510(k) K140976
- Device
- ENADEN FLOW
- Applicant
- KM CORPORATION
- 510(k) number
- K140976
- Product code
- EBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-07-10
- Date received
- 2014-04-16
- 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
- Priscilla Chung
- Address
- 2651 E. Chapman Ave., Suite 110 Fullerton CA US 92831 92831
FDA Registration Numbers#
- 1000272892
- 3015189878
- 3007791519
- 2022039
- 9613953
- 3022296393
- 3012996495
- 3010131268
- 1413475
- 3044819802
- 3004425647
- 9614573
- 3002808149
- 9680845
- 2024312
- 1221541
- 1032227
- 1937100
- 2023950
- 2126683
- 3020702076
- 2411797
- 9612352
- 3045857207
- 2511556
- 2183301
- 3010864832
- 3031841433
- 3003114027
- 3011814610
- 9610902
- 2241860
- 8044164
- 3038718579
- 3045816931
- 9681254
- 3016074824
- 3009432160
- 3010419931
- 1000118628
- 3011148229
- 8030452
- 3008494285
- 2916735
- 2133714
- 8030938
- 3005347791
- 1215305
- 3039433962
- 3024185724
- 3005628474
- 1410097
- 3011221537
- 3003310824
- 9680954
- 3004966444
- 9611385
- 3027241817
- 3012477813
- 3026400121
- 3000268902
- 1281412
- 3042244574
- 3006113314
- 2081055
- 1718476
- 3024749697
- 3027494823
- 3008254125
- 3038295269
- 3011824442
- 3003120666
- 1450653
- 8020994
- 3014615644
- 3013557697
- 3017674095
- 1000625496
- 3008582054
- 3003449480
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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