Product code DYN
- Device name
- Mouthpiece, Saliva Ejector
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6640
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K940769 | DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR | Terraflex | 1994-08-17 |
| K935758 | HYGOFLEX SALIVA-EJECTOR | J.H.Orsing AB | 1994-03-21 |
| K935616 | SALIVA EJECTOR DISPOSABLE | Asa Instruments S.R.L. | 1994-03-21 |
| K924211 | EJECTOR | Glenroe Technologies | 1993-03-31 |
| K920492 | HIGH VAC | Hygoplastic, Inc. | 1992-05-11 |
| K921117 | MINIDAM | Delsan Dental Systems | 1992-05-05 |
| K900631 | SALIVA ABSORBER - DENTAL | Kab Gloves Unltd. | 1990-04-04 |
| K871315 | ORAL ASPIRATOR | Endovations | 1987-04-15 |
| K870599 | TIP, DENTAL SUCTION APPARATUS | Military Engineering, Inc. | 1987-03-23 |
| K864300 | SILIVA EJECTOR/ORAL CAVITY EVACUATOR | Ardent Intl., Inc. | 1986-11-24 |
| K863768 | SALIVA EJECTORS | The Medical Group, Inc. | 1986-10-27 |
| K863163 | ULS 8-86 | American Instrument Manufacturer'S, Inc. | 1986-09-22 |
| K861934 | SALIVA EJECTOR | Carlisle Laboratories, Inc. | 1986-06-09 |
| K801927 | SILENTSLEEP | Slumber Research, Inc. | 1980-11-14 |
| K800210 | TONGUE HOLDER/SALIVA EJECTOR | Unitek Corp. | 1980-02-06 |
| K781592 | SURGICAL ASPIRATOR TIPS | Henry Schein, Inc. | 1978-12-04 |
| K761264 | OPTIONS FOR STAR DENTAL OPUS I | Syntex Corp. | 1976-12-23 |
| K760620 | SALIVA EJECTOR | Lorvic Corp. | 1976-09-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D77162950AS1 | Dental City | ICP, INC. | 2026-05-27 |
| 07615208536706 | Optragate Dry Control | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2025-12-04 |
| 07615208536744 | Optragate Dry Control | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2025-12-04 |
| 07615208536874 | Optragate Dry Control | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2025-12-04 |
| 10304040186524 | Henry Schein | HENRY SCHEIN, INC. | 2024-09-19 |
| 10304040186531 | Henry Schein | HENRY SCHEIN, INC. | 2024-09-19 |
| 10304040179816 | Henry Schein | HENRY SCHEIN, INC. | 2024-02-06 |
| 10304040179809 | Henry Schein | HENRY SCHEIN, INC. | 2024-02-06 |
| 10304040179793 | Henry Schein | HENRY SCHEIN, INC. | 2024-02-06 |
| H66816622161 | Bosworth Flexo | Keystone Industries | 2022-11-30 |
| H66816622171 | Bosworth Flexo | Keystone Industries | 2022-11-30 |
| H66816622181 | Bosworth Flexo | Keystone Industries | 2022-11-30 |
| H66816622191 | Bosworth Flexo | Keystone Industries | 2022-11-30 |
| H66879020001 | Prehma | Keystone Industries | 2022-11-30 |
| H66816622151 | Bosworth Flexo | Keystone Industries | 2022-11-30 |
| H66816622141 | Bosworth Flexo | Keystone Industries | 2022-11-30 |
| H66816622131 | Bosworth Flexo | Keystone Industries | 2022-11-30 |
| H66812002101 | Prehma | Keystone Industries | 2022-11-30 |
| H66812001101 | Prehma | Keystone Industries | 2022-11-30 |
| 10304040142384 | Henry Schein | HENRY SCHEIN, INC. | 2021-03-01 |
| 10304040142391 | Henry Schein | HENRY SCHEIN, INC. | 2021-03-01 |
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| 10686864049286 | MEDICOM SAFEBASICS | AMD Medicom Inc | 2019-01-16 |
| 10304040040185 | Henry Schein | HENRY SCHEIN, INC. | 2019-01-11 |