DYN — Mouthpiece, Saliva Ejector Class I
FDA product code DYN covers "Mouthpiece, Saliva Ejector", a Class I medical device regulated under 21 CFR 872.6640. Submissions are reviewed by the Dental panel. At least 18 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DYN
- Device Class
- Class I
- Regulation Number
- 872.6640
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K940769 | terraflex | DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR | August 17, 1994 |
| K935758 | j.h.orsing | HYGOFLEX SALIVA-EJECTOR | March 21, 1994 |
| K935616 | asa instruments | SALIVA EJECTOR DISPOSABLE | March 21, 1994 |
| K924211 | glenroe technologies | EJECTOR | March 31, 1993 |
| K920492 | hygoplastic | HIGH VAC | May 11, 1992 |
| K921117 | delsan dental systems | MINIDAM | May 5, 1992 |
| K900631 | kab gloves unltd | SALIVA ABSORBER - DENTAL | April 4, 1990 |
| K871315 | endovations | ORAL ASPIRATOR | April 15, 1987 |
| K870599 | military engineering | TIP, DENTAL SUCTION APPARATUS | March 23, 1987 |
| K864300 | ardent intl | SILIVA EJECTOR/ORAL CAVITY EVACUATOR | November 24, 1986 |
| K863768 | medical group | SALIVA EJECTORS | October 27, 1986 |
| K863163 | american instrument manufacturer | ULS 8-86 | September 22, 1986 |
| K861934 | carlisle laboratories | SALIVA EJECTOR | June 9, 1986 |
| K801927 | slumber research | SILENTSLEEP | November 14, 1980 |
| K800210 | unitek | TONGUE HOLDER/SALIVA EJECTOR | February 6, 1980 |
| K781592 | henry schein | SURGICAL ASPIRATOR TIPS | December 4, 1978 |
| K761264 | syntex | OPTIONS FOR STAR DENTAL OPUS I | December 23, 1976 |
| K760620 | lorvic | SALIVA EJECTOR | September 21, 1976 |