The following data is part of a premarket notification filed by Quantum Bioengineering, Ltd. with the FDA for Quantum Dental Implant System.
| Device ID | K130787 |
| 510k Number | K130787 |
| Device Name: | QUANTUM DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | QUANTUM BIOENGINEERING, LTD. 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Contact | Linda Schulz |
| Correspondent | Linda Schulz QUANTUM BIOENGINEERING, LTD. 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-21 |
| Decision Date | 2013-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D825200130014HA0 | K130787 | 000 |
| D825200130011HA0 | K130787 | 000 |
| D825200130009HA0 | K130787 | 000 |
| D825200130008HA0 | K130787 | 000 |