Straumann Tibrush
FDA 510(k) K111724 · Straumann USA
510(k) numberK111724
Submission
- Device name
- Straumann Tibrush
- Applicant
- Straumann USA
Andover, MA, US - Received
- June 20, 2011
- Decision date
- September 12, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code ELB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170596 | TN-BrushELB · Traditional | Genoss Co., Ltd. | 09/11/2017SE |
| K121114 | Tigran PeribrushELB · Traditional | Tigran Technologies AB | 09/17/2012SE |
| K003640 | Miniendo IIIELB · Traditional | Sybron Dental Specialties, Inc. | 02/22/2001SE |
| K831037 | Air Burbine Handpiece-Dental ScalingELB · Traditional | Taco Dental, Inc. | 05/09/1983SE |
| K782007 | Rotary ScalerELB · Traditional | Star Dental Mfg. Co. | 01/03/1979SE |
More from Star Dental Mfg. Co.
| 510(k) | Device | Decision |
|---|---|---|
| K241575 | Straumann® Anatomic Healing Abutments XC (AHA)NHA · Traditional | 11/11/2024SE |
| K203753 | Straumann Surgical CassettesKCT · Traditional | 07/29/2021SE |
| 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 |
| 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 |
| K150899 | Straumann CARES Titanium Alloy (TAN) AbutmentNHA · Traditional | 09/16/2015SE |
Questions and answers
When was Straumann Tibrush cleared by the FDA?
Straumann Tibrush (K111724) received a 510(k) decision of Substantially Equivalent on September 12, 2011, 84 days after the submission was received.
What is the product code of K111724?
The FDA product code is ELB – Scaler, Rotary, a Class II (moderate risk) device regulated under 21 CFR 872.4840.