BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment
FDA 510(k) K162890 · Straumann USA, LLC
510(k) numberK162890
Submission
- Device name
- BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment
- Applicant
- Straumann USA, LLC
Andover, MA, US - Received
- October 17, 2016
- Decision date
- March 8, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K260463 | ZEROS Dental Implant SystemDZE · Special | Zeros Co., Ltd. | 08/19/2026SE |
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| K250806 | Dental Implant SystemDZE · Traditional | A.B. Dental Devices , Ltd. | 06/18/2026SE |
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| K252031 | Adin Long Dental Implant SystemDZE · Traditional | Adin Dental Implant Systems , Ltd. | 03/23/2026SE |
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| 510(k) | Device | Decision |
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| K241575 | Straumann® Anatomic Healing Abutments XC (AHA)NHA · Traditional | 11/11/2024SE |
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| K202942 | Straumann 4 mm Short ImplantsDZE · Traditional | 02/08/2021SE |
| K192401 | Straumann Screw-Retained AbutmentsNHA · Traditional | 04/06/2020SE |
| K190662 | MRI Compatibility for Existing Straumann Dental Implant SystemsDZE · Traditional | 06/17/2019SE |
| K171784 | Straumann Dental Implant SystemDZE · Traditional | 01/19/2018SE |
| K151590 | Straumann RN Gold Abutment for BridgeNHA · Traditional | 03/04/2016SE |
| K151328 | PURE Ceramic ImplantsDZE · Traditional | 01/11/2016SE |
| K150899 | Straumann CARES Titanium Alloy (TAN) AbutmentNHA · Traditional | 09/16/2015SE |
| K151324 | Straumann Variobase for CERECNHA · Traditional | 09/11/2015SE |
Questions and answers
When was BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment cleared by the FDA?
BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment (K162890) received a 510(k) decision of Substantially Equivalent on March 8, 2017, 142 days after the submission was received.
What is the product code of K162890?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.