Home GUDID D001N4061350 Therm-o-Flex®
Primary DI D001N4061350
Brand Therm-o-Flex®
Company Dentsply International Inc.
Model A4
Catalog number N406135
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
Rx true
OTC false
Sterile false
Single use false 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 D001N4061350 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 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 true 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 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 D0013010321 Ceramco® 3 Powder Opaque Modifier Sienna 301032 2016-09-21 D0013010361 Ceramco® 3 Powder Opaque Modifier Pink 301036 2016-09-21 D0013010371 Ceramco® 3 Powder Opaque Modifier Ochre 301037 2016-09-21 D0013010481 Ceramco® 3 Paste Opaque A3.5 301048 2016-09-21 D0013010591 Ceramco® 3 Paste Opaque C2 301059 2016-09-21 D0013010701 Ceramco® 3 Paste Opaque Modifiers White 301070 2016-09-21 D0013011031 Ceramco® 3 Opaceous Dentin i1 301103 2016-09-21 D0013011071 Ceramco® 3 Opaceous Dentin A3.5 301107 2016-09-21 D0013011101 Ceramco® 3 Opaceous Dentin i6 301110 2016-09-21 D0013011181 Ceramco® 3 Opaceous Dentin C2 301118 2016-09-21 D0013011221 Ceramco® 3 Opaceous Dentin D3 301122 2016-09-21 D0013011501 Ceramco® 3 Dentin C4 301150 2016-09-21 D0013011611 Ceramco® 3 Dentin Modifier A3.5 301161 2016-09-21 D0013011671 Ceramco® 3 Dentin Modifier Blue 301167 2016-09-21 D0013012001 Ceramco® 3 Natural Enamel White 301200 2016-09-21 D0013012011 Ceramco® 3 Natural Enamel Extra Light 301201 2016-09-21 D0013013221 Ceramco® 3 Overglaze 301322 2016-09-21
Other Devices Sharing Product Codes# 
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