510(k) K101603
- Device
- BEAUTIFIL FLOW PLUS
- Applicant
- SHOFU DENTAL CORP.
- 510(k) number
- K101603
- Product code
- EBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-08-23
- Date received
- 2010-06-08
- 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
- DAVID P MORAIS
- Address
- 1225 Stone Dr. San Marcos CA US 92078 92078
FDA Registration Numbers#
- 1221541
- 2433629
- 3009496224
- 3005904906
- 3004966444
- 3014289665
- 3027494823
- 3013410675
- 3012441963
- 3007791519
- 3002807420
- 3013934196
- 3003310824
- 2241860
- 1000272892
- 9681356
- 3016074824
- 3010864832
- 3027616
- 3010131268
- 2126683
- 3012187973
- 1281412
- 1223843
- 3008966075
- 3024185724
- 2086043
- 3008254125
- 3042244574
- 2511556
- 3017674095
- 3038718579
- 8044164
- 8030067
- 9610902
- 3006367836
- 9613375
- 3012996495
- 3012312751
- 3022296393
- 3010419931
- 3013012934
- 2515379
- 3001124136
- 3009482106
- 3003231822
- 3018047916
- 3045891668
- 1937100
- 9615399
- 2523320
- 9613348
- 1215305
- 3006694515
- 9680845
- 3004146043
- 9613953
- 9681210
- 3030447506
- 3044819802
- 3045816931
- 3011430871
- 9680144
- 3011221537
- 3032378317
- 3017374693
- 2424472
- 3003971538
- 3005347791
- 3008320092
- 3006316962
- 9612352
- 3018283083
- 3006223010
- 3005628474
- 3032027578
- 3002808149
- 9616128
- 9611514
- 9614573
Source Documents#
Other 510(k) Records For Product Code EBF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, Inc. | 2026-07-01 |
| K262228 | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. | 2026-07-01 |
| K261246 | SRGC-06 | GC America, Inc. | 2026-06-18 |
| K261093 | DIAFIL | DiaDent Group International | 2026-06-02 |
| 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 |
| K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-27 |
| K261357 | Grandio disc multicolor | Voco GmbH | 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 |
Legacy Summary#
summary
FDA Review#
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