FDA applicant
Keystone Dental, Inc.
FDA records 8 decisions for Keystone Dental, Inc. (Burlington, MA) from 2007 to 2024: 8 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 91 days from receipt to decision, against 226 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 3 of them its own earlier devices. 3 recalls are linked to its devices.
FDA’s records also spell it “Keystone Dental”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Keystone Dental, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2018
Class I Class II/III not classified
Planning a device like Keystone Dental, 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 “Keystone”
FDA records each applicant name separately; these may or may not be the same firm.