Monoject Endosseous Dental Implant
FDA 510(k) K781060 · Sherwood Medical Industries
510(k) numberK781060
Submission
- Device name
- Monoject Endosseous Dental Implant
- Applicant
- Sherwood Medical Industries
Mchenry, IL, US - Received
- June 26, 1978
- Decision date
- August 14, 1978
- 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 |
|---|---|---|
| K801070 | Sherwood Disposable Endometrial SamplesHHK · Traditional | 07/21/1980SE |
| K801071 | Lancer Glucose Rate Reagent KitCGA · Traditional | 05/23/1980SE |
| K792014 | Lancer L-Ina Buffer, Polymer, Wash SoluJZW · Traditional | 11/13/1979SE |
| K792013 | Lancer L-Ina Human Reference SerumJIX · Traditional | 11/13/1979SE |
| K782077 | Lancer Ice CubeJRM · Traditional | 04/03/1979SE |
| K790523 | Argyle Esophageal StethoscopeBZW · Traditional | 03/27/1979SE |
| K790196 | Monoject Arterial Blood Sampling DeviceCBT · Traditional | 03/13/1979SE |
| K790197 | Reagent Kit, Lancer GlucoseJJF · Traditional | 03/12/1979SE |
| K781459 | Monoject Scale MagnifierHJY · Traditional | 10/24/1978SE |
| K772149 | Lancer Biopsy HolderKER · Traditional | 11/22/1977SE |
Questions and answers
When was Monoject Endosseous Dental Implant cleared by the FDA?
Monoject Endosseous Dental Implant (K781060) received a 510(k) decision of Substantially Equivalent on August 14, 1978, 49 days after the submission was received.
What is the product code of K781060?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.