BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MM
FDA 510(k) K121131 · Straumann USA
510(k) numberK121131
Submission
- Device name
- BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MM
- Applicant
- Straumann USA
Andover, MA, US - Received
- April 13, 2012
- Decision date
- June 6, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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 |
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Questions and answers
When was BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MM cleared by the FDA?
BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MM (K121131) received a 510(k) decision of Substantially Equivalent on June 6, 2012, 54 days after the submission was received.
What is the product code of K121131?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.