ProTech RAL12

GUDID D814RAL121

ProTech Self Cure Acrylic Repair Monomer

PROTECH PROFESSIONAL PRODUCTS INC

Denture reliner, elastic, short-term

• Primary Device ID: D814RAL121
• NIH Device Record Key: 37a415a2-6bf8-4e93-b88d-600b117e9bea
• Commercial Distribution Discontinuation: 2016-11-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ProTech
• Version Model Number: RAL12
• Catalog Number: RAL12
• 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	D814RAL121 [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: 2019-05-17
• Device Publish Date: 2016-11-01

Devices Manufactured by PROTECH PROFESSIONAL PRODUCTS INC

• D814UBARV11AD0 - ProTech UBAR: 2019-11-07 UBAR Value Kit Shade 506RR - 160 gram powder, 200 ml monomer, 14 ml bonding liner
• D814UBARV11GD0 - ProTech UBAR: 2019-11-07 ProTech UBAR Powder Shade 506RR 160 g
• D814PLUS12AC0 - ProTech Plus Hard Reline and Repair Acrylic: 2019-10-02 ProTech Plus Kit Shade 1060LL - 440 g ProTech Plus Powder and 240 ml ProTech Plus Monomer
• D814PLUS12AD0 - ProTech Plus Hard Reline and Repair Acrylic: 2019-10-02 ProTech Plus Kit Shade 506RR - 440 g ProTech Plus Powder and 240 ml ProTech Plus Monomer
• D814PLUS12GC0 - ProTech Plus Hard Reline and Repair Acrylic: 2019-10-02 ProTech Plus Shade 1060LL 440 gram Powder Only
• D814PLUS12GD0 - ProTech Plus Hard Reline and Repair Acrylic: 2019-10-02 ProTech Plus Shade 506RR 440 g Powder Only
• D814PLUS13GC0 - ProTech Plus Hard Reline and Repair Acrylic: 2019-10-02 ProTech Plus Shade 1060LL 2.25 kg Powder Only
• D814PLUS13GD0 - ProTech Plus Hard Reline and Repair Acrylic: 2019-10-02 ProTech Plus Shade 506RR 2.25 kg Powder Only