Iti Distance System
FDA 510(k) K931993 · The Straumann Co.
510(k) numberK931993
Submission
- Device name
- Iti Distance System
- Applicant
- The Straumann Co.
Cambridge, MA, US - Received
- April 23, 1993
- Decision date
- April 26, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 510(k) | Device | Decision |
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| K041070 | Straumann Temporary CopingNHA · Traditional | 07/23/2004SE |
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| K993862 | Modus Sagittal Split PlateJEY · Traditional | 12/29/1999SE |
| K962023 | Plastic Protection Healing CapsDZE · Traditional | 08/15/1996SE |
| K960634 | Titanium Healing CapsDZE · Traditional | 06/18/1996SE |
| K955281 | Endosseous Dental Implant & AccessoriesDZE · Traditional | 03/15/1996SE |
| K955369 | MemfixDZL · Traditional | 01/23/1996SE |
| K941393 | Iti Angled AbutmentDZE · Traditional | 06/14/1995SE |
| K943720 | Iti Transversal Screwing SystemDZE · Traditional | 03/24/1995SE |
Questions and answers
When was Iti Distance System cleared by the FDA?
Iti Distance System (K931993) received a 510(k) decision of Substantially Equivalent on April 26, 1994, 368 days after the submission was received.
What is the product code of K931993?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.