Hand Tools for Artech Type SS Submerged Screw Impl
FDA 510(k) K894160 · Artech Corp.
510(k) numberK894160
Submission
- Device name
- Hand Tools for Artech Type SS Submerged Screw Impl
- Applicant
- Artech Corp.
Chantilly, VA, US - Received
- June 14, 1989
- Decision date
- September 28, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code DZE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260463 | ZEROS Dental Implant SystemDZE · Special | Zeros Co., Ltd. | 08/19/2026SE |
| K251188 | UNIQA® Dental Implants SystemDZE · Traditional | Uniqa Dental, Ltd. | 06/25/2026SE |
| K251232 | MegaGen Zygoma Dental Implant SystemDZE · Traditional | Megagen Implant Co., Ltd. | 06/18/2026SE |
| K250806 | Dental Implant SystemDZE · Traditional | A.B. Dental Devices , Ltd. | 06/18/2026SE |
| K260006 | INOSS SystemDZE · Traditional | Inosys, Inc. | 06/17/2026SE |
| K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantDZE · Traditional | Promimic AB | 05/12/2026SE |
| K252031 | Adin Long Dental Implant SystemDZE · Traditional | Adin Dental Implant Systems , Ltd. | 03/23/2026SE |
| K253334 | ZENEX Implant System_Short (R-System)DZE · Traditional | Izenimplant Co., Ltd. | 03/16/2026SE |
| K252168 | Straumann® BLC Implants - Indication WideningDZE · Traditional | Institut Straumann AG | 03/10/2026SE |
| K253493 | Dentis SQ-SL AXEL FixtureDZE · Traditional | Dentis Co., Ltd. | 03/04/2026SE |
More from Dentis Co., Ltd.
| 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 |
| K894151 | Irrigated Drill for SS Submerged Screw PlantDZJ · Traditional | 09/27/1989SE |
| 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 Hand Tools for Artech Type SS Submerged Screw Impl cleared by the FDA?
Hand Tools for Artech Type SS Submerged Screw Impl (K894160) received a 510(k) decision of Substantially Equivalent on September 28, 1989, 106 days after the submission was received.
What is the product code of K894160?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.