Product Code: EBI


Products Classified as EBI

1124Resin, Denture, Relining, Repairing, RebasingDenture Relining, Repairing, Or Rebasing Resin.

Total Product Life Cycle (TPLC) Devices

1124Resin, Denture, Relining, Repairing, RebasingDenture Relining, Repairing, Or Rebasing Resin.

FDA Consensus Standards

Resin, Denture, Relining, Repairing, Rebasing [32309]21 CFR §872.3760 🔎
Resin, Denture, Relining, Repairing, Rebasing [35851]21 CFR §872.3760 🔎
Resin, Denture, Relining, Repairing, Rebasing [35869]21 CFR §872.3760 🔎
Resin, Denture, Relining, Repairing, Rebasing [33029]21 CFR §872.3760 🔎
Resin, Denture, Relining, Repairing, Rebasing [37011]21 CFR §872.3760 🔎
Resin, Denture, Relining, Repairing, Rebasing [33028]21 CFR §872.3760 🔎
Resin, Denture, Relining, Repairing, Rebasing [35868]21 CFR §872.3760 🔎
Resin, Denture, Relining, Repairing, Rebasing [37649]21 CFR §872.3760 🔎
Resin, Denture, Relining, Repairing, Rebasing [37055]21 CFR §872.3760 🔎
Resin, Denture, Relining, Repairing, Rebasing [31731]21 CFR §872.3760 🔎
Resin, Denture, Relining, Repairing, Rebasing [37648]21 CFR §872.3760 🔎

Pre-market Notifications for EBI

K222414TERA HARZ DENTUREGraphy Inc.
K221678SprintRay High Impact Denture BaseSprintRay Inc.
K220979SprintRay Denture BaseSprintRay Inc
K220771Stratasys TrueDentStratasys Ltd
K220743CediTECVOCO GmbH
K220680Denture Base PolymersShandong Huge Dental Material Corporation
K220236V-Print DentbaseVoco GmbH
K220042Dentca Base Premium, Dentca Base Hi-ImpactDentca, Inc.
K213994Flexible BlockShandong Huge Dental Material Corporation
K213765Glidewell 3DP Denture Base ResinPrismatik Dentalcraft, Inc.
K2125413Delta Denture Base - 3Delta Denture Bond - 3Delta Denture FixDeltaMed GmbH
K210828DIOnavi-Denture02DIO Corporation
K210298GR-14 Resin SystemPro3dure Medical GmbH
K210189Pac-Dent Denture Base ResinPac-Dent, Inc.
K203641E-Denture ProEnvisionTEC GmbH

Global Unique Device Identification Database

00366975002976Resin, Denture, Relining, Repairing, Rebasing
00366975002808Resin, Denture, Relining, Repairing, Rebasing
00366975002792Resin, Denture, Relining, Repairing, Rebasing
00366975002778Resin, Denture, Relining, Repairing, Rebasing
00366975002761Resin, Denture, Relining, Repairing, Rebasing
00366975002754Resin, Denture, Relining, Repairing, Rebasing
00366975002723Resin, Denture, Relining, Repairing, Rebasing
00366975002693Resin, Denture, Relining, Repairing, Rebasing
00366975002686Resin, Denture, Relining, Repairing, Rebasing
00366975002679Resin, Denture, Relining, Repairing, Rebasing
00366975002655Resin, Denture, Relining, Repairing, Rebasing
00366975002617Resin, Denture, Relining, Repairing, Rebasing
00366975002600Resin, Denture, Relining, Repairing, Rebasing
00304040029459RESIN, DENTURE, RELINING, REPAIRING, REBASING
00304040029435RESIN, DENTURE, RELINING, REPAIRING, REBASING

