Data / Medical devices / United States / Prismatik Dentalcraft, Inc.
Prismatik Dentalcraft, Inc.: FDA-registered device maker in Irvine, CA, United States, 68 510(k) clearances
Prismatik Dentalcraft, Inc. is registered with the FDA (registration 3011649314) in Irvine, CA, United States. It lists 33 device types. The FDA files 68 510(k) clearances under its listings, the newest dated August 27, 2026. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011649314
- Address
- 2144 Michelson Drive, Irvine, CA, United States, 92612
- Owner or operator
- PRISMATIK DENTALCRAFT, INC. (10043585)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 1, 2013
- Registered through
- 2027
- Brand names listed
- 1.5 mm Anchor Sleeve for Inclusive Mini Implant, 17 Degree Multi-Unit Abutment 2 mmH compatible with: Camlog Screw-Line 3.8 mm, 17 Degree Multi-Unit Abutment 2 mmH compatible with: Camlog Screw-Line 4.3 mm, 17 Degree Multi-Unit Abutment 3 mmH compatible with: Camlog Screw-Line 3.8 mm, 17 Degree Multi-Unit Abutment 3 mmH compatible with: Camlog Screw-Line 4.3 mm, 17 Degree Multi-Unit Abutment 5 mmH compatible with: Camlog Screw-Line 4.3 mm, 25 Automix Applicator Tips, 3 mm Abutment for Astra 3 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Articulators | EJP | 1 | Manufacturer | accessdata.fda.gov |
| Barrier, Animal Source, Intraoral | NPL | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Bone Grafting Material, Animal Source | NPM | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Bone Grafting Material, Synthetic | LYC | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Controller, Foot, Handpiece And Cord | EBW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dental Abutment Design Software For Dental Laboratory | PNP | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Device, Anti-Snoring | LRK | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Disk, Abrasive | EHJ | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Surgical Tissue, Dental | EGN | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 27, 2026 | K261802 | Glidewell Denture Base Resin | EBI | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| July 30, 2026 | K262239 | Obsidian® Press Over Zirconia | EIH | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| November 18, 2025 | K252582 | Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| June 25, 2025 | K250302 | Flexible Partial Resin | EBI | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| March 21, 2025 | K242564 | Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit) | KCT | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| February 25, 2025 | K250223 | BruxZir® Esthetic NOW | EIH | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| September 12, 2024 | K241493 | Glidewell 3DP Denture Base Resin | EBI | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| July 12, 2024 | 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 | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| May 15, 2024 | K231940 | BruxZir® NOW SRC | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| May 1, 2024 | K240882 | BruxZir® Esthetic | EIH | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| March 20, 2024 | K240574 | BruxZir® Radiant | EIH | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| March 14, 2024 | K231529 | CloudPoint FastDesign Chairside | PNP | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| February 27, 2024 | K234014 | Obsidian® NOW | EIH | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| November 14, 2023 | K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG) | LRK | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| November 14, 2023 | K231097 | Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| September 26, 2023 | K223496 | Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| June 9, 2023 | K231347 | BruxZir TintEFX Coloring Liquid | EIH | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| May 16, 2023 | K230262 | BruxZir Incisal Coloring Liquid | EIH | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| February 17, 2023 | K223798 | Glidewell TuffSplint Appliance Resin | MQC | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| August 2, 2022 | K220816 | BruxZir NOW | EIH | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| July 6, 2022 | K221033 | UniPrime A, UniPrime E, UniPrime E/C | KLE | Substantially Equivalent | S&C Polymer Silicon- Und Composite Spezialitäten GmbH | accessdata.fda.gov |
| June 29, 2022 | K220960 | BruxZir Opaque Coloring Liquid | EIH | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| June 22, 2022 | K213765 | Glidewell 3DP Denture Base Resin | EBI | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| January 13, 2022 | K203706 | Dental Electric Motor | EBW | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| November 17, 2021 | K213425 | BruxZir Esthetic | EIH | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| October 26, 2021 | K211069 | EndSnorZ Sleep Appliance | LRK | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| February 24, 2021 | K202003 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim | LZA | Substantially Equivalent | Gmp Medicare Sdn. Bhd. | accessdata.fda.gov |
| November 3, 2020 | K201683 | PMMA Block | EBG | Substantially Equivalent | Huge Dental Material Co., Ltd. | accessdata.fda.gov |
