510(k) K841268
- Device
- C-17
- Applicant
- PENTRON CORP.
- 510(k) number
- K841268
- Product code
- EBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-05-22
- Date received
- 1984-03-26
- 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
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3011649314
- 3011814610
- 3026312357
- 8030938
- 3032163716
- 3008582406
- 2018957
- 3011221537
- 1000277456
- 3014289665
- 9615399
- 3015978392
- 3012389497
- 3015189878
- 3003231822
- 2433629
- 3022516928
- 3039433962
- 9681210
- 3031841433
- 3008582054
- 2921595
- 3011824442
- 3008320092
- 3002789526
- 3012996495
- 9611514
- 3009117991
- 3004146043
- 1413475
- 3005904906
- 1281412
- 3011430871
- 3016074824
- 3006291983
- 3045857207
- 8044038
- 3012627824
- 3005628474
- 3022296393
- 3009907932
- 3032027578
- 3042272797
- 3003114027
- 3024749697
- 3006113314
- 2244842
- 3045816931
- 2183301
- 2511556
- 3010419931
- 3002807050
- 3012441963
- 3008912871
- 3017450159
- 9613375
- 2437780
- 1718476
- 3044819802
- 3014683120
- 9680954
- 1215305
- 3012187973
- 3000219976
- 3010864832
- 8010638
- 1032227
- 8044164
- 2014676
- 9612300
- 2241860
- 1424442
- 3013410675
- 8030067
- 3007791519
- 3008524225
- 9611385
- 3038718579
- 3006542438
- 3008005217
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