510(k) K020776
- Device
- MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
- Applicant
- CORONET GROUP NORTH AMERICA, LLC.
- 510(k) number
- K020776
- Product code
- EFW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-06-03
- Date received
- 2002-03-11
- Regulation
- 872.6855
- Classification name
- Toothbrush, Manual
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS E FERARI
- Address
- 181 Dixion Rd. Queensbury, NY US 12804 12804
FDA Registration Numbers#
- 3003896842
- 3043613658
- 3004516804
- 3015337442
- 3008254143
- 3009220523
- 9681207
- 3000182940
- 3013910628
- 3013559599
- 3044819802
- 3005277354
- 3017022128
- 3042278984
- 3042131782
- 3026844237
- 3017417635
- 3011270181
- 3010351588
- 3004756862
- 3011545201
- 3015139713
- 3011322033
- 3007177751
- 3043648115
- 3010686849
- 3007307589
- 3011448174
- 3024860669
- 3029683441
- 3007838093
- 3009937681
- 3004777468
- 3038184769
- 3005271071
- 3007113238
- 3021023132
- 2437780
- 3018130625
- 3017896419
- 2110540
- 3011416038
- 3012118920
- 1417592
- 3016818428
- 3009420946
- 3012773447
- 3006463561
- 2531570
- 3004111573
- 3002911411
- 3015895045
- 3033905868
- 3007485188
- 3011205500
- 3017751928
- 3015045320
- 3016750035
- 3010041486
- 3007649424
- 9615496
- 3009211643
- 3006437215
- 1824619
- 3034669683
- 3011484520
- 3017954358
- 3031978013
- 3038195273
- 3008197908
- 3010278746
- 3008317013
- 1000634183
- 3042903640
- 3003346810
- 3004529379
- 3011108368
- 3006610790
- 3023222182
Source Documents#
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 |
| 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 |
| K930869 | ECO TOOTHBRUSH | Recycla-Dent, Inc. | 1993-05-06 |
Legacy Summary#
summary
FDA Review#
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