ProTech Soft Reline LRH13

GUDID D814LRH131

1/2 Liter ProTech Soft Reline Heat Cure Monomer

PROTECH PROFESSIONAL PRODUCTS INC

Denture reliner, elastic, short-term

• Primary Device ID: D814LRH131
• NIH Device Record Key: 06990565-a200-481f-964b-a676903010a3
• Commercial Distribution Discontinuation: 2017-04-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ProTech Soft Reline
• Version Model Number: LRH13
• Catalog Number: LRH13
• Company DUNS: 117374900
• Company Name: PROTECH PROFESSIONAL PRODUCTS INC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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
HIBCC	D814LRH131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151646

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-20
• Device Publish Date: 2016-08-30

On-Brand Devices [ProTech Soft Reline ]

• D814SRHP5PV1: 2.25 kg ProTech Soft Reline Heat Cure Powder Shade Pink Veined
• D814SRHP5C1: 2.25 kg ProTech Soft Reline Heat Cure Powder Shade Clear
• D814SRHP3PV1: 440 gram ProTech Soft Reline Heat Cure Powder Shade Pink Veined
• D814SRHP3C1: 440 gram ProTech Soft Reline Heat Cure Powder Shade Clear
• D814SRHP2PV1: 220 gram ProTech Soft Reline Heat Cure Powder Shade Pink Veined
• D814SRHP2C1: 220 gram ProTech Soft Reline Heat Cure Powder Shade Clear
• D814SRHP1PV1: 110 gram ProTech Soft Reline Heat Cure Powder Shade Pink Veined
• D814SRHP1C1: 110 gram ProTech Soft Reline Heat Cure Powder Shade Clear
• D814SRH13PV1: 32 unit ProTech Soft Reline Kit Shade Pink Veined - 440 gram powder, 240 ml monomer, 15 ml super
• D814SRH13C1: 32 Unit ProTech Soft Reline Heat Cure Kit Shade Clear - 440 gram powder, 240 ml monomer and 15 m
• D814SRH12PV1: 16 unit ProTech Soft Reline Heat Cure Kit Shade Pink Veined - 220 gram powder, 120 ml monomer an
• D814SRH12C1: 16 unit ProTech Soft Reline Heat Cure Kit Shade Clear - 220 gram powder, 120 ml monomer and 15 m
• D814SRH11PV1: 8 unit ProTech Soft Reline Heat Cure Kit Shade Pink Veined - 110 gram powder, 60 ml monomer and
• D814SRH11C1: 8 unit ProTech Soft Reline Kit Shade Clear - include 60 ml Heat Cure Monomer, 110 gram Heat Cure
• D814SRCP5PV1: 2.25 kg ProTech Soft Reline Self Cure Powder Shade Pink Veined
• D814SRCP5C1: 2.25 kg ProTech Soft Reline Self Cure Powder Shade Clear
• D814SRCP3PV1: 440 gram ProTech Soft Reline Self Cure Powder Shade Pink Veined
• D814SRCP3C1: 440 gram ProTech Soft Reline Self Cure Powder Shade Clear
• D814SRCP2PV1: 220 gram ProTech Soft Reline Self Cure Powder Shade Pink Veined
• D814SRCP2C1: 220 gram ProTech Soft Reline Self Cure Powder Shade Clear
• D814SRCP1PV1: 110 gram ProTech Soft Reline Self Cure Shade Pink Veined
• D814SRCP1C1: 110 gram ProTech Soft Reline Self Cure Powder Shade Clear
• D814SRC13PV1: 32 unit ProTech Soft Reline Self Cure Kit Shade Pink Veined. 440 gram powder and 240 ml monomer
• D814SRC13C1: 32 unit ProTech Soft Reline Self Cure Kit Shade Clear - 440 gram powder and 240 ml monomer
• D814SRC12PV1: 16 unit ProTech Soft Reline Self Cure Kit Shade Pink Veined - 220 gram powder, 120 ml monomer, 1
• D814SRC12C1: 16 unit ProTech Soft Reline Self Cure Kit Shade Clear - 220 gram powder, 120 ml monomer and 15 m
• D814SRC11PV1: 8 unit ProTech Soft Reline Self Cure Kit Shade Pink Veined - 110 gram powder, 60 ml monomer, 15
• D814SRC11C1: 8 unit ProTech Soft Reline Self Cure Kit Shade Clear - 110 gram powder, 60 ml monomer, 15 ml sup
• D814LRH141: 1 Liter ProTech Soft Reline Heat Cure Monomer
• D814LRH131: 1/2 Liter ProTech Soft Reline Heat Cure Monomer
• D814LRH121: 240 ml ProTech Soft Reline Heat Cure Monomer
• D814LRH111: 120 ml ProTech Soft Reline Heat Cure Monomer
• D814LRH101: 60 ml ProTech Soft Reline Heat Cure Monomer
• D814LRC141: 1 Liter ProTech Soft Reline Self Cure Monomer
• D814LRC131: 1/2 Liter ProTech Soft Reline Self Cure Monomer
• D814LRC121: 240 ml ProTech Soft Reline Self Cure Monomer
• D814LRC111: 120 ml ProTech Soft Reline Self Cure Monomer
• D814LRC101: 60 ml ProTech Soft Reline Self Cure Monomer