Is this your brand? Sign in to claim ownership.
Sign in to claim this brandPRISMATIK DENTALCRAFT, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 2144 Michelson Drive, Irvine, CA, 92612
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3011649314
- DUNS Number
- —
Catalogue (5582)
Page 111 of 112| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Glidewell IH™ | 70-1206-IMP0009 | FDA UDI | Class II | Active |
| Glidewell IH™ | 70-1074-PRS0085 | FDA UDI | Class II | Active |
| BruxZir™ Basic Shade Coloring Liquid | 70-1123-BRX0010 | FDA UDI | Class II | Active |
| Capture | 70-1030-CAP0003 | FDA UDI | Class II | Active |
| Glidewell IH™ | 70-1073-PRA0093 | FDA UDI | Class II | Active |
| Glidewell HT™ | 70-1190-PRA0067 | FDA UDI | Class II | Active |
| ACE Surgical | 207355 | FDA UDI | Class I | Active |
| BruxZir™ Basic Shade Coloring Liquid | 70-1123-BRX0012 | FDA UDI | Class II | Active |
| Glidewell HT™ | 70-1071-SRG0338 | FDA UDI | Class I | Active |
| Glidewell IH™ | 70-1206-IMP0018 | FDA UDI | Class II | Active |
| Glidewell HT™ | 70-1189-IMP0021 | FDA UDI | Class II | Active |
| ACE Surgical | 207453 | FDA UDI | Class II | Active |
| Glidewell HT™ | 70-1190-PRA0009 | FDA UDI | Class II | Active |
| ACE Surgical | 307606 | FDA UDI | Class I | Active |
| Newport Biologics Resorbable Collagen Plug | 70-BIO-DWD10 | FDA UDI | U | Active |
| Glidewell IH™ | 70-1206-IMP0019 | FDA UDI | Class II | Active |
| Glidewell HT™ | 70-1190-PRS0020 | FDA UDI | Class II | Active |
| Glidewell HT™ | 70-1190-PRC0008 | FDA UDI | Class I | Active |
| ACE Surgical | 2045MU17 | FDA UDI | Class II | Active |
| Glidewell HT™ | 70-1190-PRA0028 | FDA UDI | Class II | Active |
| Glidewell HT™ | 70-1190-IMP0014 | FDA UDI | Class II | Active |
| Glidewell HT™ | 70-1071-SRG0374 | FDA UDI | Class I | Active |
| Glidewell IH™ | 70-1072-PRC0092 | FDA UDI | Class I | Active |
| Glidewell HT™ | 70-1071-SRG0315 | FDA UDI | Class I | Active |
| Glidewell IH™ | 70-1073-PRA0110 | FDA UDI | Class II | Active |
| BruxZir Anterior | K143330 | FDA 510(k) | Class II | Active |
| Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) | K233434 | FDA 510(k) | Class II | Active |
| BruxZir® Esthetic | K240882 | FDA 510(k) | Class II | Active |
| Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System | K151798 | FDA 510(k) | Class II | Active |
| BruxZir™ Incisal Coloring Liquid | K230262 | FDA 510(k) | Class II | Active |
| Inclusive Abutments | K160979 | FDA 510(k) | Class II | Active |
| BruxZir NOW | K220816 | FDA 510(k) | Class II | Active |
| Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems | K252582 | FDA 510(k) | Class II | Active |
| Obsidian® NOW | K234014 | FDA 510(k) | Class II | Active |
| Bruxzir Shaded | K130924 | FDA 510(k) | Class II | Active |
| Inclusive Titanium Abutments Compatible With Straumann Tissue Level Implants | K141211 | FDA 510(k) | Class II | Active |
| BruxZir® Radiant | K240574 | FDA 510(k) | Class II | Active |
| Implant Bar | K120858 | FDA 510(k) | Class II | Active |
| Glidewell™ 3DP Denture Base Resin | K241493 | FDA 510(k) | Class II | Active |
| Silent Nite sl | K183270 | FDA 510(k) | Class II | Active |
| Inclusive Tapered Implant System | K121406 | FDA 510(k) | Class II | Active |
| Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV | K191222 | FDA 510(k) | Class II | Active |
| BruxZir Esthetic | K213425 | FDA 510(k) | Class II | Active |
| Inclusive Titanium Abutments, Compatible With Dentsply Implants Ankylos C/X | K141923 | FDA 510(k) | Class II | Active |
| CAD/CAMouflage Milling Bock | K160425 | FDA 510(k) | Class II | Active |
| Silent Nite Sleep Appliance with the Glidewell Hinge | K210694 | FDA 510(k) | Class II | Active |
| BruxZir GT (Gum Tissue) Color | K191903 | FDA 510(k) | Class II | Active |
| Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems | K240240 | FDA 510(k) | Class II | Active |
| Inclusive Titanium Abutments Compatible With: Straumann Bone Level, Nobel Biocare Branae | K142118 | FDA 510(k) | Class II | Active |
| Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems | K231097 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 30, 2025 | Z-0417-2026 | — | open, classified | Incorrect titanium screw, packaged with dental implant. |
| Apr 14, 2025 | Z-1856-2025 | — | open, classified | Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside. |
| Aug 15, 2016 | Z-2897-2016 | — | terminated | Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. Prismatik failed to properly identify the lots as quarantined product. |