4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental Implant
FDA 510(k) K050712 · Bicon, Inc.
510(k) numberK050712
Submission
- Device name
- 4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental Implant
- Applicant
- Bicon, Inc.
Boston, MA, US - Received
- March 17, 2005
- Decision date
- April 22, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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 |
|---|---|---|
| K143524 | Fiber Disks and Blocks (TRINIA)EBF · Traditional | 06/02/2015SE |
| K133608 | TriniaEBF · Abbreviated | 03/14/2014SE |
| K101849 | Bicon Dental Implant System 3.0MM Bicon Dental ImplantDZE · Traditional | 10/01/2010SE |
| K092035 | Bicon Implants with a 2.5MM Internal ConnectionDZE · Traditional | 10/15/2009SE |
| K073368 | 5.0 X 5.0MM Dental Implant and 6.0 X 5.0 Dental ImplantDZE · Traditional | 10/10/2008SE |
| K062044 | The 5.0 X 6.0MM Dental ImplantDZE · Traditional | 11/21/2006SE |
| K051091 | SynthograftLYC · Traditional | 09/01/2005SE |
| K050408 | Bicon Orthodontic Implant SystemDZE · Traditional | 04/07/2005SE |
| K031568 | Biconite Surface TreatmentDZE · Traditional | 11/23/2004SE |
| K042637 | The 5.0 X 6.0MM Dental ImplantDZE · Traditional | 11/15/2004SE |
Questions and answers
When was 4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental Implant cleared by the FDA?
4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental Implant (K050712) received a 510(k) decision of Substantially Equivalent on April 22, 2005, 36 days after the submission was received.
What is the product code of K050712?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.