FDA applicant
Alpha-Bio Tec, Ltd.
FDA records 4 decisions for Alpha-Bio Tec, Ltd. (Washington, DC) from 2007 to 2026: 4 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and OAT (Implant, Endosseous, Orthodontic). Its devices cite 17 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Alpha Bio Tec , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Alpha-Bio Tec, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2007
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Alpha-Bio Tec, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Alpha-Bio”
FDA records each applicant name separately; these may or may not be the same firm.