ProTech Plus Tooth Acrylic RUC11C2

GUDID D814RUC11C21

ProTech Plus Tooth Acrylic Kit 2 - 5 shades 25 grams each - shades 66,77,81,59, Dark Incisal

PROTECH PROFESSIONAL PRODUCTS INC

Denture reliner, elastic, short-term

• Primary Device ID: D814RUC11C21
• NIH Device Record Key: 0faa5f12-4994-41f3-8900-c20185c88bf9
• Commercial Distribution Discontinuation: 2017-03-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ProTech Plus Tooth Acrylic
• Version Model Number: RUC11C2
• Catalog Number: RUC11C2
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	D814RUC11C21 [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: 2016-08-26

On-Brand Devices [ProTech Plus Tooth Acrylic]

• D814RUCPOLB1: 440 gram ProTech Plus Tooth Acrylic Shade Pink Opaque
• D814RUCPOA11: 50 gram ProTech Plus Tooth Acrylic Shade Pink Opaque
• D814RUCPOA1: 110 gram ProTech Plus Tooth Acrylic Shade Pink Opaque
• D814RUCPO1: 25 gram ProTech Plus Tooth Acrylic Shade Pink Opaque
• D814RUCOWOLB1: 440 gram ProTech Plus Tooth Acrylic Shade Off White
• D814RUCOWOA11: 50 gram ProTech Plus Tooth Acrylic Shade Off white
• D814RUCOWA1: 110 gram ProTech Plus Tooth Acrylic Shade Off White
• D814RUCOW1: 25 gram ProTech Plus Tooth Acrylic Shade Off White
• D814RUCDILB1: 440 gram ProTech Plus Tooth Acrylic Shade Dark Incisal
• D814RUCDIA11: 50 gram ProTech Plus Tooth Acrylic Shade Dark Incisal
• D814RUCDIA1: 110 gram ProTech Plus Tooth Acrylic Shade Dark Incisal
• D814RUCDI1: 25 gram ProTech Plus Tooth Acrylic Shade Dark Incisal
• D814RUC87LB1: 440 gram ProTech Plus Tooth Acrylic Shade 87
• D814RUC87A11: 50 gram ProTech Plus Tooth Acrylic Shade 87
• D814RUC87A1: 110 gram ProTech Plus Tooth Acrylic Shade 87
• D814RUC871: 25 gram ProTech Plus Tooth Acrylic Shade 87
• D814RUC81LB1: 440 gram ProTech Plus Tooth Acrylic Shade 81
• D814RUC81A11: 50 gram ProTech Plus Tooth Acrylic Shade 81
• D814RUC81A1: 110 gram ProTech Plus Tooth Acrylic Shade 81
• D814RUC811: 25 gram ProTech Plus Tooth Acrylic Shade 81
• D814RUC77LB1: 440 gram ProTech Plus Tooth Acrylic Shade 77
• D814RUC77A11: 50 gram ProTech Plus Tooth Acrylic Shade 77
• D814RUC77A1: 110 gram ProTech Plus Tooth Acrylic Shade 77
• D814RUC771: 25 gram ProTech Plus Tooth Acrylic Shade 77
• D814RUC69LB1: 440 gram ProTech Plus Tooth Acrylic Shade 69
• D814RUC69A11: 50 gram ProTech Plus Tooth Acrylic Shade 69
• D814RUC69A1: 110 gram ProTech Plus Tooth Acrylic Shade 69
• D814RUC691: 25 gram ProTech Plus Tooth Acrylic Shade 69
• D814RUC67LB1: 440 gram ProTech Plus Tooth Acrylic Shade 67
• D814RUC67A11: 50 gram ProTech Plus Tooth Acrylic Shade 67
• D814RUC67A1: 110 gram ProTech Plus Tooth Acrylic Shade 67
• D814RUC671: 25 gram ProTech Plus Tooth Acrylic Shade 67
• D814RUC66LB1: 440 gram ProTech Plus Tooth Acrylic Shade 66
• D814RUC66A11: 50 grams ProTech Plus Tooth Acrylic Shade 66
• D814RUC66A1: 110 gram ProTech Plus Tooth Acrylic Shade 66
• D814RUC661: 25 grams ProTech Plus Tooth Acrylic Shade 66
• D814RUC65LB1: 440 gram ProTech Plus Tooth Acrylic Shade 65
• D814RUC65A11: 50 gram ProTech Plus Tooth Acrylic Shade 65
• D814RUC65A1: 110 gram ProTech Plus Tooth Acrylic Shade 65
• D814RUC651: 25 gram ProTech Plus Tooth Acrylic Shade 65
• D814RUC62LB1: 440 gram ProTech Plus Tooth Acrylic Shade 62
• D814RUC62A11: 50 gram ProTech Plus Tooth Acrylic Shade 62
• D814RUC62A1: 110 gram ProTech Plus Tooth Acrylic Shade 62
• D814RUC621: 25 gram ProTech Plus Tooth Acrylic Shade 62
• D814RUC59LB1: 440 gram ProTech Plus Tooth Acrylic Shade 59
• D814RUC59A11: 50 gram ProTech Plus Tooth Acrylic Shade 59
• D814RUC59A1: 110 gram ProTech Plus Tooth Acrylic Shade 59
• D814RUC595LB1: 2.25 kg ProTech Plus Tooth Acrylic Shade 59
• D814RUC591: 25 grams of ProTech Plus Tooth Acrylic Shade 59
• D814RUC11C21: ProTech Plus Tooth Acrylic Kit 2 - 5 shades 25 grams each - shades 66,77,81,59, Dark Incisal