510(k) K781962
- Device
- DIJI-DENT
- Applicant
- J&J TECHNOLOGIES, INC.
- 510(k) number
- K781962
- Product code
- EFW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-12-20
- Date received
- 1978-11-21
- 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#
- 3008191511
- 3019912897
- 3004623350
- 3007177751
- 3010598169
- 3013428189
- 3003799843
- 3034669683
- 3014652222
- 3002911411
- 3038718579
- 3016872092
- 3029507159
- 3006540944
- 3002807267
- 3003618527
- 3015282468
- 3038615914
- 2413727
- 3027328721
- 3018258389
- 3004605493
- 3009420946
- 3011888867
- 3013185096
- 3019804885
- 2938386
- 3014421917
- 3039322966
- 3004789183
- 3017959306
- 3012354669
- 3008366788
- 3027234828
- 3007663061
- 3031191035
- 3030795695
- 3042131782
- 3002762071
- 3005630901
- 3033918991
- 3017249486
- 3013120141
- 3003399181
- 3009935038
- 3013520830
- 3013549008
- 3014296928
- 9710299
- 3007307589
- 3010864832
- 3007165189
- 3006847937
- 3012972093
- 1413787
- 3011484062
- 3013181914
- 3006400536
- 2438774
- 3017268636
- 3004529379
- 3002485596
- 3008076203
- 3015139713
- 2081322
- 3014683120
- 3012416077
- 3033920063
- 2245519
- 3021712195
- 3010382415
- 9616088
- 3007838093
- 8043323
- 3003487388
- 3007113231
- 1034116
- 1054241
- 2183301
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