Straumann GBR System
FDA 510(k) K011698 · Institut Straumann AG
510(k) numberK011698
Submission
- Device name
- Straumann GBR System
- Applicant
- Institut Straumann AG
Waltham, MA, US - Received
- June 1, 2001
- Decision date
- August 23, 2001
- 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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| K253315 | Straumann Variobase Abutments XC for Bridge/BarNHA · Traditional | 01/22/2026SE |
| K250294 | Straumann® RidgeFit ImplantsDZE · Traditional | 08/12/2025SE |
| K243278 | Custom AbutmentsNHA · Traditional | 02/21/2025SE |
| K243478 | Straumann InLab Validated WorkflowNHA · Traditional | 02/19/2025SE |
| K233252 | Straumann CARES Visual and Nova Dental CADPNP · Traditional | 12/26/2024SE |
| K241391 | Straumann® PURE Ceramic ImplantsDZE · Traditional | 12/10/2024SE |
| K234049 | Straumann® BLC and TLC Implants - Line extensionDZE · Traditional | 03/20/2024SE |
Questions and answers
When was Straumann GBR System cleared by the FDA?
Straumann GBR System (K011698) received a 510(k) decision of Substantially Equivalent on August 23, 2001, 83 days after the submission was received.
What is the product code of K011698?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.