241 |
| Device Name: | QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | QUANTUM BIOENGINEERING, LTD. 201 UNUVERSITY DR., SUITE 101 Plantation, FL 34134 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson 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 | 2000-07-24 |
| Decision Date | 2001-09-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D825200150014HA0 | K002241 | 000 |
| D825200150011HA0 | K002241 | 000 |
| D825200150009HA0 | K002241 | 000 |
| D825200140014HA0 | K002241 | 000 |
| D825200140011HA0 | K002241 | 000 |
| D825200140009HA0 | K002241 | 000 |
| D825200135014HA0 | K002241 | 000 |
| D825200135011HA0 | K002241 | 000 |
| D825200135009HA0 | K002241 | 000 |