510(k) K952091
- Device
- VUTLER G.U.M. WITH FLUORIDE
- Applicant
- JOHN O. BUTLER CO.
- 510(k) number
- K952091
- Product code
- JES
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-06-28
- Date received
- 1995-05-03
- 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
- CHRISTY CALHOON
- Address
- 4635 W Foster Ave. Chicago IL US 60630 60630
FDA Registration Numbers#
- 3008366788
- 3013205789
- 3015432501
- 1836161
- 3024512680
- 3044744766
- 3007421188
- 3003761382
- 3021460491
- 3004623350
- 3005172118
- 3004305946
- 3010864832
- 3012187973
- 3010278746
- 3006795917
- 3003603939
- 3014468707
- 3010419931
- 3043476844
- 3017181138
- 3008103948
- 3015531959
- 3027320022
- 1226210
- 2531570
- 3017488853
- 3013600135
- 3013566770
- 3014437893
- 3005558160
- 3020393302
- 3030229213
- 3015128224
- 1319147
- 3010583458
- 3006400536
- 3040999583
- 1413787
- 2529851
- 3033011342
- 3003487388
- 3014566804
- 3017618900
- 3031583280
- 3013120141
- 3023222182
- 3006536571
- 8010414
- 3011593329
- 3012421607
- 1250045
- 3012896103
- 3019912897
- 8043323
- 3021245739
- 3007838093
- 2087362
- 3008035828
- 3030671618
- 3042278984
- 3012237070
- 3007113238
- 3010262284
- 3007143236
- 3008344782
- 3030795695
- 3027283275
- 3017954358
- 3011964664
- 3008849197
- 3016450032
- 3014373983
- 1218077
- 3017248108
- 3042272797
- 3003045574
- 3016396121
- 3031191035
Source Documents#
Other 510(k) Records For Product Code JES #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K091964 | CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS | Procter & Gamble Co. | 2009-09-24 |
| 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 |
| 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#
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