Prismatik Dentalcraft, Inc.
Irvine, CA, US
PRISMATIK DENTALCRAFT, INC. appears in FDA device records in Irvine, CA. FDA records list 58 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 58FDA records hold 58 510(k) clearances for Prismatik Dentalcraft, Inc. between 2010 and 2026. The busiest year on record is 2014, with 7. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 3 |
| 2012 | 3 |
| 2013 | 3 |
| 2014 | 7 |
| 2015 | 6 |
| 2016 | 4 |
| 2017 | 1 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 4 |
| 2023 | 6 |
| 2024 | 7 |
| 2025 | 5 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262239 | Obsidian® Press Over Zirconia | EIH | Substantially Equivalent | |
| K254283 | BruxZir® Shaded 16 PLUS | EIH | Substantially Equivalent | |
| K252582 | Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems | NHA | Substantially Equivalent | |
| K252446 | BruxZir® NOW | EIH | Substantially Equivalent | |
| K250302 | Flexible Partial Resin | EBI | Substantially Equivalent | |
| K242564 | Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) | KCT | Substantially Equivalent | |
| K250223 | BruxZir® Esthetic NOW | EIH | Substantially Equivalent | |
| K241493 | Glidewell™ 3DP Denture Base Resin | EBI | Substantially Equivalent | |
| 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 | |
| K231940 | BruxZir® NOW SRC | NHA | Substantially Equivalent | |
| K240882 | BruxZir® Esthetic | EIH | Substantially Equivalent | |
| K240574 | BruxZir® Radiant | EIH | Substantially Equivalent | |
| K231529 | CloudPoint FastDesign Chairside | PNP | Substantially Equivalent | |
| K234014 | Obsidian® NOW | EIH | Substantially Equivalent | |
| K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) | LRK | Substantially Equivalent | |
| K231097 | Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems | NHA | Substantially Equivalent | |
| K223496 | Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems | NHA | Substantially Equivalent | |
| K231347 | BruxZir™ TintEFX Coloring Liquid | EIH | Substantially Equivalent | |
| K230262 | BruxZir™ Incisal Coloring Liquid | EIH | Substantially Equivalent | |
| K223798 | Glidewell TuffSplint™ Appliance Resin | MQC | Substantially Equivalent | |
| K220816 | BruxZir NOW | EIH | Substantially Equivalent | |
| K220960 | BruxZir Opaque Coloring Liquid | EIH | Substantially Equivalent | |
| K213765 | Glidewell 3DP Denture Base Resin | EBI | Substantially Equivalent | |
| K214102 | Glidewell Appliance Resin, Hard/Soft | MQC | Substantially Equivalent | |
| K213425 | BruxZir Esthetic | EIH | Substantially Equivalent | |
| K211069 | EndSnorZ Sleep Appliance | LRK | Substantially Equivalent | |
| K210694 | Silent Nite Sleep Appliance with the Glidewell Hinge | LRK | Substantially Equivalent | |
| K200131 | BruxZir Steel | EIH | Substantially Equivalent | |
| K191903 | BruxZir GT (Gum Tissue) Color | EIH | Substantially Equivalent | |
| K191222 | Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV | NHA | Substantially Equivalent | |
| K183270 | Silent Nite sl | LRK | Substantially Equivalent | |
| K170044 | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System | NHA | Substantially Equivalent | |
| K162537 | CAD/CAMouflage Milling Block | EBF | Substantially Equivalent | |
| K160979 | Inclusive Abutments | NHA | Substantially Equivalent | |
| K160425 | CAD/CAMouflage Milling Bock | EBF | Substantially Equivalent | |
| K153099 | INCLUSIVE TAPERED IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K151798 | Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System | NHA | Substantially Equivalent | |
| K151375 | Inclusive Titanium Abutments compatible with: Hiossen HG Implant System | NHA | Substantially Equivalent | |
| K143515 | Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants | NHA | Substantially Equivalent | |
| K150872 | BruxZir Anterior Milling Blanks | EIH | Substantially Equivalent | |
| K143353 | Hahn Tapered Implant System | DZE | Substantially Equivalent | |
| K141923 | INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X | NHA | Substantially Equivalent | |
| K143330 | BruxZir Anterior | EIH | Substantially Equivalent | |
| K142118 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE | NHA | Substantially Equivalent | |
| K142115 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT | NHA | Substantially Equivalent | |
| K141887 | OBSIDIAN PRESS (ALL CERAMIC AND POM) | EIH | Substantially Equivalent | |
| K141211 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS | NHA | Substantially Equivalent | |
| K141788 | OBSIDIAN MILLING BLOCKS | EIH | Substantially Equivalent | |
| K133850 | CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE) | EBF | Substantially Equivalent | |
| K130604 | UNIVERSAL PASTE STAINS AND GLAZE | EIH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011649314 | 3011649314 | PRISMATIK DENTALCRAFT, INC. | 2144 Michelson Drive, Irvine, CA 92612 US | 2026 | and 23 more, listed in full below |
| 3027248132 | 3027248132 | Prismatik Dentalcraft, Inc. | 17466 DAIMLER STREET, Irvine, CA 92614 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NDPAccessories, Implant, Dental, Endosseous
- EBZActivator, Ultraviolet, For Polymerization
- PZYAdditively Manufactured, Preformed, Resin Denture Tooth
- KLEAgent, Tooth Bonding, Resin
- EJPArticulators
- NPLBarrier, Animal Source, Intraoral
- NPMBone Grafting Material, Animal Source
- LYCBone Grafting Material, Synthetic
- EJLBur, Dental
- EMACement, Dental
- EBWController, Foot, Handpiece And Cord
- EBGCrown And Bridge, Temporary, Resin
- PNPDental Abutment Design Software For Dental Laboratory
- LRKDevice, Anti-Snoring
- EHJDisk, Abrasive
- QDOFentanyl And Other Opioid Protection Glove
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental
- DZEImplant, Endosseous, Root-Form
- ELWMaterial, Impression
- EBFMaterial, Tooth Shade, Resin
- LZCMedical Glove, Specialty
- MQCMouthguard, Prescription
- LZAPolymer Patient Examination Glove
- KMYPositioner, Tooth, Preformed
- EIHPowder, Porcelain
- EBIResin, Denture, Relining, Repairing, Rebasing
- EGNScissors, Surgical Tissue, Dental
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- EIDSyringe, Restorative And Impression Material
- NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- EHYTray, Impression, Preformed
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2769-2026 | 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 to moderate obstructive sleep apnea (OSA). | Due to device not having FDA Clearance | Class II | Open, Classified | |
| Z-0417-2026 | 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. | Class II | Open, Classified | |
| Z-1856-2025 | 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 dental implants when tissue contact will last less than 1 hour. The Glidewell HT" Implant Twist Drill is used to remove bone from osteotomy during dental implant placement. The initial Twist Drill is used to deepen the osteotomy and establish the trajectory of subsequent drills in the placement of a dental implant. The large Twist Drill is stepped to accmmodate the tapered design of the implant and is available in lengths corresponding to the availble implant lengths. Drill length is calculated to indicate where the top of the implant will reside when fully seated to that depth. The Twist Drill is machined from stainless steel. | Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside. | Class II | Open, Classified | |
| Z-2897-2016 | 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 restorations for anterior and posterior location. | 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. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Prismatik Dentalcraft, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain