510(k) K011839
- Device
- DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C
- Applicant
- DOXA CERTEX AB
- 510(k) number
- K011839
- Product code
- EBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-01-17
- Date received
- 2001-06-12
- Regulation
- 872.3690
- Classification name
- Material, Tooth Shade, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JONATHAN S KAHAN
- Address
- 555 13th St., NW Washington DC US 20004 20004
FDA Registration Numbers#
- 3012441963
- 3038718579
- 3008882689
- 9611385
- 3008494285
- 3004425647
- 3030447506
- 3032378317
- 3007584711
- 3006542438
- 3008582406
- 2523320
- 1215305
- 2244842
- 3018507299
- 2024980
- 9680845
- 3005176727
- 3013584861
- 1000625496
- 3022296393
- 3010127342
- 3017183443
- 8044038
- 1221541
- 3016447764
- 2081055
- 1723973
- 8010638
- 2023950
- 2511556
- 3012996495
- 1000118628
- 2411797
- 1223843
- 3008582054
- 3014289665
- 3039433962
- 3025307990
- 3024185724
- 3008320092
- 8010908
- 3018047916
- 2027375
- 3003971538
- 9615399
- 3017674095
- 3006291983
- 3002789526
- 2429849
- 3004146043
- 3002808149
- 3001124136
- 1424442
- 1410097
- 3007210751
- 2437780
- 3003231822
- 3012312751
- 2921595
- 8030938
- 3002807050
- 3006367836
- 3011649314
- 3003120666
- 3004130302
- 3009117991
- 2022039
- 3017374693
- 3004967419
- 8044164
- 3038715999
- 3011824442
- 3038295269
- 3014615644
- 3027616
- 9612300
- 3008912871
- 3043226252
Source Documents#
Other 510(k) Records For Product Code EBF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | DiaDent Group International | 2026-05-19 |
| K260805 | Dual Core | Vericom Co., Ltd. | 2026-05-11 |
| K261357 | Grandio disc multicolor | Voco GmbH | 2026-04-27 |
| K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-27 |
| K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | 2026-04-23 |
| K260661 | Midas Restore | Sprintray, Inc. | 2026-04-15 |
| K253036 | Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2026-04-06 |
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC | 2026-03-11 |
| K254245 | ZAFIRA® | New Stetic, SA | 2026-03-03 |
| K260170 | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-01-21 |
| K252465 | Any-Core | Mediclus Co., Ltd. | 2025-12-05 |
| K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | 2025-11-07 |
| K253236 | G-BLOCK | Graphenano Dental S.L. | 2025-09-29 |
| K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025-09-23 |
| K251946 | G aenial Universal Injectable II | GC America, Inc. | 2025-08-29 |
Legacy Summary#
summary
FDA Review#
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