Irvine, CA, United States
Prismatik Dentalcraft, Inc. recalls
3 recalls recorded since 2018, most recently on 27 April 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 27 April 2026
- Reason
- Due to device not having FDA Clearance
- Distribution
- U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Ongoing Class II Medical devices
- Recall started
- 30 September 2025
- Reason
- Incorrect titanium screw, packaged with dental implant.
- Distribution
- US Distribution to states of: California, Colorado, Connecticut, Florida, Georgia, Hawaii, Kentucky, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina, Tennessee, Virginia, Washington.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Ongoing Class II Medical devices
- Recall started
- 14 April 2025
- Reason
- Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
- Distribution
- U.S Nationwide distribution in the states of KY, MA, MI, NC, VA, and WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 endosse
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.