510(k) K101215
- Device
- NUANCE
- Applicant
- DISCUS DENTAL, LLC
- 510(k) number
- K101215
- Product code
- EBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-05-12
- Date received
- 2010-04-30
- Regulation
- 872.3690
- Classification name
- Material, Tooth Shade, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- WINKIE WONG
- Address
- 8550 Higuera St. Culver City CA US 90232 90232
FDA Registration Numbers#
- 3013934196
- 3008494285
- 3008582406
- 3011430871
- 3031841433
- 9681254
- 9681210
- 3039359767
- 3039433962
- 2022039
- 3044819802
- 3042244574
- 3012312751
- 9610902
- 2241860
- 3003120666
- 3004140838
- 3038715999
- 3014289665
- 9611514
- 2024312
- 3011649314
- 3007113445
- 3008005217
- 9612352
- 3005904906
- 9616128
- 1281412
- 3006694515
- 3025307990
- 2411797
- 3020702076
- 3003794907
- 3008582054
- 9611385
- 8044038
- 3002808149
- 3006291983
- 3012354669
- 1718912
- 3008578884
- 1420052
- 9615399
- 3045891668
- 3009432160
- 3011824442
- 9613953
- 3006367836
- 3022296393
- 2437780
- 1937100
- 2921595
- 3024749697
- 3000219976
- 3018283083
- 3003231822
- 3012627824
- 1450653
- 3001124136
- 3015527825
- 9680954
- 3002807050
- 3013584861
- 3013410675
- 3009117991
- 3016074824
- 3030447506
- 3032312561
- 3005628474
- 1000303432
- 3017674095
- 1000277456
- 3035693034
- 3045857207
- 3012187973
- 3004967419
- 1413475
- 1221541
- 3011944170
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EBF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262982 | Core·it Dual | Spident Co., Ltd. | 2026-09-21 |
| K262202 | Cerasmart Forte | GC America, Inc. | 2026-09-10 |
| K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) | Guilin Kevin Peter Technology Co., Ltd. | 2026-08-31 |
| 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 |
Legacy Summary#
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FDA Review#
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