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#
- 3030795695
- 3030091541
- 3014373983
- 3013504555
- 3012217421
- 3014110830
- 3017959252
- 3006750878
- 2240785
- 3015514846
- 3011813571
- 3014268398
- 3016458459
- 3007353764
- 3015619973
- 1122110
- 3015456958
- 3008344782
- 3007238544
- 3034669683
- 3042262535
- 3008103948
- 3010886592
- 3016010357
- 3033858988
- 3004483571
- 3019804885
- 3014747754
- 3011215096
- 3043088172
- 3016445768
- 3025436467
- 3008648418
- 3005980667
- 1723702
- 3006540014
- 3010852191
- 3021282523
- 3012742764
- 3012133441
- 3013120141
- 3031293716
- 3015527739
- 3024790242
- 3011497834
- 3017618900
- 3027645138
- 3013826894
- 3043648115
- 3013519273
- 3007279848
- 3012896103
- 3003637274
- 3021012565
- 3023192619
- 3021031939
- 3008812730
- 3011353016
- 3004884150
- 3010683450
- 3004069780
- 3009171220
- 3026630
- 3011306968
- 3030536467
- 9613230
- 3022553912
- 3014314529
- 3013662621
- 3017403359
- 3015217632
- 3043711888
- 3017268636
- 3018123168
- 3013496867
- 3030192581
- 3035732161
- 9615428
- 3016815802
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 |