Home GUDID 00195062164439 OptiGuard
Primary DI 00195062164439
Brand OptiGuard
Company Kerr Corporation
Model 26685
Device description Light Cure Composite Surface Sealant; Kit 5ml each
Published 2026-10-29
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name EBF Material, Tooth Shade, Resin
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EBF Material, Tooth Shade, Resin Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00195062164439 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00195062164439 00195062164439 195062164439 0195062164439
GMDN Terms# Term, Definition table Term Definition Dental unfilled resin sealant/coating A non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused.
Regulatory Flags# DUNS number 199354556 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00195062164422 OptiGuard Kerr Corporation EBF 2026-10-29 00195062160332 Build-It FR Kerr Corporation EBF 2026-10-27 00195062160349 Build-It FR Kerr Corporation EBF 2026-10-27 00195062160356 Build-It FR Kerr Corporation EBF 2026-10-27 00195062160363 Build-It FR Kerr Corporation EBF 2026-10-27 00195062160370 Build-It FR Kerr Corporation EBF 2026-10-27 00195062160387 Build-It FR Kerr Corporation EBF 2026-10-27 00195062160394 Build-It FR Kerr Corporation EBF 2026-10-27 00195062160400 Build-It FR Kerr Corporation EBF 2026-10-27 00195062160417 Build-It FR Kerr Corporation EBF 2026-10-27 00195062160424 Build-It FR Kerr Corporation EBF 2026-10-27 00195062160431 Build-It FR Kerr Corporation EBF 2026-10-27 00195062160448 Build-It FR Kerr Corporation EBF 2026-10-27 00195062160455 Build-It FR Kerr Corporation EBF 2026-10-27 00195062160462 Build-It FR Kerr Corporation EBF 2026-10-27 00195062160479 Build-It FR Kerr Corporation EBF 2026-10-27 00195062160486 Build-It FR Kerr Corporation EBF 2026-10-27 00195062160493 Build-It FR Kerr Corporation EBF 2026-10-27 06970006745677 Universal Composite Restorative Rizhao HuGe Biomaterials Company, Ltd. EBF 2026-10-25 06970006746575 TrusFIL-Flow Flowable Composite Restorative Rizhao HuGe Biomaterials Company, Ltd. EBF 2026-10-25 06970006746582 TrusFIL-Flow Flowable Composite Restorative Rizhao HuGe Biomaterials Company, Ltd. EBF 2026-10-25 06970006746599 TrusFIL-Flow Flowable Composite Restorative Rizhao HuGe Biomaterials Company, Ltd. EBF 2026-10-25 06970006746605 TrusFIL-Flow Flowable Composite Restorative Rizhao HuGe Biomaterials Company, Ltd. EBF 2026-10-25 06970006746612 TrusFIL-Flow Flowable Composite Restorative Rizhao HuGe Biomaterials Company, Ltd. EBF 2026-10-25 06970006746629 TrusFIL-Flow Flowable Composite Restorative Rizhao HuGe Biomaterials Company, Ltd. EBF 2026-10-25 06970006746636 TrusFIL-Flow Flowable Composite Restorative Rizhao HuGe Biomaterials Company, Ltd. EBF 2026-10-25 06970006746643 TrusFIL-Flow Flowable Composite Restorative Rizhao HuGe Biomaterials Company, Ltd. EBF 2026-10-25 06970006746650 TrusFIL-Flow Flowable Composite Restorative Rizhao HuGe Biomaterials Company, Ltd. EBF 2026-10-25 06970006746667 TrusFIL-Flow Flowable Composite Restorative Rizhao HuGe Biomaterials Company, Ltd. EBF 2026-10-25 06970006746674 TrusFIL-Flow Flowable Composite Restorative Rizhao HuGe Biomaterials Company, Ltd. EBF 2026-10-25
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