510(k) K222581
- Device
- Stela Automix System
- Applicant
- SDI Limited
- 510(k) number
- K222581
- Product code
- EBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-10-28
- Date received
- 2022-08-26
- 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
- Quynh Jewell
- Address
- 3-15 Brunsdon St., Bayswater Melbourne AU 3153 3153
FDA Registration Numbers#
- 3005665377
- 3044819802
- 3002807420
- 3042244574
- 2437780
- 3013557697
- 3008966075
- 2023950
- 3027241817
- 3007210751
- 2086043
- 3011511773
- 1221541
- 9681254
- 3015189878
- 3026400121
- 3009432160
- 1000625496
- 9612300
- 2241860
- 1723973
- 3009117991
- 9613375
- 3039433962
- 3003794907
- 9681356
- 3020702076
- 3015527825
- 3038715999
- 3004140838
- 3003621174
- 1013257
- 1410097
- 1718476
- 1937100
- 3007791519
- 2133714
- 3001124136
- 3032027578
- 3022296393
- 8030067
- 3012996495
- 8030452
- 3008582054
- 3006367836
- 3027526455
- 3045857207
- 9616128
- 3032163716
- 3012477813
- 3010419931
- 3017183443
- 3004967419
- 2511556
- 1000118628
- 3022545323
- 1721647
- 2183301
- 3010664129
- 3006805063
- 3013012934
- 3011944170
- 3003114027
- 9680845
- 3014683120
- 3004966444
- 3005628474
- 2081055
- 8031058
- 3008578884
- 3023816720
- 3005347791
- 3039359767
- 3009907932
- 3011649314
- 3003120666
- 3004086252
- 2014676
- 9614573
Source Documents#
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases