FDA applicant
Prismatik Dentalcraft, Inc.
FDA records 59 decisions for Prismatik Dentalcraft, Inc. (Irvine, CA) from 2010 to 2026: 59 510(k) clearances. Most are in product codes EIH (Powder, Porcelain) and NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 103 days from receipt to decision, against 129 for FDA’s reviews in the same codes and years. Its devices cite 76 predicates, 33 of them its own earlier devices. 3 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Prismatik Dentalcraft, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Prismatik Dentalcraft, 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) Report