Secure Soft
FDA 510(k) K021437 · Imtec Corp.
510(k) numberK021437
Submission
- Device name
- Secure Soft
- Applicant
- Imtec Corp.
Ardmore, OK, US - Received
- May 6, 2002
- Decision date
- July 19, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 Secure Soft cleared by the FDA?
Secure Soft (K021437) received a 510(k) decision of Substantially Equivalent on July 19, 2002, 74 days after the submission was received.
What is the product code of K021437?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.