Prismatik Dentalcraft recalls

3 official recalls and safety alerts involving Prismatik Dentalcraft since 2025-06, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Prismatik Dentalcraft or the relevant agency.

  1. 2026-07-29
  2. US
    Drugs & medicalClass II

    Prismatik Dentalcraft, Inc. recalls Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep…

    Due to device not having FDA Clearance

    FDA · DevicePrismatik Dentalcraft, Inc.U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO,…Official notice →
  3. 2025-11-12
  4. US
    Drugs & medicalClass II

    Prismatik Dentalcraft, Inc. recalls Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog…

    Incorrect titanium screw, packaged with dental implant.

    FDA · DevicePrismatik Dentalcraft, Inc.US Distribution to states of: California, Colorado, Connecticut, Florida,…Official notice →
  5. 2025-06-04
  6. US
    Drugs & medicalClass II

    Prismatik Dentalcraft, Inc. recalls Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The…

    Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.

    FDA · DevicePrismatik Dentalcraft, Inc.U.S Nationwide distribution in the states of KY, MA, MI, NC, VA, and WV.Official notice →