Implant Center
FDA 510(k) K072030 · Satelec - Acteon Group
510(k) numberK072030
Submission
- Device name
- Implant Center
- Applicant
- Satelec - Acteon Group
Mt. Laurel, NJ, US - Received
- July 24, 2007
- Decision date
- November 19, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K253655 | Angled Screwdriver MED (M-SD090)DZI · Traditional | W&H Dentalwerk Bürmoos GmbH | 07/31/2026SE |
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| K254163 | VarioSurg 4DZI · Traditional | Nakanishi, Inc. | 12/23/2025SE |
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| K240340 | Surgical Drive System (Model: ES70, ES90, E8)DZI · Traditional | Guangdong Jinme Medical Technology Co., Ltd. | 07/18/2024SE |
| K231087 | Guided Surgery KitDZI · Traditional | Implant Direct Sybron Manufacturing, LLC | 08/16/2023SE |
| K192561 | Traus SUS20DZI · Traditional | Saeshin Precision Co., Ltd. | 07/13/2020SE |
| K200265 | Surgical DrillsDZI · Traditional | Implant Direct Sybron Manufacturing, LLC | 06/30/2020SE |
| K192033 | Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC…DZI · Traditional | Bennett Jacoby, Dds, Ms, Inc. | 06/09/2020SE |
| K172137 | Piezotome CubeDZI · Traditional | Satelec - Acteon Group | 05/03/2018SE |
More from Satelec - Acteon Group
| 510(k) | Device | Decision |
|---|---|---|
| K233922 | SP Newtron Can-A; Module Newtron Can-A Emb; Support Xinetic; NWT Can Slim LED Cord G3…ELC · Traditional | 03/11/2024SE |
| K172137 | Piezotome CubeDZI · Traditional | 05/03/2018SE |
| K131906 | Scanwave Pen (with Light Gray Cord), Scanwave Pen (with Medium Gray Cord), Scanwave Pen…EBZ · Abbreviated | 04/11/2014SE |
| K132322 | Newtron P5 XS B.LedELC · Traditional | 03/11/2014SE |
| K132267 | Newtron P5, Newtron P5 B.LedELC · Traditional | 03/10/2014SE |
| K131151 | EndocenterELC · Traditional | 01/16/2014SE |
| K131997 | Newtron BoosterELC · Traditional | 11/26/2013SE |
| K113430 | Proultra Piezo UltrasonicELC · Traditional | 02/23/2012SE |
| K111623 | I-Endo DualEBW · Traditional | 01/10/2012SE |
| K071424 | Pmax Newtron XSELC · Traditional | 08/24/2007SE |
Questions and answers
When was Implant Center cleared by the FDA?
Implant Center (K072030) received a 510(k) decision of Substantially Equivalent on November 19, 2007, 118 days after the submission was received.
What is the product code of K072030?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.