Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Quantum Bioengineering, Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130787 | QUANTUM DENTAL IMPLANT SYSTEM | Quantum Bioengineering, Ltd. | 2013-06-13 | 84 | 0 |
| K112279 | QUANTUM DENTAL IMPLANT SYSTEM | Quantum Bioengineering, Ltd. | 2012-05-04 | 269 | 0 |
| K002241 | QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM | Quantum Bioengineering, Ltd. | 2001-09-20 | 423 | 0 |
| K991250 | QUANTUM VERSATILITY IMPLANT SYSTEM | Quantum Bioengineering, Ltd. | 2001-09-20 | 891 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda