Interpore Hex Head Implant Restorative Components
FDA 510(k) K912734 · Interpore Intl.
510(k) numberK912734
Submission
- Device name
- Interpore Hex Head Implant Restorative Components
- Applicant
- Interpore Intl.
Irvine, CA, US - Received
- June 20, 1991
- Decision date
- January 8, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K981253 | Ultracon UltrafiltratorFJI · Traditional | 12/11/1998SE |
| K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10…MQV · Traditional | 09/25/1998SE |
| K972842 | Interpore Inducer Bone Graft Delivery SyringeLYC · Traditional | 10/30/1997SE |
| K971036 | Odontit Autogenous Bone Collection DeviceGCY · Traditional | 06/03/1997SE |
| K960945 | Imz Membrane Tack SystemDZL · Traditional | 05/24/1996SE |
| K960371 | Interpore Threaded ImplantDZE · Traditional | 03/08/1996SE |
| K955492 | Interpore Imz Cyl Implant & Cyl Hex ImpltDZE · Traditional | 01/30/1996SE |
| K952167 | Imz Bone Tack SystemDZL · Traditional | 11/21/1995SE |
| K950165 | Interpore Ip 200 Granular Coralline Hydroxyapatite Bone Void Fillers, 425 to 1000…LYC · Traditional | 03/28/1995SE |
| K922872 | Interpore Cylindrical Hex Hydroxyapatite Coated Implant, 3.3 MM Diam.DZE · Traditional | 07/25/1994SE |
Questions and answers
When was Interpore Hex Head Implant Restorative Components cleared by the FDA?
Interpore Hex Head Implant Restorative Components (K912734) received a 510(k) decision of Substantially Equivalent on January 8, 1992, 202 days after the submission was received.
What is the product code of K912734?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.