Neodent Implant System
FDA 510(k) K123022 · Jjgc Industria E Comercio DE Materiais Dentarios S
510(k) numberK123022
Submission
- Device name
- Neodent Implant System
- Applicant
- Jjgc Industria E Comercio DE Materiais Dentarios S
San Diego, CA, US - Received
- September 28, 2012
- Decision date
- May 17, 2013
- 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 |
|---|---|---|
| K153624 | Neodent Implant SystemNHA · Traditional | 04/15/2016SE |
| K141777 | Neodent Implant SystemDZE · Traditional | 07/20/2015SE |
| K150367 | Neodent Implant SystemNHA · Traditional | 07/13/2015SE |
| K150199 | Neodent Implant SystemDZE · Traditional | 06/15/2015SE |
| K150182 | Neodent Implant System- CM Drive ImplantsDZE · Special | 04/23/2015SE |
| K133696 | Neodent Implant SystemNHA · Traditional | 02/25/2014SE |
| K102769 | Neodent Implant for Orthodontic AnchorageOAT · Traditional | 02/23/2011SE |
| K103084 | Neodent Graft ScrewDZL · Traditional | 02/14/2011SE |
| K101945 | Neodent Implant SystemDZE · Traditional | 01/26/2011SE |
| K101207 | Neodent Implant SystemDZE · Traditional | 08/02/2010SE |
Questions and answers
When was Neodent Implant System cleared by the FDA?
Neodent Implant System (K123022) received a 510(k) decision of Substantially Equivalent on May 17, 2013, 231 days after the submission was received.
What is the product code of K123022?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.