510(k) K863163
- Device
- Uls 8-86
- Applicant
- AMERICAN INSTRUMENT MANUFACTURER'S, INC.
- 510(k) number
- K863163
- Product code
- DYN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-09-22
- Date received
- 1986-08-18
- Regulation
- 872.6640
- Classification name
- Mouthpiece, Saliva Ejector
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- TERRY SANDERSON
- Address
- P.O. Box 690 Eureka MO US 63025 63025
FDA Registration Numbers#
- 3035858919
- 1423537
- 3033011342
- 9612352
- 3003600526
- 3019103
- 3009170227
- 3034669683
- 8030905
- 3012925629
- 9611450
- 3038632739
- 3011215096
- 3006847937
- 3011434305
- 3008346537
- 3011169597
- 3010147274
- 3011707926
- 3004201548
- 2029234
- 3031582434
- 3025414363
- 3006153346
- 3009049852
- 3004730002
- 3043648115
- 3007594755
- 3016758972
- 3007010296
- 1123010
- 3008770655
- 3014314985
- 3038285060
- 3021023132
- 8021050
- 9611959
- 3009171220
- 1319130
- 2132509
- 3016798774
- 1921846
- 3011526299
- 3013496867
- 1718476
- 2024980
- 3038718579
- 3010364969
- 3023339277
- 3006008984
- 3010864832
- 3006210673
- 3011244061
- 3027234828
- 3015045320
- 3008392711
- 3021386681
- 3016426851
- 3011279497
- 9680507
- 3017498782
- 9612030
- 9614733
- 3013463240
- 3006608997
- 3004605493
- 3004198398
- 3006207978
- 8040278
- 3006542438
- 3017220525
- 3015729
- 8044167
- 2027062
- 1000179416
- 3008107579
- 3004425647
- 3010656982
- 3008370577
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DYN#
| 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 |
| 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 |