510(k) K940769
- Device
- Dentflex Displosable Dental Saliva Ejector
- Applicant
- TERRAFLEX
- 510(k) number
- K940769
- Product code
- DYN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-08-17
- Date received
- 1994-02-18
- Regulation
- 872.6640
- Classification name
- Mouthpiece, Saliva Ejector
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ELI M ORBACH
- Address
- P.O. Box 1310 Efrat 90962 IL
FDA Registration Numbers#
- 1123010
- 3023339277
- 3010598169
- 3012421607
- 3027234828
- 2437780
- 3009049852
- 3008770655
- 3045058049
- 9611450
- 2183301
- 3008494033
- 3007255375
- 1718476
- 3013530901
- 3011707926
- 3008370577
- 9616872
- 3016170492
- 3016798774
- 3010147274
- 3014683120
- 3016758972
- 3008346537
- 3000892153
- 3031184338
- 3013463240
- 3009170227
- 3016789258
- 3004753358
- 3008887731
- 3015045320
- 3007594755
- 3009307523
- 3016426851
- 3017498782
- 3011169597
- 3014437893
- 3027320022
- 3006008984
- 3017910185
- 3026326493
- 1000179416
- 3004425647
- 3017352116
- 3015532219
- 3035858919
- 3015729
- 2523320
- 3033011342
- 2032574
- 3017609565
- 3017220525
- 8044167
- 3010493153
- 3044819802
- 1219113
- 3010864832
- 3012925629
- 3008107579
- 3008269146
- 3004201548
- 3003120666
- 3019103
- 3011215096
- 3044150131
- 3007010296
- 3043648115
- 3022226
- 9611959
- 2435946
- 3010656982
- 9614733
- 3014314985
- 3011091529
- 3004361903
- 3015276580
- 8030905
- 3041704794
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DYN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K935616 | SALIVA EJECTOR DISPOSABLE | Asa Instruments S.R.L. | 1994-03-21 |
| K935758 | HYGOFLEX SALIVA-EJECTOR | J.H.Orsing AB | 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 |