Straumann 4 mm Short Implants
FDA 510(k) K202942 · Straumann USA, LLC
510(k) numberK202942
Submission
- Device name
- Straumann 4 mm Short Implants
- Applicant
- Straumann USA, LLC
Andover, MA, US - Received
- September 30, 2020
- Decision date
- February 8, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K190662 | MRI Compatibility for Existing Straumann Dental Implant SystemsDZE · Traditional | 06/17/2019SE |
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| K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…DZE · Traditional | 03/08/2017SE |
| K151590 | Straumann RN Gold Abutment for BridgeNHA · Traditional | 03/04/2016SE |
| K151328 | PURE Ceramic ImplantsDZE · Traditional | 01/11/2016SE |
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Questions and answers
When was Straumann 4 mm Short Implants cleared by the FDA?
Straumann 4 mm Short Implants (K202942) received a 510(k) decision of Substantially Equivalent on February 8, 2021, 131 days after the submission was received.
What is the product code of K202942?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.