FDAFDA · Alimentos y medicamentos·N.º oficial Z-1856-2025
Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than 1 hour. The Glidewell HT" Implant Twist Drill is used to remove bone from osteotomy during dental implant placement. The initial Twist Drill is used to deepen the osteotomy and establish the trajectory of subsequent drills in the placement of a dental implant. The large Twist Drill is stepped to accmmodate the tapered design of the implant and is available in lengths corresponding to the availble implant lengths. Drill length is calculated to indicate where the top of the implant will reside when fully seated to that depth. The Twist Drill is machined from stainless steel.
Publicado el 4 de junio de 2025 · Inicio del retiro: 14 de abril de 2025
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Prismatik Dentalcraft, Inc.
- Distribuidor
- U.S Nationwide distribution in the states of KY, MA, MI, NC, VA, and WV.
- Lote
- Glidewell HT Implant Twist Drill ¿1.5 x 8 mm SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V Lot Number: 6254798
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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