510(k) K222435
- Device
- Renamel® Microhybrid ;Renamel® Flowable Microhybrid
- Applicant
- Cosmedent, Inc
- 510(k) number
- K222435
- Product code
- EBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-10-11
- Date received
- 2022-08-12
- Regulation
- 872.3690
- Classification name
- Material, Tooth Shade, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Gary Chuven
- Address
- 401 N. Michigan Ave. Suite 2500 Chicago IL US 60611 60611
FDA Registration Numbers#
- 2018957
- 1723973
- 3008494285
- 3017450159
- 3014579161
- 1420052
- 8020994
- 3008912871
- 3005628474
- 3006291983
- 3011824442
- 9613953
- 3017183443
- 3009117991
- 8030938
- 1013257
- 3014289665
- 3007584711
- 1215305
- 1424442
- 3005347791
- 9612352
- 3009582362
- 3004130302
- 3010864832
- 2433629
- 3012187973
- 3022516928
- 3008578884
- 1032227
- 3011430871
- 9610902
- 1281412
- 2027375
- 3004086252
- 3016447764
- 3012477813
- 3003231822
- 3003310824
- 3018283083
- 9680954
- 2241860
- 8031058
- 3009496224
- 2081055
- 2244842
- 3043226252
- 3012996495
- 9616128
- 3012441963
- 3032163716
- 3006223010
- 1000118628
- 9681254
- 2086043
- 2411797
- 3038718579
- 8044038
- 3004491043
- 2126683
- 3008254125
- 3009482106
- 3010419931
- 1223843
- 3035693034
- 2014676
- 3012312751
- 3013012934
- 3008966075
- 3005176727
- 1718476
- 3006542438
- 3024749697
- 3030515618
- 9613375
- 1221541
- 3011944170
- 3004140838
- 3031841433
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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