Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models Ob-Xx, Sh-Xx, MOB-22, Msh-Xx
FDA 510(k) K031106 · Imtec Corp.
510(k) numberK031106
Submission
- Device name
- Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models Ob-Xx, Sh-Xx, MOB-22, Msh-Xx
- Applicant
- Imtec Corp.
Ardmore, OK, US - Received
- April 8, 2003
- Decision date
- August 12, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K033432 | Lexatite Quick AcrylicEBG · Traditional | 01/15/2004SE |
| K030243 | Endure Implant, Model 3508,3511,3514,4308,4311,4314DZE · Traditional | 04/23/2003SE |
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Questions and answers
When was Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models Ob-Xx, Sh-Xx, MOB-22, Msh-Xx cleared by the FDA?
Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models Ob-Xx, Sh-Xx, MOB-22, Msh-Xx (K031106) received a 510(k) decision of Substantially Equivalent on August 12, 2003, 126 days after the submission was received.
What is the product code of K031106?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.