Company · US
Prismatik Dentalcraft, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2026. Name variants (Inc, Corp, punctuation) are merged.
59510(k) clearances (4 in 12 months)
4recalls (1 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EIH | Powder, Porcelain | 22 |
| NHA | Abutment, Implant, Dental, Endosseous | 20 |
| LRK | Device, Anti-Snoring | 5 |
| DZE | Implant, Endosseous, Root-Form | 4 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 4 |
| EBF | Material, Tooth Shade, Resin | 3 |
| MQC | Mouthguard, Prescription | 2 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 |
| NDP | Accessories, Implant, Dental, Endosseous | 1 |
| PNP | Dental Abutment Design Software For Dental Laboratory | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 27, 2026 | K261802 | Glidewell Denture Base Resin Prismatik Dentalcraft, Inc. | EBI |
| Jul 30, 2026 | K262239 | Obsidian® Press Over Zirconia Prismatik Dentalcraft, Inc. | EIH |
| Jan 30, 2026 | K254283 | BruxZir® Shaded 16 PLUS Prismatik Dentalcraft, Inc. | EIH |
| Nov 18, 2025 | K252582 | Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems Prismatik Dentalcraft, Inc. | NHA |
| Sep 3, 2025 | K252446 | BruxZir® NOW Prismatik Dentalcraft, Inc. | EIH |
| Jun 25, 2025 | K250302 | Flexible Partial Resin Prismatik Dentalcraft, Inc. | EBI |
| Mar 21, 2025 | K242564 | Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthe Prismatik Dentalcraft, Inc. | KCT |
| Feb 25, 2025 | K250223 | BruxZir® Esthetic NOW Prismatik Dentalcraft, Inc. | EIH |
| Sep 12, 2024 | K241493 | Glidewell 3DP Denture Base Resin Prismatik Dentalcraft, Inc. | EBI |
| Jul 12, 2024 | K240240 | Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direc Prismatik Dentalcraft, Inc. | NHA |
| May 15, 2024 | K231940 | BruxZir® NOW SRC Prismatik Dentalcraft, Inc. | NHA |
| May 1, 2024 | K240882 | BruxZir® Esthetic Prismatik Dentalcraft, Inc. | EIH |
| Mar 20, 2024 | K240574 | BruxZir® Radiant Prismatik Dentalcraft, Inc. | EIH |
| Mar 14, 2024 | K231529 | CloudPoint FastDesign Chairside Prismatik Dentalcraft, Inc. | PNP |
| Feb 27, 2024 | K234014 | Obsidian® NOW Prismatik Dentalcraft, Inc. | EIH |
| Nov 14, 2023 | K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG) Prismatik Dentalcraft, Inc. | LRK |
| Nov 14, 2023 | K231097 | Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer Prismatik Dentalcraft, Inc. | NHA |
| Sep 26, 2023 | K223496 | Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Prismatik Dentalcraft, Inc. | NHA |
| Jun 9, 2023 | K231347 | BruxZir TintEFX Coloring Liquid Prismatik Dentalcraft, Inc. | EIH |
| May 16, 2023 | K230262 | BruxZir Incisal Coloring Liquid Prismatik Dentalcraft, Inc. | EIH |
| Feb 17, 2023 | K223798 | Glidewell TuffSplint Appliance Resin Prismatik Dentalcraft, Inc. | MQC |
| Aug 2, 2022 | K220816 | BruxZir NOW Prismatik Dentalcraft, Inc. | EIH |
| Jun 29, 2022 | K220960 | BruxZir Opaque Coloring Liquid Prismatik Dentalcraft, Inc. | EIH |
| Jun 22, 2022 | K213765 | Glidewell 3DP Denture Base Resin Prismatik Dentalcraft, Inc. | EBI |
| Feb 23, 2022 | K214102 | Glidewell Appliance Resin, Hard/Soft Prismatik Dentalcraft, Inc. | MQC |
| Nov 17, 2021 | K213425 | BruxZir Esthetic Prismatik Dentalcraft, Inc. | EIH |
| Oct 26, 2021 | K211069 | EndSnorZ Sleep Appliance Prismatik Dentalcraft, Inc. | LRK |
