Replace One Piece Implant, Ha, Replace One Piece Implant, Tiunite
FDA 510(k) K023952 · Nobel Biocare Uas, Inc.
510(k) numberK023952
Submission
- Device name
- Replace One Piece Implant, Ha, Replace One Piece Implant, Tiunite
- Applicant
- Nobel Biocare Uas, Inc.
Yorba Linda,, CA, US - Received
- November 27, 2002
- Decision date
- January 16, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K260463 | ZEROS Dental Implant SystemDZE · Special | Zeros Co., Ltd. | 08/19/2026SE |
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| 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 |
|---|---|---|
| K050444 | Nobelreplace Adapter, Model 32412NHA · Traditional | 07/07/2005SE |
| K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004NHA · Traditional | 10/20/2004SE |
| K041661 | Nobel Biocare Endosseous ImplantsDZE · Traditional | 08/26/2004SE |
| K041876 | Nobeldirect Od ImplantDZE · Traditional | 08/20/2004SE |
| K041312 | Nobelrondo Dental Ceramic-AluminaEIH · Traditional | 07/23/2004SE |
| K041275 | Procera Abutment OctagonNHA · Traditional | 05/27/2004SE |
| K040573 | Nobel Biocare Permanent Centric Post, Models 31234, 31235, 31236NHA · Traditional | 04/28/2004SE |
| K033724 | Nobel Biocare Centric Post, Models 31234, 31235 and 31236NHA · Traditional | 02/23/2004SE |
| K031345 | Nobel Direct, Models 30937, 30938DZE · Traditional | 07/24/2003SE |
| K030257 | Nobel Perfect Implant SystemDZE · Special | 02/10/2003SE |
Questions and answers
When was Replace One Piece Implant, Ha, Replace One Piece Implant, Tiunite cleared by the FDA?
Replace One Piece Implant, Ha, Replace One Piece Implant, Tiunite (K023952) received a 510(k) decision of Substantially Equivalent on January 16, 2003, 50 days after the submission was received.
What is the product code of K023952?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.