INTERFACE WHITE

GUDID 00850015110115

DENTAL CAVITY LINER AND BASE

TEMREX CORPORATION

Dental acrylic resin

• Primary Device ID: 00850015110115
• NIH Device Record Key: 651bddc2-3959-44ff-9659-1e69e0860955
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTERFACE WHITE
• Version Model Number: 7101
• Company DUNS: 012072823
• Company Name: TEMREX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015110115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K897130

FDA Product Code

• EJK: Liner, Cavity, Calcium Hydroxide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-05
• Device Publish Date: 2020-01-28

Devices Manufactured by TEMREX CORPORATION

• 00850015110450 - TEMREX MATRIX BAND IVORY TYPE: 2022-03-17 A stainless steel band that is used to form a mould around a tooth for the insertion of restorative materials.
• 00850015110474 - TEMREX SATIN POLISHING PASTE: 2022-03-17 For restoring the original smoothness and polishing of dental porcelain crowns, inlays, onlays, veneers and bridges; for both i
• 00850015110498 - TEMREX BITE RELATOR: 2022-03-17 DENTAL IMPRESSION TRAY AND INSERT
• 00850015110511 - TEMREX BITE WING TABS: 2022-03-17 DENTAL X-RAY FILM HOLDER
• 00850015110535 - TEMREX RITE BITE TRAY: 2022-03-17 DISPOSABLE DENTAL IMPRESSION TRAY INSERT
• 00850015110610 - TEMREX TOFFLEMIRE MATRIX BAND: 2022-03-17 A stainless steel band that is used to form a mould around a tooth for the insertion of restorative materials.
• 00850015110627 - TEMREX MATRIX RETAINER: 2022-03-17 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 BAND: 2022-03-17 A stainless steel band that is used to form a mould around a tooth for the insertion of restorative materials.