Imtec Biopin
FDA 510(k) K982951 · Imtec Corp.
510(k) numberK982951
Submission
- Device name
- Imtec Biopin
- Applicant
- Imtec Corp.
Ardmore, OK, US - Received
- August 24, 1998
- Decision date
- June 21, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PINDZL · Traditional | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | 06/27/2025SE |
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| K240321 | MP Pin flat without thread (36BMP000020/MP20)DZL · Traditional | Hager& Meisinger GmbH | 10/17/2024SE |
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| K231599 | Stryker MP, Mandible, HMMF and MMF AXS ScrewsDZL · Traditional | Stryker Leibinger GmbH & Co KG | 08/24/2023SE |
| K222367 | Save GBRDZL · Traditional | Dentis Co., Ltd. | 03/23/2023SE |
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More from Hager& Meisinger GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K081653 | Mdi Mii One-Piece Implant, 2.9MMDZE · Traditional | 09/19/2008SE |
| K081347 | Iluma VisionLLZ · Traditional | 05/28/2008SE |
| K072660 | Endure Implant, Model 5108, 5111, 5113, 5114DZE · Traditional | 12/12/2007SE |
| K053046 | Iluma Orthocat/DentalcatJAK · Abbreviated | 11/08/2005SE |
| K043226 | Endure Implant, Models 3508, 4308, 3520, 4320DZE · Traditional | 01/13/2005SE |
| K042289 | Mdi OrthoDZE · Traditional | 09/15/2004SE |
| K033432 | Lexatite Quick AcrylicEBG · Traditional | 01/15/2004SE |
| K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models Ob-Xx, Sh-Xx, MOB-22, Msh-XxDZE · Traditional | 08/12/2003SE |
| K030243 | Endure Implant, Model 3508,3511,3514,4308,4311,4314DZE · Traditional | 04/23/2003SE |
| K024044 | Saber Tech Implants SystemDZE · Traditional | 02/21/2003SE |
Questions and answers
When was Imtec Biopin cleared by the FDA?
Imtec Biopin (K982951) received a 510(k) decision of Substantially Equivalent on June 21, 1999, 301 days after the submission was received.
What is the product code of K982951?
The FDA product code is DZL – Screw, Fixation, Intraosseous, a Class II (moderate risk) device regulated under 21 CFR 872.4880.