FDA applicant
Implantech Associates, Inc.
FDA records 41 decisions for Implantech Associates, Inc. (Washington, DC) from 1989 to 2020: 41 510(k) clearances. Most are in product codes FWP (Prosthesis, Chin, Internal) and LZK (Implant, Malar). Its devices cite 11 predicates, 8 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Implantech Associates, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
1in 2013
Class I Class II/III not classified
Planning a device like Implantech Associates, Inc.’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 “Implantech”
FDA records each applicant name separately; these may or may not be the same firm.