510(k) K944886
- Device
- COLGATE PRECISION MINT WZXED DENTAL FLOSS
- Applicant
- COLGATE-PALMOLIVE CO.
- 510(k) number
- K944886
- Product code
- JES
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-04-27
- Date received
- 1994-10-03
- Regulation
- 872.6390
- Classification name
- Floss, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL J OKARMA
- Address
- P.O. Box 1343 909 River Rd. Piscataway NJ US 08855 08855
FDA Registration Numbers#
- 3020393302
- 3028015088
- 3014566804
- 3033011342
- 3001124136
- 3016426851
- 3017618900
- 3015989868
- 3017195494
- 3013735167
- 3038200340
- 3009566748
- 9680271
- 3020311844
- 3016450032
- 3004585750
- 3021636076
- 3004623350
- 3003965504
- 3007153297
- 3007113238
- 3007502533
- 3014316197
- 3006540944
- 2529851
- 3030228577
- 3011888867
- 9615496
- 3011482376
- 3013557562
- 3025307990
- 3003994666
- 2027062
- 3017751928
- 3009543140
- 2938386
- 3042870861
- 1000300091
- 3030229213
- 8041196
- 3016447301
- 3015220912
- 3030539818
- 3043749713
- 3021023132
- 2081322
- 3008770695
- 2087561
- 3013972866
- 3042272797
- 2126683
- 3013205789
- 3030795695
- 3007420701
- 3008812730
- 3013519273
- 3047524509
- 3038180014
- 3038181748
- 3008343409
- 3038718579
- 3031224575
- 3013600135
- 9615431
- 3044744766
- 3012762648
- 1219313
- 3012773447
- 2920519
- 3004605493
- 3024088964
- 1000634183
- 3010368334
- 3013530901
- 3031841433
- 3010701675
- 2014676
- 3005816808
- 1413787
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| 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 |
| 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#
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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