510(k) K923937
- Device
- Hydro Floss
- Applicant
- HYDRO FLOSS, INC.
- 510(k) number
- K923937
- Product code
- EFS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-02-25
- Date received
- 1992-08-05
- Regulation
- 872.6510
- Classification name
- Unit, Oral Irrigation
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- EVANS, SR.
- Address
- 404 Business Center Dr. Birmingham AL US 35244 35244
FDA Registration Numbers#
- 3016463702
- 3013298431
- 3023192619
- 3010872518
- 3030536467
- 1825660
- 3030514697
- 3011824442
- 3033858988
- 3007238544
- 3010262284
- 3013972866
- 3013662621
- 3011497834
- 3017403359
- 3042262535
- 3004361903
- 3025436467
- 3014373983
- 3043648115
- 3046158144
- 3010583458
- 3027328721
- 3015527739
- 3049836320
- 3013428189
- 3015140245
- 3011171738
- 3012134907
- 3016630774
- 3007958831
- 3008344782
- 9681479
- 3039435282
- 3043512617
- 3017150671
- 3030501507
- 3009488700
- 3034669683
- 3018123168
- 3016661538
- 3015989868
- 2133714
- 3010683450
- 3016445768
- 3010886592
- 3014268398
- 1417592
- 3027320022
- 3022553912
- 3045058049
- 3003637274
- 3016010357
- 3017959252
- 3012421607
- 3030091541
- 3031191035
- 3007353764
- 3014707731
- 3017833330
- 9615428
- 3000126629
- 3013801623
- 3013370843
- 3017618900
- 3006540014
- 3006572778
- 3010047475
- 3016660845
- 3015220912
- 3015050498
- 3012803257
- 3027605738
- 3015619973
- 3030047599
- 3027341447
- 3010852191
- 3015526995
- 3008494033
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EFS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023232 | SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE | Smartpractice | 2002-12-11 |
| K001493 | DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 | Air Force, Inc. | 2000-10-25 |
| K983374 | AGATHA-A-H2010 | Midian Intl. | 1998-12-23 |
| K964810 | DERMADAM | Ultradent Products, Inc. | 1997-02-10 |
| K952234 | BARRIER ALL FILM | Cottrell, Ltd. | 1995-07-31 |
| K943182 | ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR | Oral-B Laboratories | 1994-09-09 |
| K923711 | PERIOFLEX TIP | Novadent, Ltd. | 1994-05-16 |
| K931380 | WATER PIK PLUS PLAQUE CONTROL SYSTEM | Teledyne Water Pik | 1993-09-20 |
| K923457 | SHOWERFLOSS | Summit Marketing Group, Inc. | 1992-09-01 |
| K922307 | SHOWERFLOSS ORAL IRRIGATION UNIT | Showerfloss, Inc. | 1992-06-16 |
| K921999 | INTERJET(TM) GINGIVAL CARE INSTRUMENT | Bausch & Lomb, Inc. | 1992-06-03 |
| K913030 | MAX-I-PROBE IRRIGATION SYSTEM | Smith & Nephew, Inc. | 1991-09-30 |
| K910832 | OXYFRESH OXYCARE 3000 | Oxyfresh | 1991-04-17 |
| K901955 | PERIOGARD(R) PERIOPEN | Colgate-Palmolive Co. | 1991-04-15 |
| K905188 | PERIO PIK | Teledyne Water Pik | 1991-02-15 |