DYN
18 FDA 510(k) clearances · Product code
55 daysmedian time to decision
180 days90th percentile
18clearances measured
FDA profile
- Official device name
- Mouthpiece, Saliva Ejector
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.6640
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2004: 4 · 2005: 7 · 2006: 3 · 2007: 4 · 2009: 9 · 2015: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR (K940769) | Terraflex | 1994-08-17 |
| HYGOFLEX SALIVA-EJECTOR (K935758) | J.H.Orsing AB | 1994-03-21 |
| SALIVA EJECTOR DISPOSABLE (K935616) | Asa Instruments S.R.L. | 1994-03-21 |
| EJECTOR (K924211) | Glenroe Technologies | 1993-03-31 |
| HIGH VAC (K920492) | Hygoplastic, Inc. | 1992-05-11 |
| MINIDAM (K921117) | Delsan Dental Systems | 1992-05-05 |
| SALIVA ABSORBER - DENTAL (K900631) | Kab Gloves Unltd. | 1990-04-04 |
| ORAL ASPIRATOR (K871315) | Endovations | 1987-04-15 |
| TIP, DENTAL SUCTION APPARATUS (K870599) | Military Engineering, Inc. | 1987-03-23 |
| SILIVA EJECTOR/ORAL CAVITY EVACUATOR (K864300) | Ardent Intl., Inc. | 1986-11-24 |
| SALIVA EJECTORS (K863768) | The Medical Group, Inc. | 1986-10-27 |
| ULS 8-86 (K863163) | American Instrument Manufacturer'S, Inc. | 1986-09-22 |
| SALIVA EJECTOR (K861934) | Carlisle Laboratories, Inc. | 1986-06-09 |
| SILENTSLEEP (K801927) | Slumber Research, Inc. | 1980-11-14 |
| TONGUE HOLDER/SALIVA EJECTOR (K800210) | Unitek Corp. | 1980-02-06 |
| SURGICAL ASPIRATOR TIPS (K781592) | Henry Schein, Inc. | 1978-12-04 |
| OPTIONS FOR STAR DENTAL OPUS I (K761264) | Syntex Corp. | 1976-12-23 |
| SALIVA EJECTOR (K760620) | Lorvic Corp. | 1976-09-21 |
Track DYN automatically
Every clearance here is in the API, with alerts when new ones post.