DYN · Mouthpiece, Saliva Ejector
Dental · 21 CFR 872.6640 · Class 1
Overview
| Product Code | DYN |
|---|---|
| Device Name | Mouthpiece, Saliva Ejector |
| Regulation | 21 CFR 872.6640 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.
Classification Rationale
Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
Recent Cleared Devices (18 of 18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K940769 | DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR | Terraflex | Aug 17, 1994 | SESE |
| K935758 | HYGOFLEX SALIVA-EJECTOR | J.H.Orsing AB | Mar 21, 1994 | SESE |
| K935616 | SALIVA EJECTOR DISPOSABLE | Asa Instruments S.R.L. | Mar 21, 1994 | SESE |
| K924211 | EJECTOR | Glenroe Technologies | Mar 31, 1993 | SESE |
| K920492 | HIGH VAC | Hygoplastic, Inc. | May 11, 1992 | SESE |
| K921117 | MINIDAM | Delsan Dental Systems | May 5, 1992 | SESE |
| K900631 | SALIVA ABSORBER - DENTAL | Kab Gloves Unltd. | Apr 4, 1990 | SESE |
| K871315 | ORAL ASPIRATOR | Endovations | Apr 15, 1987 | SESE |
| K870599 | TIP, DENTAL SUCTION APPARATUS | Military Engineering, Inc. | Mar 23, 1987 | SESE |
| K864300 | SILIVA EJECTOR/ORAL CAVITY EVACUATOR | Ardent Intl., Inc. | Nov 24, 1986 | SESE |
| K863768 | SALIVA EJECTORS | The Medical Group, Inc. | Oct 27, 1986 | SESE |
| K863163 | ULS 8-86 | American Instrument Manufacturer'S, Inc. | Sep 22, 1986 | SESE |
| K861934 | SALIVA EJECTOR | Carlisle Laboratories, Inc. | Jun 9, 1986 | SESE |
| K801927 | SILENTSLEEP | Slumber Research, Inc. | Nov 14, 1980 | SESE |
| K800210 | TONGUE HOLDER/SALIVA EJECTOR | Unitek Corp. | Feb 6, 1980 | SESE |
| K781592 | SURGICAL ASPIRATOR TIPS | Henry Schein, Inc. | Dec 4, 1978 | SESE |
| K761264 | OPTIONS FOR STAR DENTAL OPUS I | Syntex Corp. | Dec 23, 1976 | SESE |
| K760620 | SALIVA EJECTOR | Lorvic Corp. | Sep 21, 1976 | SESE |
Top Applicants
- Unitek Corp. — 1 clearance
- The Medical Group, Inc. — 1 clearance
- Terraflex — 1 clearance
- Syntex Corp. — 1 clearance
- Slumber Research, Inc. — 1 clearance