Maude Adverse Events

COE-SOFTGCAMERICA INC.2020-01-29
HARD LINER CHAIRSIDE RELINE MATERIALUNK2019-10-01
VIPI FLASH LIQUIDDENTSPLY BRAZIL2019-08-08
PALAXPRESSKULZER GMBH - HQ2019-07-25
PALAXPRESSKULZER GMBH2019-07-16
PALAXPRESSKULZER GMBH2019-06-13
PALAXPRESS, 500ML LIQUIDKULZER, GMBH2019-06-12
DENTAL BONDING MATERIALUNK2019-04-24
VIPI CRIL PLUS LIQUIDDENTSPLY BRAZIL2019-03-06
VIPI FLASH LIQUIDDENTSPLY BRAZIL2019-03-06
VIPI CRIL PLUS LIQUIDDENTSPLY BRAZIL2019-03-06
LUCITONE? HIPA DENTURE BASE LIQUID 500ML PACKAGEDENTSPLY PROSTHETICS2019-02-28
IVOCAP PREFERENCEIVOCLAR VIVADENT AG2018-12-18
ORTHODONTIC RESIN LIQUID CLEARDENTSPLY CAULK2018-08-22
COE-SOFT 5.5 OZ PROFESSIONAL PACKAGEGC AMERICA INC.2017-06-01
COE-SOFTGC AMERICA2017-03-28
PALADON 65HERAEUS KULZER GMBH2016-12-01
COE-SOFTGC AMERICA INC.2016-11-03
COE-SOFT DENTURE RELINE MATERIALG C AMERICA2016-10-17
PALAXPRESS LIQUID 80MLHERAEUS KULZER GMBH2016-07-12
LUCITONE FRS RESINDENTSPLY PROSTHETICS2016-07-09
LUCITONE 199 DENTURE BASE RESINDENTSPLY PROSTHETICS2016-06-22
CHARISMAHERAEUS KULZER GMBH2016-04-22
PALAXPRESS LIQUIDHERAEUS KULZER GMBH2016-03-01
PALAXPRESS, PINK, 1000G POWDERHERAEUS KULZER GMBH2016-02-03
PALAPRESS VARIO, PINKHERAEUS KULZER GMBH2015-12-16
VISCO-GEL TISSUE TREATMENT MATERIALDENTSPLY DETREY GMBH2015-11-13
LYNAL TISSUE CONDITIONER AND TEMPORARY RELINERDENTSPLY CAULK2015-08-21
COE-SOFTGC AMERICA, INC.2015-06-29
PALADUR PINKHERAEUS KULZER GMBH2015-03-25
LYNAL TISSUE CONDITIONER AND TEMPORARY RELINERDENTSPLY CAULK2015-02-18
PALAPRESS 500GHERAEUS KULZER GMBH2015-01-28
PALXPRESSHERAEUS KULZER GMBH2015-01-13
HYDRO-CAST TISSUE TREATMENTDENTSPLY CAULK2014-12-10
PALAPRESS(R) VARIO RESINHERAEUS KULZER GMBH2014-11-21
PALAPRESSHERAEUS KULZER GMBH2014-11-21
COE-COMFORT ENDENTULOUS TISSUE CONDITIONERGC AMERICA, INC.2014-09-30
INSTA DENTURE RELINE KIT2014-09-10
VISCO-GELDENTSPLY CAULK2014-08-28
LYNAL TISSUE CONDITIONER AND TEMPORARY RELINERDENTSPLY CAULK2014-05-22
LUCITONE LIQUIDDENTSPLY PROSTHETICS2014-03-12
LYNALDENTSPLY CAULK2014-02-13
PALAPRESS VARIOHERAEUS KULZER GMBH2013-09-06
PALAPRESS VARIOHERAEUS KULZER GMBH2013-09-06
PARTIAL DENTUREDENTSPLY INTERNATIONAL2013-04-30
TEMPSPAN GLAZEPENTRON CLINICAL2013-01-07
TEMPSPAN GLAZEPENTRON CLINICAL2013-01-07
PALAXPRESS ULTRA POWDER AND LIQUIDHERAEUS KULZER GMBH2012-11-19
VISCO-GELDENTSPLY CAULK2012-10-17
ORTHODONTIC RESINDENTSPLY CAULK2012-09-19
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