510(k) K994144
- Device
- TOOTHBRUSH WASH
- Applicant
- CAL HUECH, INC.
- 510(k) number
- K994144
- Product code
- EFW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-03-02
- Date received
- 1999-12-07
- Regulation
- 872.6855
- Classification name
- Toothbrush, Manual
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHERYL A LITTLE
- Address
- 105 Settlers Trl. Warner Robins GA US 31088 31088
FDA Registration Numbers#
- 3008346752
- 3009707093
- 3016750035
- 3025338472
- 3032245645
- 3011210633
- 2431166
- 3013181914
- 1250045
- 3004111573
- 2029275
- 3006400536
- 3013600135
- 3006130829
- 3021636076
- 3009308092
- 3016447301
- 3043840120
- 1910469
- 3031191035
- 1836161
- 3017248108
- 3004102039
- 3013519273
- 3004605493
- 3014316197
- 3027257639
- 3004623350
- 3013123677
- 3012133441
- 2087561
- 3011484062
- 3013972866
- 3014245821
- 3005686375
- 3012684779
- 3010262284
- 3012293198
- 2954286
- 3009130317
- 3021460491
- 3002807267
- 3038180014
- 3001650535
- 3010686849
- 3016072108
- 3004519921
- 3003761382
- 3008343409
- 3010583458
- 3010598169
- 3012360263
- 3004130302
- 3009171220
- 3011182134
- 3024999438
- 3012773447
- 3040313548
- 3004102812
- 3029507159
- 3016872092
- 1061124
- 3017882499
- 3042131782
- 3006847937
- 3010382415
- 3014610038
- 9615496
- 3042277637
- 3030726486
- 3010486573
- 3011545201
- 3018925957
- 3007284437
- 3027328721
- 3004270595
- 3012814434
- 3008849197
- 3009450029
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 |
| 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#
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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