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#
- 3006948529
- 3006784738
- 3006608033
- 3017979984
- 3011500388
- 3026525185
- 3013559599
- 3010486573
- 3010864832
- 8043323
- 3009420946
- 3010872518
- 3015140246
- 3008370577
- 3014373983
- 3008770695
- 3043535416
- 3043648115
- 2087362
- 1720839
- 3014268398
- 3007842535
- 3001650535
- 3006633429
- 3008478778
- 3011171738
- 3007329020
- 8043685
- 3030091541
- 3021245739
- 3020966765
- 3008887731
- 3006540944
- 3003045574
- 3005133245
- 3015895045
- 3004777468
- 3005607635
- 3004727093
- 3003491259
- 3033796310
- 3006795917
- 1051594
- 3017959306
- 2024980
- 3011108368
- 3013123677
- 3013120141
- 3012416077
- 3011322033
- 3015139713
- 3011888867
- 3012803257
- 3009937681
- 1043214
- 3005607112
- 1825660
- 3008808082
- 3014775747
- 3029683441
- 3012293198
- 3016445768
- 3015277360
- 3004605493
- 1000179416
- 9617200
- 3010339057
- 2411056
- 3015220912
- 3007485188
- 3030426151
- 1000252128
- 3013927145
- 3006847937
- 3039322966
- 3004111573
- 3011360380
- 3007309332
- 3008381928
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