Home GUDID D001N4061370 Therm-o-Flex®
Primary DI D001N4061370
Brand Therm-o-Flex®
Company Dentsply International Inc.
Model B2
Catalog number N406137
Device description Acetal Resin
Published 2018-09-20
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name EHP CLASP, PREFORMED
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EHP Clasp, Preformed Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D001N4061370 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dental appliance fabrication material, thermoplastic A thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.
Device Sizes# Type, Value, Unit table Type Value Unit Weight 220 Gram
Regulatory Flags# DUNS number 606173334 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D0026243451 Enhance® mini Finishing System 624345 624345 2022-04-11 D0026243551 Enhance® mini Finishing System 624355 624355 2022-04-11 D0026243651 Enhance® mini Finishing System 624365 624365 2022-04-11 D0026243751 Enhance® mini Finishing System 624375 624375 2022-10-13 D0026243851 Enhance® mini Finishing System 624385 624385 2022-04-11 D002624550001 Polytrays 62455000 62455000 2022-07-07 D002624550011 Polytrays 62455001 62455001 2022-07-07 D002624550021 Polytrays 62455002 62455002 2022-07-07 D002624551001 Polytrays 62455100 62455100 2022-07-07 D002624551011 Polytrays 62455101 62455101 2022-07-07 D002624551021 Polytrays 62455102 62455102 2022-07-07 D002624551031 Polytrays 62455103 62455103 2022-07-07 D002624551051 Polytrays 62455105 62455105 2022-07-07 D0026076071 Calibra® Bio Bioceramic Luting Cement 607607 607607 2022-04-20 D0026590301 Palodent® Sectional Matrix System 659030 659030 2019-04-02 D0026590701 Palodent® Sectional Matrix System 659070 659070 2019-04-02 D0026631001 AutoMate® 663100 663100 2019-04-02 D0013010121 Ceramco® 3 Powder Opaque i2/i4 301012 2016-09-21 D0013010211 Ceramco® 3 Powder Opaque D2 301021 2016-09-21 D0013010311 Ceramco® 3 Powder Opaque Modifier Yellow 301031 2016-09-21
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