510(k) K900547
- Device
- WATER PIK(R) W/ADD'L CLAIMS
- Applicant
- TELEDYNE WATER PIK
- 510(k) number
- K900547
- Product code
- EFS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-06-15
- Date received
- 1990-02-05
- Regulation
- 872.6510
- Classification name
- Unit, Oral Irrigation
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- W RUEHMANN
- Address
- 1730 E. Prospect Rd. Fort Collins CO US 80525 80525
FDA Registration Numbers#
- 3008344782
- 3016010357
- 3016170492
- 3027328721
- 3000126629
- 3019887520
- 3013496867
- 1063974
- 3027135885
- 3026025701
- 3013185096
- 1712259
- 3017150671
- 1836161
- 3011463882
- 3004361903
- 3004069780
- 3017618900
- 3013120141
- 3003637274
- 3015989868
- 3005980667
- 3015527463
- 3013735167
- 3012134907
- 3021368823
- 3045058049
- 3006750878
- 3007279848
- 3017816623
- 3007309332
- 3043613658
- 3008975047
- 3026182452
- 3013521677
- 3023341286
- 3027320022
- 2240785
- 3017268636
- 3008494033
- 3007420876
- 3013298431
- 3014266447
- 3009155756
- 3011813571
- 3017403359
- 3006608997
- 3013801623
- 3015140245
- 3021245739
- 3007770329
- 3014468707
- 3007958831
- 3012803257
- 3017494274
- 9614977
- 1836348
- 3006174295
- 3013561919
- 3004623350
- 3016463702
- 3011497834
- 3007353764
- 3009768364
- 3014290918
- 3014110830
- 3015526995
- 3045927242
- 3023895623
- 1723702
- 3027344647
- 3006115534
- 3008648418
- 3024172597
- 3014314529
- 3016630774
- 3005256634
- 3015005470
- 3016445768
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 |
| K923937 | HYDRO FLOSS | Hydro Floss, Inc. | 1994-02-25 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases