Mouthpiece, Saliva Ejector
The Saliva Ejector Mouthpiece is a dental device attached to a suction system and placed in the patient's mouth to continuously remove saliva, blood, and water during dental procedures, keeping the oral field clear. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is DYN and the applicable regulation is 21 CFR 872.6640, under the Dental medical specialty.
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Basic Information
- Product Code
- DYN
- Device Class
- FDA class 1
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K940769 | DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR | Aug 17, 1994 | Substantially Equivalent | Terraflex |
| K935758 | HYGOFLEX SALIVA-EJECTOR | Mar 21, 1994 | Substantially Equivalent | J.H.Orsing AB |
| K935616 | SALIVA EJECTOR DISPOSABLE | Mar 21, 1994 | Substantially Equivalent | Asa Instruments S.R.L. |
| K924211 | EJECTOR | Mar 31, 1993 | Substantially Equivalent | Glenroe Technologies |
| K920492 | HIGH VAC | May 11, 1992 | Substantially Equivalent | Hygoplastic, Inc. |
| K921117 | MINIDAM | May 05, 1992 | Substantially Equivalent | Delsan Dental Systems |
| K900631 | SALIVA ABSORBER - DENTAL | Apr 04, 1990 | Substantially Equivalent | Kab Gloves Unltd. |
| K871315 | ORAL ASPIRATOR | Apr 15, 1987 | Substantially Equivalent | Endovations |
| K870599 | TIP, DENTAL SUCTION APPARATUS | Mar 23, 1987 | Substantially Equivalent | Military Engineering, Inc. |
| K864300 | SILIVA EJECTOR/ORAL CAVITY EVACUATOR | Nov 24, 1986 | Substantially Equivalent | Ardent Intl., Inc. |
| K863768 | SALIVA EJECTORS | Oct 27, 1986 | Substantially Equivalent | The Medical Group, Inc. |
| K863163 | ULS 8-86 | Sep 22, 1986 | Substantially Equivalent | American Instrument Manufacturer'S, Inc. |
| K861934 | SALIVA EJECTOR | Jun 09, 1986 | Substantially Equivalent | Carlisle Laboratories, Inc. |
| K801927 | SILENTSLEEP | Nov 14, 1980 | Substantially Equivalent | Slumber Research, Inc. |
| K800210 | TONGUE HOLDER/SALIVA EJECTOR | Feb 06, 1980 | Substantially Equivalent | Unitek Corp. |
| K781592 | SURGICAL ASPIRATOR TIPS | Dec 04, 1978 | Substantially Equivalent | Henry Schein, Inc. |
| K761264 | OPTIONS FOR STAR DENTAL OPUS I | Dec 23, 1976 | Substantially Equivalent | Syntex Corp. |
| K760620 | SALIVA EJECTOR | Sep 21, 1976 | Substantially Equivalent | Lorvic Corp. |
FEI Numbers
This FDA classification entry is associated with 147 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 147 registration numbers. Click on an entry to view related FDA registrations.