Home GUDID D0106425410 TPH Spectra ST
Primary DI D0106425410
Brand TPH Spectra ST
Company Dentsply De Trey GmbH
Model 642541
Catalog number 642541
Device description TPH Spectra ST and TPH Spectra ST Effects are visible light-cured, radiopaque, composite restorative for anterior and posterior restorations and cosmetic and functional reshaping of primary and permanent teeth.
Published 2024-02-27
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 true 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 D0106425411 Primary HIBCC 0 D0106425410 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dental composite resin A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Do not freeze. Special Storage Condition, Specify 0 0 Keep out of direct sunlight and protect from moisture. Storage Environment Temperature 2 Degrees Celsius 28 Degrees Celsius
Regulatory Flags# DUNS number 315471722 Device count 13 DM exempt true 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 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 06970006746681 TrusFIL-Flow Flowable Composite Restorative Rizhao HuGe Biomaterials Company, Ltd. EBF 2026-10-25