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Prismatik Dentalcraft, Inc. FDA Approvals
0 new drug approvals and 28 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Glidewell Denture Base Resin510(k)Aug 27, 2026Dental |
| Obsidian® Press Over Zirconia510(k)Jul 30, 2026Dental |
| BruxZir® Shaded 16 PLUS510(k)Jan 30, 2026Dental |
| Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems510(k)Nov 18, 2025Dental |
| BruxZir® NOW510(k)Sep 3, 2025Dental |
| Flexible Partial Resin510(k)Jun 25, 2025Dental |
| Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit)510(k)Mar 21, 2025General Hospital |
| BruxZir® Esthetic NOW510(k)Feb 25, 2025Dental |
| Glidewell 3DP Denture Base Resin510(k)Sep 12, 2024Dental |
| Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems510(k)Jul 12, 2024Dental |
| BruxZir® NOW SRC510(k)May 15, 2024Dental |
| BruxZir® Esthetic510(k)May 1, 2024Dental |
| BruxZir® Radiant510(k)Mar 20, 2024Dental |
| CloudPoint FastDesign Chairside510(k)Mar 14, 2024Dental |
| Obsidian® NOW510(k)Feb 27, 2024Dental |
| Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG)510(k)Nov 14, 2023Dental |
| Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems510(k)Nov 14, 2023Dental |
| Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems510(k)Sep 26, 2023Dental |
| BruxZir TintEFX Coloring Liquid510(k)Jun 9, 2023Dental |
| BruxZir Incisal Coloring Liquid510(k)May 16, 2023Dental |
| Glidewell TuffSplint Appliance Resin510(k)Feb 17, 2023 |
| BruxZir NOW510(k)Aug 2, 2022Dental |
| BruxZir Opaque Coloring Liquid510(k)Jun 29, 2022Dental |
| Glidewell 3DP Denture Base Resin510(k)Jun 22, 2022Dental |
| Glidewell Appliance Resin, Hard/Soft510(k)Feb 23, 2022 |
| BruxZir Esthetic510(k)Nov 17, 2021Dental |
| EndSnorZ Sleep Appliance510(k)Oct 26, 2021Dental |
| Silent Nite Sleep Appliance with the Glidewell Hinge510(k)Jun 16, 2021Dental |