Prismatik Dentalcraft, Inc.
FDA adverse event reports naming Prismatik Dentalcraft, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: PRISMATIK DENTALCRAFT, INC..
- Total reports
- 7,757
- Deaths
- 0
- Injuries
- 4,793
- Malfunctions
- 2,962
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Implant, Endosseous, Root-FormDZE5,694
- Device, Anti-SnoringLRK1,409
- Mouthguard, PrescriptionMQC484
- Accessories, Implant, Dental, EndosseousNDP75
- Abutment, Implant, Dental, EndosseousNHA35
- Powder, PorcelainEIH26
- Retainer, Screw Expansion, OrthodonticDYJ25
- Mouthguard, Migraine/Tension HeadacheOCO4
- Dental Abutment Design Software For Dental LaboratoryPNP2
- Drill, Dental, IntraoralDZA1
Recent recalls
- 2025-11-03Open, ClassifiedEmployee error
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.
- 2025-05-28Open, ClassifiedProcess control
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.
- TerminatedRelease of Material/Component prior to receiving test results
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.
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