510(k) K913030
- Device
- Max-i-probe Irrigation System
- Applicant
- SMITH & NEPHEW, INC.
- 510(k) number
- K913030
- Product code
- EFS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-09-30
- Date received
- 1991-07-09
- 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
- JOHN NAYLER
- Address
- 9400 King St. Franklin Park IL US 60131 60131
FDA Registration Numbers#
- 3005256634
- 3006750878
- 3043667922
- 1063974
- 3025436467
- 3013298431
- 3017959252
- 3011300255
- 3007607709
- 3026025701
- 3014266447
- 3007711548
- 3010701675
- 3011808242
- 3015456958
- 3043613658
- 3010872518
- 3003637274
- 3034669683
- 3013801623
- 3007956657
- 3014373983
- 3010683450
- 3013496867
- 3026164517
- 3015217632
- 3012742764
- 3043648115
- 2031532
- 3007353764
- 3014268398
- 9680012
- 3015965671
- 3027320022
- 3011171738
- 3039435282
- 3015526995
- 3008770703
- 3017268636
- 3030091541
- 3021245739
- 3007958831
- 3016815802
- 3010886592
- 3017177487
- 3030536467
- 3015527739
- 3023192619
- 3043512617
- 3031293716
- 3013600135
- 3015532219
- 3013353014
- 3005607635
- 3017618900
- 3003491259
- 3027344647
- 3011824442
- 3019804885
- 3021422553
- 3011353016
- 3013120141
- 3012803257
- 3024790242
- 3018077257
- 3012134907
- 1723702
- 3011497834
- 3004623350
- 3027605738
- 3012421607
- 3021031939
- 3014747754
- 3006174295
- 1825660
- 3014110830
- 3024172597
- 3027315350
- 3023895623
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 |
| 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 |