Product Code: EBF


Products Classified as EBF

1121Material, Tooth Shade, ResinTooth Shade Resin Material.

Total Product Life Cycle (TPLC) Devices

1121Material, Tooth Shade, ResinTooth Shade Resin Material.

FDA Consensus Standards

Material, Tooth Shade, Resin [32309]21 CFR §872.3690 🔎
Material, Tooth Shade, Resin [37011]21 CFR §872.3690 🔎
Material, Tooth Shade, Resin [32841]21 CFR §872.3690 🔎
Material, Tooth Shade, Resin [37057]21 CFR §872.3690 🔎
Material, Tooth Shade, Resin [38669]21 CFR §872.3690 🔎
Material, Tooth Shade, Resin [38732]21 CFR §872.3690 🔎
Material, Tooth Shade, Resin [31730]21 CFR §872.3690 🔎
Material, Tooth Shade, Resin [38670]21 CFR §872.3690 🔎

Pre-market Notifications for EBF

K222877FREEPRINT CrownDETAX GmbH
K222723AMBARINO High-ClassCreamed GmbH & Co. Produktions- Und Handels KG
K222581Stela Automix SystemSDI Limited
K222583Stela Capsule SystemSDI Limited
K222435Renamel® Microhybrid ;Renamel® Flowable MicrohybridCosmedent, Inc
K221909J-TempUltradent Products, Inc.
K221510TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.
K221255SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowKerr Corporation
K220605Venus Bulk Flow ONEKulzer, LLC
K220329G-CAMGraphenano Dental S.L.
K213339DENU Composite Resin, DENU Flow ResinHDI, Inc.
K213343Saremco Print CROWNTECSaremco Dental AG
K2118043Delta CrownDeltaMed GmbH
K211345C-30 Crown KitPerfect Fit Crowns, LLC
K211259Renamel BulkfillCosmedent, Inc

Global Unique Device Identification Database

00366975003706Material, Tooth Shade, Resin
00366975000453Material, Tooth Shade, Resin
00366975000408Material, Tooth Shade, Resin
00366975000392Material, Tooth Shade, Resin
00304040024003MATERIAL, TOOTH SHADE, RESIN
00304040023990MATERIAL, TOOTH SHADE, RESIN
00304040023983MATERIAL, TOOTH SHADE, RESIN
00304040016886MATERIAL, TOOTH SHADE, RESIN
00304040016879MATERIAL, TOOTH SHADE, RESIN
00304040016862MATERIAL, TOOTH SHADE, RESIN
00304040015476MATERIAL, TOOTH SHADE, RESIN
00304040015469MATERIAL, TOOTH SHADE, RESIN
00304040015452MATERIAL, TOOTH SHADE, RESIN
00304040015445MATERIAL, TOOTH SHADE, RESIN
00304040015438MATERIAL, TOOTH SHADE, RESIN

Maude Adverse Events

PERMANENT UNIVERSAL TOOTH FILLING COMPOSITE RESIN SELF CUREPRIME DENTAL MANUFACTURING, INC.2019-10-22
SONICFILL 3 COMPOSITEKERR CORPORATION2019-10-18
VENUS SYR 1 X 4G-A2KULZER GMBH2019-08-01
VENUS SYR 1 X 4G-A2KULZER GMBH2019-07-22
CERAM-X DUODENTSPLY DETREY GMBH2019-06-05
TPH SPECTRA ST EFFECTS COMPULE REFILL SHADE D1DENTSPLY CAULK2019-04-26
VENUS DIAMOND PLT REFILL, SHADE A3KULZER GMBH2019-03-28
VENUS DIAMONDKULZER GMBH2019-03-26
SONICFILL COMPOSITEKERR CORPORATION2019-01-25
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D3M ESPE DENTAL PRODUCTS2018-12-26
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D3M ESPE DENTAL PRODUCTS2018-12-26
CERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVEDENTSPLY DETREY GMBH2018-11-28
PREMISEKERR CORPORATION2018-09-25
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2018-05-22
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2018-05-01
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2018-05-01
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2018-02-15
VENUS COMPOSITEKULZER, LLC2017-08-22
3M ESPE FILTEK SUPREME ULTRA UNIVERSAL3M ESPE DENTAL PRODUCTS2017-08-09
3M ESPE FILTEK BULK FILL POSTERIOR RESTORATIVE3M ESPE DENTAL PRODUCTS2017-07-18
VENUS DIAMONDHERAEUS KULZER GMBH2017-06-27
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-06-06
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-05-04
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-05-04
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-04-04
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-04-04
VARIOLINK VENEERIVOCLAR VIVADENT AG2017-04-04
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-04-04
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-04-04
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-04-04
LAVA ULTIMATE CAD-CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-04-04
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-04-04
LAVA ULTIMATE CAD-CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-04-04
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-04-04
VENUS DIAMONDHERAEUS KULZER GMBH2017-03-23
CERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVEDENTSPLY DETREY GMBH2017-03-16
CERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVEDENTSPLY DETREY GMBH2017-03-16
CERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVEDENTSPLY DETREY GMBH2017-03-16
CERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVEDENTSPLY DETREY GMBH2017-03-16
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-03-09
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-03-09
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-03-09
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-02-24
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-02-24
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-02-24
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-02-24
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-02-24
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-02-24
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-02-24
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC3M ESPE DENTAL PRODUCTS2017-02-24
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