510(k) K993716
- Device
- PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE
- Applicant
- HARRY J. BOSWORTH CO.
- 510(k) number
- K993716
- Product code
- EBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-12-21
- Date received
- 1999-11-02
- 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
- MILDRED M GOLDSTEIN
- Address
- 7227 N. Hamlin Ave. Skokie IL US 60076 60076
FDA Registration Numbers#
- 1721647
- 3003310824
- 3010664129
- 9680954
- 3011649314
- 3012421607
- 9680845
- 3013557697
- 3026312357
- 3017450159
- 3009117991
- 2437780
- 9611385
- 1000303432
- 3007584711
- 3015189878
- 3010127342
- 2081055
- 3042244574
- 1000272892
- 2018957
- 3013934196
- 2183301
- 1013257
- 3017674095
- 8044164
- 3027241817
- 3026400121
- 3027616
- 3008578884
- 3007791519
- 3014289665
- 1718476
- 3012477813
- 8030452
- 3024185724
- 3006694515
- 1723973
- 9612300
- 9681210
- 3005665377
- 3043226252
- 3032378317
- 3014683120
- 3008882689
- 3045816931
- 3008524225
- 9610902
- 3015978392
- 3022545323
- 3016447764
- 2022039
- 3022516928
- 3008320092
- 9614573
- 3011689956
- 3006805063
- 3014615644
- 1000625496
- 3019596325
- 2086043
- 3000268902
- 2024312
- 3012187973
- 3035693034
- 3006367836
- 3009582362
- 3017374693
- 3032027578
- 3005347791
- 3004425647
- 1420052
- 3018507299
- 3002808149
- 3008582406
- 3004966444
- 3014579161
- 2523320
- 2244842
- 9680144
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EBF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262228 | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. | 2026-07-01 |
| K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, 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 |
| K261357 | Grandio disc multicolor | Voco GmbH | 2026-04-27 |
| K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | 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#
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
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