Modification to Imtec Sendax Mdi
FDA 510(k) K990983 · Imtec Corp.
510(k) numberK990983
Submission
- Device name
- Modification to Imtec Sendax Mdi
- Applicant
- Imtec Corp.
Ardmore, OK, US - Received
- March 24, 1999
- Decision date
- April 13, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K252031 | Adin Long Dental Implant SystemDZE · Traditional | Adin Dental Implant Systems , Ltd. | 03/23/2026SE |
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| K252168 | Straumann® BLC Implants - Indication WideningDZE · Traditional | Institut Straumann AG | 03/10/2026SE |
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More from Dentis Co., Ltd.
| 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 Modification to Imtec Sendax Mdi cleared by the FDA?
Modification to Imtec Sendax Mdi (K990983) received a 510(k) decision of Substantially Equivalent on April 13, 1999, 20 days after the submission was received.
What is the product code of K990983?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.