The Recall Desk

Manufacturer

Prismatik Dentalcraft, Inc.

4 recalls in our database name Prismatik Dentalcraft, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2026-07-29

Of the 4 recalls from Prismatik Dentalcraft, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–4 of 4

  • ModerateFDA (Devices)·Z-2769-2026·2026-07-29

    Silent Nite Sleep Appliance Recalled Due to Lack of FDA Clearance

    Prismatik Dentalcraft, Inc. is recalling Silent Nite Sleep Appliances because the device does not have FDA clearance.

    Product
    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).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0417-2026·2025-11-12

    Dental implant screws recalled because the wrong screw was packaged

    Prismatik Dentalcraft is recalling 208 Inclusive Titanium Screws because an incorrect titanium screw was packaged with the dental implant.

    Product
    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
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1856-2025·2025-06-04

    Glidewell HT Implant Twist Drill recalled due to packaging mix-up

    Prismatik Dentalcraft is recalling Glidewell HT Implant Twist Drill 1.5 x 8 mm devices due to a packaging mix-up that resulted in incorrect finished devices being placed in packages.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2897-2016·2016-10-05

    Prismatik Recalls BruxZir Shaded Dental Restorations Due to Quarantine Failure

    Prismatik Dentalcraft is recalling 150 units of BruxZir Shaded dental restorations because the manufacturer failed to properly identify quarantined lots as such.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide