Class II — Prismatik Dentalcraft, Inc.
| Recalling firm | PRISMATIK DENTALCRAFT, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside. |
| 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 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 tape… |
| Quantity | 15 units |
| Distribution | U.S Nationwide distribution in the states of KY, MA, MI, NC, VA, and WV. |
| Initiated | 2025-04-14 |
| Classified | 2025-05-28 |
| Recall number | Z-1856-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Prismatik Dentalcraft, Inc. (Z-1856-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96711/
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