510(k) K905090
- Device
- FEEL FRESH TOOTHBRUSH KIT
- Applicant
- FRESH APPEAL LTD.
- 510(k) number
- K905090
- Product code
- EFW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-01-25
- Date received
- 1990-11-14
- Regulation
- 872.6855
- Classification name
- Toothbrush, Manual
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROGER L TANNERY
- Address
- 13739 Omega Rd. Dallas TX US 75244 75244
FDA Registration Numbers#
- 3003062321
- 3003761382
- 1423537
- 3012499628
- 3004753334
- 3003205012
- 3034669683
- 3011370373
- 3040999583
- 3008849197
- 3006174523
- 3011360380
- 3011524638
- 3012133441
- 2438774
- 3010147274
- 3017417635
- 3007113238
- 3003423103
- 3006463561
- 3033258462
- 3016447301
- 3005816808
- 3015895045
- 3013779383
- 3009937681
- 3013630887
- 3002485596
- 1054241
- 3008687634
- 3002343253
- 3008262609
- 3043476844
- 3005558160
- 3004756862
- 3008808087
- 3033905868
- 2245519
- 3004069780
- 3013779301
- 3014610038
- 3004372768
- 3006639573
- 3018123168
- 3004102507
- 3030192581
- 9615442
- 2183594
- 3038188994
- 3010041486
- 2938386
- 3010864832
- 3014316197
- 3012934891
- 9710299
- 3006852457
- 3014775747
- 3003491259
- 3005133245
- 3011500388
- 3013205789
- 1316367
- 3015045320
- 9614443
- 3014045831
- 3011205500
- 3008317013
- 3019912897
- 3016818428
- 3011279497
- 3010192494
- 9615431
- 1061124
- 3013463240
- 3011416038
- 9710651
- 3001236514
- 3005630901
- 3017751928
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EFW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130186 | DENTEK EASY BRUSH WITH FLUORIDE | Den Tek Oral Care, Inc. | 2013-07-15 |
| 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 |
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