510(k) K931380
- Device
- WATER PIK PLUS PLAQUE CONTROL SYSTEM
- Applicant
- TELEDYNE WATER PIK
- 510(k) number
- K931380
- Product code
- EFS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-09-20
- Date received
- 1993-03-18
- 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
- CODY RILEY
- Address
- 1730 E. Prospect Rd. Fort Collins CO US 80525 80525
FDA Registration Numbers#
- 3012421607
- 3007238544
- 3007956657
- 3015526174
- 3011463882
- 3010852191
- 3014468707
- 9613230
- 3027328721
- 3030536467
- 3013519273
- 3045058049
- 3011824442
- 3013428189
- 3021031939
- 3011457702
- 3013496867
- 3030091541
- 3011813571
- 3004361903
- 3008770703
- 3014707731
- 3013521677
- 3026164517
- 3010047475
- 3007279848
- 3015965671
- 3012896103
- 3015514846
- 3011710821
- 3017406171
- 3033858988
- 3014373983
- 3010701675
- 3023341286
- 3003637274
- 3011353016
- 2133714
- 3013972866
- 3026182452
- 3013547731
- 3013504555
- 9615428
- 3007353764
- 3009171220
- 3030501507
- 3008103948
- 3014344342
- 3034669683
- 3013801623
- 3013298431
- 3007958831
- 3027315350
- 3016445768
- 3009488700
- 1417592
- 3015050498
- 3016815802
- 3043088172
- 3017494274
- 1723702
- 3026630
- 3017403359
- 3016458459
- 3017618900
- 3013662621
- 3007420876
- 3005980667
- 3010583458
- 3012041047
- 3010162782
- 3021012565
- 3016010357
- 3011300255
- 3011171738
- 3021282523
- 3043667922
- 3011497834
- 3010683450
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 |
| 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 |
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