Monoject Endosseous Dental Implant Tool
FDA 510(k) K791326 · Sherwood Medical Co.
510(k) numberK791326
Submission
- Device name
- Monoject Endosseous Dental Implant Tool
- Applicant
- Sherwood Medical Co.
Mchenry, IL, US - Received
- July 12, 1979
- Decision date
- October 17, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K253655 | Angled Screwdriver MED (M-SD090)DZI · Traditional | W&H Dentalwerk Bürmoos GmbH | 07/31/2026SE |
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| 510(k) | Device | Decision |
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| K981365 | Mahurkar 13.5 FR Cuffed Catheter with Curved ExtensionsMSD · Traditional | 11/25/1998SE |
| K960982 | Monoject Blunt I.V. Access Cannula/Monoject Hypodermic Syringe with Blunt I.V. Access…FMI · Traditional | 12/23/1996SE |
| K962880 | Sensi-Touch Combo Spinal/Epidural Regional Anesthesia Delivery SystemCAZ · Traditional | 12/09/1996SESK |
| K960574 | Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray and Thoracic Catheter…FHO · Traditional | 08/05/1996SE |
| K960677 | Kangaroo Jejunal Feeding SystemKNT · Traditional | 05/13/1996SE |
| K960632 | Kangaroo Feeding Tube Placment StyletKNT · Traditional | 05/09/1996SE |
| K955831 | Argyle Aspr-Care Closed Suction SystemBSY · Traditional | 03/28/1996SE |
| K954429 | Kangaroo Entristar Skin-Level Gastrostomy KitKNT · Traditional | 03/08/1996SESK |
| K954525 | Sensi-Touch Epidural Anesthesia FilterBXN · Traditional | 01/19/1996SE |
| K950201 | Argyle(R) Hydrophilic Coated Thoracic CatheterJOL · Traditional | 12/15/1995SE |
Questions and answers
When was Monoject Endosseous Dental Implant Tool cleared by the FDA?
Monoject Endosseous Dental Implant Tool (K791326) received a 510(k) decision of Substantially Equivalent on October 17, 1979, 97 days after the submission was received.
What is the product code of K791326?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.