Prismatik Dentalcraft, Inc.
FDA 510(k) & PMA Approved Devices — 35 products
Total Devices35
Categories9
Latest Approval2026-01-30
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K254283 | BruxZir® Shaded 16 PLUS | EIH | 2026-01-30 | View |
| 510(k) | K252582 | Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems | NHA | 2025-11-18 | View |
| 510(k) | K252446 | BruxZir® NOW | EIH | 2025-09-03 | View |
| 510(k) | K250302 | Flexible Partial Resin | EBI | 2025-06-25 | View |
| 510(k) | K242564 | Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit) | KCT | 2025-03-21 | View |
| 510(k) | K250223 | BruxZir® Esthetic NOW | EIH | 2025-02-25 | View |
| 510(k) | K241493 | Glidewell 3DP Denture Base Resin | EBI | 2024-09-12 | View |
| 510(k) | K240240 | Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems | NHA | 2024-07-12 | View |
| 510(k) | K231940 | BruxZir® NOW SRC | NHA | 2024-05-15 | View |
| 510(k) | K240882 | BruxZir® Esthetic | EIH | 2024-05-01 | View |
| 510(k) | K240574 | BruxZir® Radiant | EIH | 2024-03-20 | View |
| 510(k) | K231529 | CloudPoint FastDesign Chairside | PNP | 2024-03-14 | View |
| 510(k) | K234014 | Obsidian® NOW | EIH | 2024-02-27 | View |
| 510(k) | K231097 | Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems | NHA | 2023-11-14 | View |
| 510(k) | K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG) | LRK | 2023-11-14 | View |
| 510(k) | K223496 | Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems | NHA | 2023-09-26 | View |
| 510(k) | K231347 | BruxZir TintEFX Coloring Liquid | EIH | 2023-06-09 | View |
| 510(k) | K230262 | BruxZir Incisal Coloring Liquid | EIH | 2023-05-16 | View |
| 510(k) | K223798 | Glidewell TuffSplint Appliance Resin | MQC | 2023-02-17 | View |
| 510(k) | K220816 | BruxZir NOW | EIH | 2022-08-02 | View |
No matching devices.
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