510(k) K771184
- Device
- TOOTHBRUSH, ORTHODONTIC, #0126-0189-00
- Applicant
- HOYT LABORATORIES
- 510(k) number
- K771184
- Product code
- EFW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-07-15
- Date received
- 1977-06-29
- 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#
- 8030647
- 3024337922
- 3006015326
- 3007649424
- 3008352428
- 3017954358
- 3015140246
- 3017910185
- 3004105180
- 3007663061
- 9615431
- 3016072108
- 3008729549
- 3007284437
- 3009219448
- 3010262284
- 3021422553
- 3011171738
- 3015173212
- 3025414363
- 3007502533
- 3013162488
- 3004519921
- 3009707093
- 9615158
- 3004102812
- 3009220523
- 3018123168
- 3012590871
- 3033905868
- 3030795695
- 3013075752
- 3004270595
- 3015128224
- 3035708505
- 3008274190
- 3008478778
- 3003799843
- 3026326493
- 9613415
- 3004096300
- 3005795204
- 3010701675
- 3018269651
- 3005951243
- 3005554774
- 3006852457
- 3029683441
- 3040313548
- 3001313714
- 2218158
- 3007153297
- 3004529379
- 3011210633
- 3015531959
- 3011279497
- 3003346810
- 3006113202
- 3010382415
- 3030426151
- 3011065399
- 3013557562
- 3011983031
- 3011500388
- 3027283275
- 3026986849
- 3008317013
- 1419181
- 3009211643
- 1417592
- 3012041047
- 3009827000
- 3007186430
- 3021023132
- 3009918464
- 3008395516
- 3016450032
- 3009926836
- 3003487388
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