ULS 8-86
FDA 510(k) clearance K863163 · decided 1986-09-22
Clearance details
- K-number
- K863163
- Device name
- ULS 8-86
- Applicant
- American Instrument Manufacturer'S, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-18
- Decision date
- 1986-09-22
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- DYN
- Device class
- 1
- Regulation number
- 872.6640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Eureka, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| SALIVA EJECTOR (K861934) | Carlisle Laboratories, Inc. | 1986-06-09 |
Recalls involving this device
No recalls on record reference this clearance.