510(k) K190453
- Device
- VisCalor Bulk
- Applicant
- VOCO GmbH
- 510(k) number
- K190453
- Product code
- EBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-04-11
- Date received
- 2019-02-25
- Regulation
- 872.3690
- Classification name
- Material, Tooth Shade, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Th. Plaumann
- Address
- Anton-Flettner-Str. 1-3 Cuxhaven DE 27472 27472
FDA Registration Numbers#
- 3005665377
- 3030515618
- 3005628474
- 3003231822
- 3000268902
- 8030452
- 1410097
- 1413475
- 2437780
- 3026312357
- 3011824442
- 3008882689
- 1032227
- 3003971538
- 3027616
- 1937100
- 3017374693
- 3003449480
- 3032312561
- 2027375
- 3011944170
- 3011814610
- 3008912871
- 1221541
- 3002808149
- 1450653
- 3010664129
- 3011511773
- 3010864832
- 3004491043
- 3043226252
- 3006694515
- 3009482106
- 3012996495
- 3009117991
- 2411797
- 3001124136
- 2244842
- 2081055
- 3031841433
- 9611514
- 3015527825
- 2133714
- 3017183443
- 3004966444
- 3045816931
- 9612352
- 3003114027
- 3012187973
- 9681356
- 3003637274
- 3002789526
- 2424472
- 3015189878
- 3012421607
- 2023950
- 3008582054
- 2429849
- 1424442
- 3008524225
- 3006316962
- 3022516928
- 9680845
- 3026400121
- 8031058
- 3011148229
- 8020994
- 3012441963
- 3013557697
- 3014289665
- 3018283083
- 1000277456
- 3004425647
- 3024749697
- 3009582362
- 1013257
- 3018507299
- 3027526455
- 9680144
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EBF #
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|---|---|---|---|
| K262982 | Core·it Dual | Spident Co., Ltd. | 2026-09-21 |
| K262202 | Cerasmart Forte | GC America, Inc. | 2026-09-10 |
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| 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 |