INTERFACE WHITE

GUDID 00850015110115

DENTAL CAVITY LINER AND BASE

TEMREX CORPORATION

Dental acrylic resin
Primary Device ID00850015110115
NIH Device Record Key651bddc2-3959-44ff-9659-1e69e0860955
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTERFACE WHITE
Version Model Number7101
Company DUNS012072823
Company NameTEMREX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850015110115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EJKLiner, Cavity, Calcium Hydroxide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-05
Device Publish Date2020-01-28

Devices Manufactured by TEMREX CORPORATION

00850015110450 - TEMREX MATRIX BAND IVORY TYPE2022-03-17 A stainless steel band that is used to form a mould around a tooth for the insertion of restorative materials.
00850015110474 - TEMREX SATIN POLISHING PASTE2022-03-17 For restoring the original smoothness and polishing of dental porcelain crowns, inlays, onlays, veneers and bridges; for both i
00850015110498 - TEMREX BITE RELATOR2022-03-17 DENTAL IMPRESSION TRAY AND INSERT
00850015110511 - TEMREX BITE WING TABS2022-03-17 DENTAL X-RAY FILM HOLDER
00850015110535 - TEMREX RITE BITE TRAY2022-03-17 DISPOSABLE DENTAL IMPRESSION TRAY INSERT
00850015110610 - TEMREX TOFFLEMIRE MATRIX BAND2022-03-17 A stainless steel band that is used to form a mould around a tooth for the insertion of restorative materials.
00850015110627 - TEMREX MATRIX RETAINER2022-03-17 A dental device designed to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepar
00850015110634 - TEMREX BRASS "T" MATRIX BAND2022-03-17 A stainless steel band that is used to form a mould around a tooth for the insertion of restorative materials.

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