| June 10, 2020 | K200131 | BruxZir Steel | EIH | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| November 22, 2019 | K191903 | BruxZir GT (Gum Tissue) Color | EIH | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| August 5, 2019 | K191222 | Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| July 17, 2019 | K183270 | Silent Nite sl | LRK | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| June 6, 2017 | K170044 | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| November 16, 2016 | K162537 | CAD/CAMouflage Milling Block | EBF | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| November 4, 2016 | K160979 | Inclusive Abutments | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| July 15, 2016 | K160425 | CAD/CAMouflage Milling Bock | EBF | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| June 23, 2016 | K152600 | Collagen Dental Wound Dressings | KGN | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| May 23, 2016 | K153099 | INCLUSIVE TAPERED IMPLANT SYSTEM | DZE | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| November 16, 2015 | K151798 | Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| October 7, 2015 | K151375 | Inclusive Titanium Abutments compatible with: Hiossen HG Implant System | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| April 2, 2015 | K143353 | Hahn Tapered Implant System | DZE | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| February 9, 2015 | K141421 | PMMA BLOCK | EBG | Substantially Equivalent | Rizhao Huge Dental Industry Co., Ltd. | accessdata.fda.gov |
| January 6, 2015 | K141923 | INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| November 25, 2014 | K142118 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| November 13, 2014 | K142115 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| November 6, 2014 | K141887 | OBSIDIAN PRESS (ALL CERAMIC AND POM) | EIH | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| November 5, 2014 | K141909 | COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP | NPL | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| October 22, 2014 | K141211 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| August 20, 2014 | K141788 | OBSIDIAN MILLING BLOCKS | EIH | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| May 28, 2014 | K133071 | ELASTIC IMPRESSION MATERIAL | ELW | Substantially Equivalent | Rizhao Huge Dental Industry Co., Ltd. | accessdata.fda.gov |
| March 14, 2014 | K132393 | CERCOM II CEMENT | EMA | Substantially Equivalent | Denali Corporation | accessdata.fda.gov |
| May 16, 2013 | K130924 | BRUXZIR SHADED | EIH | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| February 22, 2013 | K121406 | INCLUSIVE TAPERED IMPLANT SYSTEM | DZE | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| December 10, 2012 | K121391 | INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| December 6, 2012 | K120858 | IMPLANT BAR | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| October 12, 2012 | K121688 | MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| July 29, 2011 | K110600 | COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN | NPL | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| December 28, 2010 | K100993 | INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| December 27, 2010 | K100932 | INCLUSIVE MINI IMPLANT | DZE | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| February 12, 2009 | K083742 | SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX | LYC | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| March 19, 2008 | K080025 | LED.L, LED.M, LED.G, LED.B | EBZ | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| March 15, 2006 | K060104 | PRISMATIK CLINICAL ZIRCONIA | EIH | Substantially Equivalent | Glidewell Laboratories | accessdata.fda.gov |
| March 27, 2003 | K030859 | NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN | EIH | Substantially Equivalent | Enamelite, LLC | accessdata.fda.gov |
| November 1, 2001 | K012767 | S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL | ELW | Substantially Equivalent | S & C Polymer GmbH | accessdata.fda.gov |
| June 11, 2001 | K011431 | RESIN CEM | EMA | Substantially Equivalent | S & C Polymer GmbH | accessdata.fda.gov |
| August 26, 2000 | K000983 | CERAMIX PORCELAIN SYSTEM | EIH | Substantially Equivalent | C-Mix | accessdata.fda.gov |
| September 13, 1995 | K953235 | SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3 | DZE | Substantially Equivalent | The Implant Center of the Palm Beaches | accessdata.fda.gov |
| March 31, 1995 | K951075 | S & C VINYL POLYSILOXANE IMPRESSION MATERIAL | ELW | Substantially Equivalent | S & C Polymer GmbH | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 27, 2026 | 98834 | Class II | Ongoing | 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 treat snoring and mild t | Due to device not having FDA Clearance | accessdata.fda.gov |
| September 30, 2025 | 97720 | Class II | Ongoing | 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 | Incorrect titanium screw, packaged with dental implant. | accessdata.fda.gov |
| April 14, 2025 | 96711 | Class II | Ongoing | 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 placement of endosseous d | Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside. | accessdata.fda.gov |
| August 15, 2016 | 75082 | Class II | Terminated | 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 all ceramic restorati | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Barrier, Animal Source, Intraoral
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Articulators
- All makers of Material, Tooth Shade, Resin
Updated August 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.