W&H Handpiece Anesto, Model: RA-5
FDA 510(k) K083811 · W&H Dentalwerk Buermoos GmbH
510(k) numberK083811
Submission
- Device name
- W&H Handpiece Anesto, Model: RA-5
- Applicant
- W&H Dentalwerk Buermoos GmbH
Buermoos, AT - Received
- December 22, 2008
- Decision date
- January 14, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EGM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243427 | QuickSleeper 5EGM · Traditional | Dentalhitec | 08/01/2025SE |
| K964802 | Cyberjet Local Anesthesia SystemEGM · Traditional | Intra Vantage, Inc. | 05/27/1997SE |
| K962017 | Hypodermic Jet Injection ApparatusEGM · Traditional | American Jet Injector Corp. | 07/26/1996SE |
| K904279 | Paroject Anesthetic SyringeEGM · Traditional | Ronvig Instruments, Ltd. | 12/07/1990SE |
| K864294 | Henke-Ject Pressure Syringe (Modification)EGM · Traditional | Smith & Nephew, Inc. | 11/04/1987SE |
| K864732 | Gradtech Syringe SystemEGM · Traditional | Gradtech | 04/15/1987SE |
| K864861 | Instrumentations Unlimited Syringe SystemEGM · Traditional | Instrumentations Unltd. | 02/13/1987SE |
| K834361 | JSB Jet SyringeEGM · Traditional | C.B.S. Biotechnics, Inc. | 03/05/1984SE |
| K821273 | Mayo Scissor Straight 6 3/4EGM · Traditional | Conphar, Inc. | 05/28/1982SE |
| K790193 | Mizzy Syrijet Mark IVEGM · Traditional | Mizzy, Inc. | 04/23/1979SE |
More from Mizzy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253776 | Implantmed Plus II & Piezomed Plus II ModuleDZI · Traditional | 06/18/2026SE |
| K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro…ERL · Traditional | 07/03/2025SE |
| K201703 | PROXEO Twist Cordless Polishing System PL-40 HEKX · Traditional | 02/24/2021SE |
| K181858 | Electric Handpiece MotorEBW · Traditional | 03/26/2019SE |
| K171553 | W&H Assistina TwinEFB · Traditional | 12/08/2017SE |
| K143704 | Advanced Air SystemEFB · Traditional | 11/23/2015SE |
| K133488 | PiezomedDZI · Traditional | 10/16/2014SE |
| K100600 | Prosthodontic Screwdriver , Model IA-400EKX · Traditional | 07/09/2010SE |
| K090931 | Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo MotorEKX · Abbreviated | 12/15/2009SE |
| K090548 | Contra-Angle Handpiece Komet OS30EFB · Abbreviated | 06/30/2009SE |
Questions and answers
When was W&H Handpiece Anesto, Model: RA-5 cleared by the FDA?
W&H Handpiece Anesto, Model: RA-5 (K083811) received a 510(k) decision of Substantially Equivalent on January 14, 2010, 388 days after the submission was received.
What is the product code of K083811?
The FDA product code is EGM – Injector, Jet, Mechanical-Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4475.