| Jun 16, 2021 | K210694 | Silent Nite Sleep Appliance with the Glidewell Hinge Prismatik Dentalcraft, Inc. | LRK |
| Jun 10, 2020 | K200131 | BruxZir Steel Prismatik Dentalcraft, Inc. | EIH |
| Nov 22, 2019 | K191903 | BruxZir GT (Gum Tissue) Color Prismatik Dentalcraft, Inc. | EIH |
| Aug 5, 2019 | K191222 | Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV Prismatik Dentalcraft, Inc. | NHA |
| Jul 17, 2019 | K183270 | Silent Nite sl Prismatik Dentalcraft, Inc. | LRK |
| Jun 6, 2017 | K170044 | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System Prismatik Dentalcraft, Inc. | NHA |
| Nov 16, 2016 | K162537 | CAD/CAMouflage Milling Block Prismatik Dentalcraft, Inc. | EBF |
| Nov 4, 2016 | K160979 | Inclusive Abutments Prismatik Dentalcraft, Inc. | NHA |
| Jul 15, 2016 | K160425 | CAD/CAMouflage Milling Bock Prismatik Dentalcraft, Inc. | EBF |
| May 23, 2016 | K153099 | INCLUSIVE TAPERED IMPLANT SYSTEM Prismatik Dentalcraft, Inc. | DZE |
| Nov 16, 2015 | K151798 | Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System Prismatik Dentalcraft, Inc. | NHA |
| Oct 7, 2015 | K151375 | Inclusive Titanium Abutments compatible with: Hiossen HG Implant System Prismatik Dentalcraft, Inc. | NHA |
| Oct 1, 2015 | K143515 | Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Impla Prismatik Dentalcraft, Inc. | NHA |
| Jul 2, 2015 | K150872 | BruxZir Anterior Milling Blanks Prismatik Dentalcraft, Inc. | EIH |
| Apr 2, 2015 | K143353 | Hahn Tapered Implant System Prismatik Dentalcraft, Inc. | DZE |
| Jan 6, 2015 | K141923 | INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X Prismatik Dentalcraft, Inc. | NHA |
| Dec 15, 2014 | K143330 | BruxZir Anterior Prismatik Dentalcraft, Inc. | EIH |
| Nov 25, 2014 | K142118 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE Prismatik Dentalcraft, Inc. | NHA |
| Nov 13, 2014 | K142115 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT Prismatik Dentalcraft, Inc. | NHA |
| Nov 6, 2014 | K141887 | OBSIDIAN PRESS (ALL CERAMIC AND POM) Prismatik Dentalcraft, Inc. | EIH |
| Oct 22, 2014 | K141211 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS Prismatik Dentalcraft, Inc. | NHA |
| Aug 20, 2014 | K141788 | OBSIDIAN MILLING BLOCKS Prismatik Dentalcraft, Inc. | EIH |
| Jun 4, 2014 | K133850 | CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE) Prismatik Dentalcraft, Inc. | EBF |
Newest 50 of 59.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2026 | Prismatik Dentalcraft, Inc. Brand Name: Silent Nite
Product Name: Silent Nite Sleep Appliance
Model/Catalog Number: SILNT
Product Description: Silent Nite Sleep Appliance is a mandibular advancement device (MAD) intended to t Open, Classified |
LRK | K183270 K972424 |
| Nov 3, 2025 | Prismatik Dentalcraft, Inc. Brand Name: Inclusive
Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm
Model/Catalog Number: 70-1047-COM0117 Open, Classified |
NHA | K142115 |
| May 28, 2025 | Prismatik Dentalcraft, Inc. Glidewell HT Implant Twist Drill 1.5 x 8 mm " SKU # 70-1071-SRG0266
UDI code: +D7457071SRG02660/$$76254798/16D20250219V
The Glidewell HT" Implant Twist Drill is indicated to prepare the site for plac Open, Classified |
NDP | None listed |
| Aug 15, 2016 | Prismatik Dentalcraft, Inc BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006
The device is indicated for use by dental technicians in the construction of custom made Terminated |
EIH | K130924 |