Irrigated Drill for SS Submerged Screw Plant
FDA 510(k) K894151 · Artech Corp.
510(k) numberK894151
Submission
- Device name
- Irrigated Drill for SS Submerged Screw Plant
- Applicant
- Artech Corp.
Chantilly, VA, US - Received
- June 14, 1989
- Decision date
- September 27, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K261826 | VSP System (Titanium Palatal Splint)DZJ · Traditional | 3D Systems, Inc. | 06/03/2026SE |
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| K242263 | TECHFIT DISRP® SystemDZJ · Traditional | Techfit Digital Surgery, Inc. | 12/11/2024SE |
| K231520 | tmCMF SolutionDZJ · Traditional | Techmah Cmf | 10/02/2023SE |
| K230276 | TECHFIT DISRP® SystemDZJ · Traditional | Techfit Digital Surgery | 06/23/2023SE |
| K223024 | MedCAD AccuPlan SystemDZJ · Traditional | Medcad | 03/07/2023SE |
| K220366 | EmbedMedDZJ · Traditional | 3D Lifeprints UK , Ltd. | 09/30/2022SE |
| K220648 | OMF ASP SystemDZJ · Traditional | Vha Dean | 08/11/2022SE |
| K212570 | OsteoPlan SystemDZJ · Traditional | Osteomed, LLC | 02/11/2022SE |
| K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemDZJ · Traditional | Centermed, Inc. | 06/28/2021SE |
More from Centermed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K911735 | Artech Ardent IV - Type Clylinder ImplantDZE · Traditional | 03/05/1992SE |
| K895267 | Artech Type Ss-Ha Submerged Screw ImplantDZE · Traditional | 04/10/1990SE |
| K891346 | Artech Type SS Submerged Screw ImplantDZE · Traditional | 12/21/1989SE |
| K894160 | Hand Tools for Artech Type SS Submerged Screw ImplDZE · Traditional | 09/28/1989SE |
| K894150 | Counterbore for SS Submerged Screw PlantDZJ · Traditional | 09/27/1989SE |
| K843217 | Hollow Basket Dental ImplantsDZE · Traditional | 10/15/1984SE |
| K843218 | TPS Screw Dental ImplantsDZE · Traditional | 09/27/1984SE |
Questions and answers
When was Irrigated Drill for SS Submerged Screw Plant cleared by the FDA?
Irrigated Drill for SS Submerged Screw Plant (K894151) received a 510(k) decision of Substantially Equivalent on September 27, 1989, 105 days after the submission was received.
What is the product code of K894151?
The FDA product code is DZJ – Driver, Wire, And Bone Drill, Manual, a Class II (moderate risk) device regulated under 21 CFR 872.4120.