510(k) K130186
- Device
- DENTEK EASY BRUSH WITH FLUORIDE
- Applicant
- DENTEK ORAL CARE, INC.
- 510(k) number
- K130186
- Product code
- EFW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-07-15
- Date received
- 2013-01-25
- Regulation
- 872.6855
- Classification name
- Toothbrush, Manual
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LINDA GILES
- Address
- 307 Excellence Way Maryville TN US 37801 37801
FDA Registration Numbers#
- 3004727093
- 3005172118
- 3013927145
- 3021422553
- 3043711888
- 3019804885
- 1066056
- 3044819802
- 3024860669
- 1250045
- 3043049068
- 3002762071
- 9617200
- 3005271071
- 3002951228
- 3030426151
- 3003761382
- 2183301
- 3009124884
- 3004789183
- 3017195494
- 9616088
- 2082295
- 3013972866
- 3015050498
- 3014151911
- 3006789197
- 3009420946
- 3020966765
- 3012416077
- 1825660
- 3021171300
- 3015045320
- 3026986849
- 3010583458
- 3008366788
- 3004488394
- 2438774
- 3013779383
- 3008328678
- 3026525185
- 3005951403
- 3007186430
- 1067084
- 3006463561
- 3006391900
- 3014316197
- 3035708505
- 8030358
- 3027605322
- 3006540944
- 3006210673
- 3030726486
- 2411056
- 3008395516
- 2431166
- 3013557562
- 3014775747
- 1051594
- 3006608033
- 3011210208
- 3006691310
- 3005980667
- 3008346752
- 3008478778
- 3012047097
- 3013520830
- 3008812730
- 3007307589
- 3006639573
- 3010028831
- 3009130317
- 3003799843
- 3013185096
- 3025338472
- 3003965504
- 1836161
- 3008427684
- 3008191511
Source Documents#
Other 510(k) Records For Product Code EFW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K121165 | BEAM BRUSH/BEAM APP | Beam Technologies, LLC | 2012-06-21 |
| K102871 | SILVER CARE ANITBACTERIAL TOOTHBRUSH | Piave Spazzolificio S.P.A. | 2011-10-03 |
| K073224 | ORAL-B SUB-BRAND MANUAL TOOTHBRUSH | Procter & Gamble | 2008-02-06 |
| K021383 | ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL | Agion Technologies, LLC | 2002-07-17 |
| K020776 | MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS | Coronet Group North America, LLC | 2002-06-03 |
| K000290 | LAZERSMILE, LAZERWHITE | Biolase Technology, Inc. | 2000-04-14 |
| K994144 | TOOTHBRUSH WASH | Cal Huech, Inc. | 2000-03-02 |
| K992435 | BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER | Azo Enterprises | 1999-10-15 |
| K980995 | PLAQ-ATAQ-I | Ethicare | 1998-08-20 |
| K974761 | BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH | John O. Butler Co. | 1998-06-16 |
| K973236 | CREST TOOTHBRUSH WITH MICROSHIELD | Procter & Gamble Co. | 1998-03-11 |
| K971589 | REACH ANTIBACTERIAL TOOTHBRUSH | Personal Products Co. | 1997-07-24 |
| K955530 | RANIR HI-TECHNOLOGY DENTAL FLOSS | Ranir/Dcp Corp. | 1995-12-28 |
| K950993 | BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH | John O. Butler | 1995-06-02 |
| K930869 | ECO TOOTHBRUSH | Recycla-Dent, Inc. | 1993-05-06 |
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