510(k) K083811
- Device
- W&H HANDPIECE ANESTO, MODEL: RA-5
- Applicant
- W & H DENTALWERK BUERMOOS GMBH
- 510(k) number
- K083811
- Product code
- EGM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-01-14
- Date received
- 2008-12-22
- Regulation
- 872.4475
- Classification name
- Injector, Jet, Mechanical-powered
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHANN G SCHARL
- Address
- 53 Ignaz-Glaser-Strasse Buermoos AT 5111 5111
FDA Registration Numbers#
- 9613230
- 2225311
- 3008579121
Source Documents#
Other 510(k) Records For Product Code EGM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243427 | QuickSleeper 5 | Dentalhitec | 2025-08-01 |
| K964802 | CYBERJET LOCAL ANESTHESIA SYSTEM | Intra Vantage, Inc. | 1997-05-27 |
| K962017 | HYPODERMIC JET INJECTION APPARATUS | American Jet Injector Corp. | 1996-07-26 |
| K904279 | PAROJECT ANESTHETIC SYRINGE | Ronvig Instruments, Ltd. | 1990-12-07 |
| K864294 | HENKE-JECT PRESSURE SYRINGE (MODIFICATION) | Smith & Nephew, Inc. | 1987-11-04 |
| K864732 | GRADTECH SYRINGE SYSTEM | Gradtech | 1987-04-15 |
| K864861 | INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM | Instrumentations Unltd. | 1987-02-13 |
| K834361 | JSB JET SYRINGE | C.B.S. Biotechnics, Inc. | 1984-03-05 |
| K821273 | MAYO SCISSOR STRAIGHT 6 3/4 | Conphar, Inc. | 1982-05-28 |
| K790193 | MIZZY SYRIJET MARK IV | Mizzy, Inc. | 1979-04-23 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases