Mouthpiece, Saliva Ejector
FDA product code DYN · Class I (low risk) · 21 CFR 872.6640 · Dental
18510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Military Engineering, Inc. 1
- Terraflex 1
- J.H.Orsing AB 1
- Asa Instruments S.R.L. 1
- Glenroe Technologies 1
- Hygoplastic, Inc. 1
- Delsan Dental Systems 1
- Kab Gloves Unltd. 1
- Endovations 1
- Lorvic Corp. 1
- Ardent Intl., Inc. 1
- The Medical Group, Inc. 1
- American Instrument Manufacturer'S, Inc. 1
- Carlisle Laboratories, Inc. 1
- Slumber Research, Inc. 1
- Unitek Corp. 1
- Henry Schein, Inc. 1
- Syntex Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K940769 | Dentflex Displosable Dental Saliva EjectorDYN · Traditional | Terraflex | 08/17/1994SE |
| K935758 | Hygoflex Saliva-EjectorDYN · Traditional | J.H.Orsing AB | 03/21/1994SE |
| K935616 | Saliva Ejector DisposableDYN · Traditional | Asa Instruments S.R.L. | 03/21/1994SE |
| K924211 | EjectorDYN · Traditional | Glenroe Technologies | 03/31/1993SE |
| K920492 | High VacDYN · Traditional | Hygoplastic, Inc. | 05/11/1992SE |
| K921117 | MinidamDYN · Traditional | Delsan Dental Systems | 05/05/1992SE |
| K900631 | Saliva Absorber - DentalDYN · Traditional | Kab Gloves Unltd. | 04/04/1990SE |
| K871315 | Oral AspiratorDYN · Traditional | Endovations | 04/15/1987SE |
| K870599 | Tip, Dental Suction ApparatusDYN · Traditional | Military Engineering, Inc. | 03/23/1987SE |
| K864300 | Siliva Ejector/Oral Cavity EvacuatorDYN · Traditional | Ardent Intl., Inc. | 11/24/1986SE |
| K863768 | Saliva EjectorsDYN · Traditional | The Medical Group, Inc. | 10/27/1986SE |
| K863163 | Uls 8-86DYN · Traditional | American Instrument Manufacturer'S, Inc. | 09/22/1986SE |
| K861934 | Saliva EjectorDYN · Traditional | Carlisle Laboratories, Inc. | 06/09/1986SE |
| K801927 | SilentsleepDYN · Traditional | Slumber Research, Inc. | 11/14/1980SE |
| K800210 | Tongue Holder/Saliva EjectorDYN · Traditional | Unitek Corp. | 02/06/1980SE |
| K781592 | Surgical Aspirator TipsDYN · Traditional | Henry Schein, Inc. | 12/04/1978SE |
| K761264 | Options for Star Dental Opus IDYN · Traditional | Syntex Corp. | 12/23/1976SE |
| K760620 | Saliva EjectorDYN · Traditional | Lorvic Corp. | 09/21/1976SE |