FDA applicant
Syntex Dental Products, Inc.
FDA records 3 decisions for Syntex Dental Products, Inc. (Mchenry, IL) from 1982 to 1983: 3 510(k) clearances. Most are in product codes EKQ (Preparer, Root Canal Endodontic) and EIA (Unit, Operative Dental). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Syntex Dental Products, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Syntex Dental Products, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Syntex Dental Products, 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 “Syntex”
FDA records each applicant name separately; these may or may not be the same firm.