510(k) K897053
- Device
- L'll Squirt Gum Oral Rinse Device
- Applicant
- JAMES R. POWELL
- 510(k) number
- K897053
- Product code
- EFS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-08-06
- Date received
- 1989-12-18
- 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
- JAMES R POWELL
- Address
- 480 Roe Ave. Elmira NY US 14901 14901
FDA Registration Numbers#
- 3019912897
- 3015005470
- 3030541643
- 3015050498
- 3013972866
- 3030091541
- 3004623350
- 3024172597
- 3013547731
- 3013428189
- 3008925277
- 3034669683
- 3012725363
- 3006115534
- 3011463882
- 3004483571
- 3016660845
- 3014266447
- 3015526174
- 3006540014
- 3011457702
- 3003637274
- 3010162782
- 3007060769
- 3010262284
- 3027328721
- 3009155756
- 3007607709
- 3007353764
- 3023192619
- 3026630
- 3013185096
- 3019804885
- 9710575
- 3016010357
- 3007740533
- 3025436467
- 3033858988
- 1422443
- 3005607635
- 2240785
- 3011839159
- 3043711888
- 3008770703
- 3017177487
- 3026182452
- 3015217632
- 3005256634
- 3031191035
- 3014314529
- 3000099306
- 3004069780
- 3011215096
- 3031293716
- 3030192581
- 3018975080
- 3021245739
- 3030795695
- 3030671608
- 3015514846
- 3013496867
- 3016445768
- 3015526995
- 3030821459
- 3017406171
- 3024790242
- 3007958831
- 1222304
- 3009768364
- 3013120141
- 3015168527
- 3015527739
- 3011300255
- 3008103948
- 3016661538
- 3000126629
- 3010852191
- 3004361903
- 3027605738
- 3023895623
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EFS#
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|---|---|---|---|
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| 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 |