510(k) K812362
- Device
- DISP. TOOTHBRUSH W/3 G. TUBE OF TOOTHPST
- Applicant
- JDM COMMODITIES
- 510(k) number
- K812362
- Product code
- EFW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-11-20
- Date received
- 1981-08-20
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3007113231
- 3010598169
- 1063242
- 3027234828
- 9680934
- 3011175600
- 3033815781
- 3017249486
- 2245519
- 3013735167
- 3038620646
- 2183301
- 3004111573
- 3011484062
- 3014468707
- 3039396072
- 2438774
- 2431166
- 3000099306
- 3008346537
- 3018258389
- 3030229213
- 3010486573
- 3013577163
- 3042131782
- 3013428189
- 2022474
- 3043269767
- 3009881291
- 3013779301
- 3002762071
- 3017910185
- 1000179416
- 3005904818
- 3007842535
- 3005172118
- 3029507159
- 3004776555
- 3038188994
- 3007329020
- 3013927145
- 3010864832
- 1000308786
- 3007420701
- 9611594
- 3004777468
- 3017959306
- 3008490140
- 2411056
- 3011322033
- 3010278746
- 3003399181
- 3008352428
- 3012237070
- 3043049068
- 3009526336
- 3008076203
- 3015062266
- 3014564970
- 3006633429
- 3004134939
- 3011052946
- 3010701675
- 3008254143
- 3007517215
- 2183594
- 2126683
- 3013120141
- 3008770703
- 3003799843
- 3016872092
- 3010041486
- 3003559457
- 3011191212
- 3009410543
- 3034669683
- 3003062321
- 1423537
- 2920519
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