HA-1000 & HA-500 Hydroxylapatite-Modification
FDA 510(k) K851367 · Orthomatrix, Inc.
510(k) numberK851367
Submission
- Device name
- HA-1000 & HA-500 Hydroxylapatite-Modification
- Applicant
- Orthomatrix, Inc.
Dublin, CA, US - Received
- April 5, 1985
- Decision date
- May 21, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 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 |
|---|---|---|
| K010738 | Cannulated Plus Screw SystemHWC · Traditional | 08/01/2001SE |
| K001254 | Orthomatrix, Inc. Cerclage SystemJDQ · Traditional | 12/13/2000SE |
| K992856 | Magellan Humeral Intramedullary NailHSB · Traditional | 03/10/2000SE |
| K992850 | Magellan Tibial Intramedullary NailHSB · Traditional | 03/10/2000SE |
| K852766 | HA-1000 & HA-500 Hydroxylapatite Tooth Root SubstiLYC · Traditional | 10/21/1985SE |
| K852765 | HA-2000 HydroxylapatiteLYC · Traditional | 09/23/1985SE |
| K842163 | Ridgematrix 20/40 Mesh, PeriomatrixLYC · Traditional | 08/09/1984SE |
Questions and answers
When was HA-1000 & HA-500 Hydroxylapatite-Modification cleared by the FDA?
HA-1000 & HA-500 Hydroxylapatite-Modification (K851367) received a 510(k) decision of Substantially Equivalent on May 21, 1985, 46 days after the submission was received.
What is the product code of K851367?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.