510(k) K091964
- Device
- CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS
- Applicant
- PROCTER & GAMBLE CO.
- 510(k) number
- K091964
- Product code
- JES
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-09-24
- Date received
- 2009-07-01
- Regulation
- 872.6390
- Classification name
- Floss, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VICTORIA P SCHOFIELD
- Address
- 8700 Mason-Montgomery Rd. Mason OH US 45040 45040
FDA Registration Numbers#
- 2529851
- 3005172118
- 3011118556
- 3043711888
- 3019804885
- 3044819802
- 3023339277
- 1250045
- 3015495690
- 3020311844
- 3011050481
- 9617200
- 8041101
- 3003761382
- 2183301
- 3004789183
- 3017195494
- 3013972866
- 3015050498
- 3006789197
- 3020966765
- 3035374295
- 1825660
- 3010583458
- 3008366788
- 3008328678
- 3026525185
- 3005951403
- 3031288561
- 3043861771
- 3007186430
- 3010401517
- 3014316197
- 3035708505
- 3006540944
- 3017618900
- 3013557562
- 3008808560
- 1226210
- 1051594
- 3009566748
- 3005980667
- 3012047097
- 3008812730
- 3006639573
- 3030671618
- 3025338472
- 3003965504
- 1836161
- 3013645257
- 3001655856
- 3005569927
- 3011409414
- 3005558160
- 3015531959
- 3018258389
- 3033918991
- 3003423103
- 3008346537
- 3003889521
- 3031293716
- 3014468707
- 3042278984
- 3027304051
- 3007143236
- 3004102039
- 3004516804
- 3004096300
- 3005951243
- 3030795695
- 3004605493
- 3015139713
- 3024088964
- 3042277637
- 3007345409
- 3000099306
- 3009349886
- 3006400536
- 3027320022
Source Documents#
Other 510(k) Records For Product Code JES #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K964976 | FLOSSBRUSH WITH FLUORIDE | Flossbrush Interdental Cleaner and Applicator | 1997-05-06 |
| K963746 | IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID | Whitehill Oral Technologies, Inc. | 1996-12-12 |
| K944034 | PERIO-MED DENTAL FLOSS | Whitehill Oral Technologies, Inc. | 1995-07-25 |
| K952091 | VUTLER G.U.M. WITH FLUORIDE | John O. Butler Co. | 1995-06-28 |
| K951917 | JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS | Johnson & Johnson Consumer Products, Inc. | 1995-05-10 |
| K942689 | RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE | Ranir/Dcp Corp. | 1995-04-27 |
| K942690 | RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE | Ranir/Dcp Corp. | 1995-04-27 |
| K943157 | ORAL-B ULTRAFLOSS WITH FLLUORIDE | Oral-B Laboratories | 1995-04-27 |
| K944886 | COLGATE PRECISION MINT WZXED DENTAL FLOSS | Colgate-Palmolive Co. | 1995-04-27 |
| K935440 | JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED | Johnson & Johnson Consumer Products, Inc. | 1994-02-03 |
| K935522 | RANIR DENTAL TAPE MINT WAXED WITH FLOURIDE | Ranir/Dcp Corp. | 1994-01-26 |
| K931353 | FLOSS PLUS | Floss Plus, Inc. | 1993-07-27 |
| K925408 | ORAL-B DENTAL TAPE WITH FLUORIDE | Oral-B Laboratories | 1993-01-28 |
| K925409 | ORAL-B DENTAL FLOSS WITH FLUORIDE | Oral-B Laboratories | 1993-01-28 |
| K921601 | ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE | Ultradent Products, Inc. | 1992-06-16 |
Legacy Summary#
summary
FDA Review#
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