510(k) K902745
- Device
- DEGUFILL (TM)
- Applicant
- DEGUSSA AG
- 510(k) number
- K902745
- Product code
- EBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-08-13
- Date received
- 1990-06-22
- Regulation
- 872.3690
- Classification name
- Material, Tooth Shade, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 3950 S. Clinton Ave. South Plainfield NJ US 07080 07080
FDA Registration Numbers#
- 3045891668
- 9615399
- 1000277456
- 9680954
- 1000118628
- 3012996495
- 2515379
- 3003449480
- 3038295269
- 2014676
- 9613953
- 3001124136
- 9680845
- 2433629
- 3000268902
- 3013410675
- 3004967419
- 3013012934
- 3005347791
- 3007791519
- 3038718579
- 3031841433
- 3010131268
- 3006291983
- 3003637274
- 1013257
- 1450653
- 3003120666
- 1718476
- 3005665377
- 3016074824
- 9611514
- 3017450159
- 3003971538
- 3004491043
- 2024312
- 3009432160
- 8030067
- 3002807420
- 3004966444
- 3005628474
- 3007584711
- 3012354669
- 3012477813
- 3014615644
- 3026400121
- 3005176727
- 9614573
- 1937100
- 2916735
- 3015302693
- 3044819802
- 9681356
- 3018507299
- 3038715999
- 1000625496
- 3042244574
- 3014579161
- 3011649314
- 1223843
- 2022039
- 3012441963
- 1221541
- 3006223010
- 1000303432
- 3015189878
- 3011689956
- 3012389497
- 3010419931
- 3045816931
- 3003621174
- 3008320092
- 3010864832
- 2018957
- 3002808149
- 3006694515
- 2126683
- 3008966075
- 3008582406
- 3003114027
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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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