510(k) K021383
- Device
- ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
- Applicant
- AGION TECHNOLOGIES, LLC.
- 510(k) number
- K021383
- Product code
- EFW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-07-17
- Date received
- 2002-05-02
- 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
- PAUL C FORD
- Address
- 60 Audubon Rd. Wakefield MA US 01880 01880
FDA Registration Numbers#
- 3007307589
- 3013645257
- 3030091541
- 3013557562
- 3013612323
- 3013427445
- 1061124
- 3018130625
- 9710018
- 3011524638
- 3007842535
- 3031583280
- 2436933
- 3013181914
- 3008490140
- 3014268398
- 3038619059
- 3008648418
- 3015220912
- 3003896842
- 3006610790
- 3011964664
- 9710575
- 3013162488
- 3034048670
- 3009926836
- 3006210673
- 2938386
- 3008395516
- 3004776555
- 3010598169
- 9615158
- 3009220523
- 3015062266
- 3043476844
- 3044819802
- 3008770703
- 8043323
- 3010583458
- 1719513
- 3013075752
- 3007177751
- 2024311
- 3007502533
- 3015531959
- 2022474
- 3006130829
- 1000179416
- 3009937681
- 3015337442
- 3017231740
- 3011593329
- 3005607112
- 1423537
- 3006455037
- 3029952735
- 2029234
- 9611594
- 3039395744
- 3012773447
- 3013123677
- 3007485188
- 3017268636
- 3008346752
- 3004395524
- 3011360380
- 3003062321
- 3016447301
- 3003346810
- 3005951243
- 3031293716
- 3030795695
- 3001124136
- 3003994666
- 9615008
- 3042903640
- 3013927145
- 3016450032
- 3013600135
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 |
| 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 |
| K930869 | ECO TOOTHBRUSH | Recycla-Dent, Inc. | 1993-05-06 |
Legacy Summary#
summary
FDA Review#
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