ProTech Plus Hard Reline and Repair Acrylic PLUS13F

GUDID D814PLUS13F0

ProTech Plus 1/2 Liter Monomer

PROTECH PROFESSIONAL PRODUCTS INC

Denture reliner, elastic, short-term

• Primary Device ID: D814PLUS13F0
• NIH Device Record Key: 0466f6d8-02f1-4185-9711-3bc59cbe481a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProTech Plus Hard Reline and Repair Acrylic
• Version Model Number: PLUS13F
• Catalog Number: PLUS13F
• 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	D814PLUS13F0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131036

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-28
• Device Publish Date: 2019-05-20

On-Brand Devices [ProTech Plus Hard Reline and Repair Acrylic]

• D814PLU15GL1: 4.5 kg ProTech Plus hard Reline and Repair Acrylic Shade Clear
• D814PLU15GD1: 4.5 kg ProTech Plus Hard Reline and Repair Acrylic Shade 506RR
• D814PLU15GC1: 4.5 kg ProTech Plus Hard Reline and Repair Acrylic Shade 1060LL
• D814PLU15GA1: 4.5 kg ProTech Plus Hard Reline and Repair Acrylic Shade 1069LO
• D814PLU15G1: 11.25 kg ProTech Plus Hard Reline and Repair Acrylic Shade JP
• D814PLU15F1: 4 Liter ProTech Plus Hard Reline and Repair Acrylic Monomer
• D814PLU14GL1: 4.5 kg ProTech Plus Hard Reline and Repair Acrylic Shade Clear
• D814PLU14GD1: 4.5 kg ProTech Plus Hard Reline and Repair Acrylic Shade 506RR
• D814PLU14GC1: 4.5 kg ProTech Plus Hard Reline and Repair Acrylic Shade 1060LL
• D814PLU14GA1: 4.5 kg ProTech Plue Hard Reline and Repair Acrylic Shade 1069LO
• D814PLU14G1: 4.5 kg ProTech Plus Hard Reline and Repair Acrylic Shade JP
• D814PLU14F1: 1 Liter ProTech Plus Hard Reline and Repair Acrylic Monomer
• D814PLU13GL1: 2.25 kg ProTech Plus Hard Reline and Repair Acrylic Shade Clear
• D814PLU13GD1: 2.25 kg ProTech Plus Hard Reline and Repair Acrylic Shade 506RR
• D814PLU13GC1: 2.25 kg ProTech Plus Hard Reline and Repair Acrylic Shade 1060LL
• D814PLU13GA1: 2.25 kg ProTech Plus Hard Reline and Repair Acrylic Shade 1069LO
• D814PLU13G1: 2.25 kg ProTech Plus Hard Reline and Repair Acrylic Shade JP
• D814PLU13F1: 1/2 Liter ProTech Plus Hard Reline and Repair Acrylic Monomer
• D814PLU12L1: ProTech Plus Hard Reline and Repair Acrylic Kit - 440 gram powder shade Clear and 240 ml Monomer
• D814PLU12GL1: 440 gram ProTech Plus Hard Reline and Repair Acrylic Shade Clear
• D814PLU12GD1: 440 gram ProTech Plus Hard Reline and Repair Acrylic Shade 506RR
• D814PLU12GC1: 440 gram ProTech Plus Hard Reline and Repair Acrylic Shade 1060LL
• D814PLU12GA1: 440 gram ProTech Plus Hard Reline and Repair Acrylic Shade 1069LO
• D814PLU12G1: 440 gram ProTech Plus Hard Reline and Repair Acrylic Shade JP
• D814PLU12F1: 240 ml ProTech Plus Hard Reline and Repair Acrylic Monomer
• D814PLU12D1: ProTech Plus Hard Reline and Repair Acrylic Kit - 440 gram powder Shade 506RR and 240 ml monomer
• D814PLU12C1: ProTech Plus Hard Reline and Repair Acrylic Kit - 440 gram powder Shade 1060LL and 240 ml Monome
• D814PLU12A1: ProTech Plus Hard Reline and Repair Acrylic Kit - 440 gram powder shade 1069LO and 240 ml Monome
• D814PLU121: ProTech Plus Hard Reline and Repair Acrylic Kit - 440 gram JP powder and 240 ml monomer
• D814PLUS14GL0: 4.5 kg ProTech Plus Powder Only Shade Clear
• D814PLUS14GA0: 4.5 kg ProTech Plus powder only Shade 1069LO
• D814PLUS14G0: 4.5 kg ProTech Plus Powder Only Shade JP
• D814PLUS14F0: ProTech Plus Liter Monomer
• D814PLUS13GL0: ProTech Plus 2.25 kg Powder only Shade Clear
• D814PLUS13GA0: 2.25 kg ProTech Plus Powder only Shade 1069LO
• D814PLUS13G0: 2.25 kg ProTech Plus Powder Only shade JP
• D814PLUS13F0: ProTech Plus 1/2 Liter Monomer
• D814PLUS12L0: ProTech Plus Kit Shade Clear - 440 g ProTech Plus Powder and 240 ml ProTech Plus Monomer
• D814PLUS12GL0: ProTech Plus 440 gram Powder only Shade Clear
• D814PLUS12GA0: ProTech Plus 440 g Powder Only Shade 1069LO
• D814PLUS12G0: 440 Gram ProTech Plus Powder Only Shade JP
• D814PLUS12F0: 240 ml ProTech Plus Monomer
• D814PLUS12A0: ProTech Plus Kit Shade 1069LO - 440 g ProTech Plus Powder and 240 ml ProTech Plus Monomer
• D814PLUS120: ProTech Plus Kit Shade JP - 440 g ProTech Plus Powder and 240 ml ProTech Plus Monomer
• D814PLUS13GD0: ProTech Plus Shade 506RR 2.25 kg Powder Only
• D814PLUS13GC0: ProTech Plus Shade 1060LL 2.25 kg Powder Only
• D814PLUS12GD0: ProTech Plus Shade 506RR 440 g Powder Only
• D814PLUS12GC0: ProTech Plus Shade 1060LL 440 gram Powder Only
• D814PLUS12AD0: ProTech Plus Kit Shade 506RR - 440 g ProTech Plus Powder and 240 ml ProTech Plus Monomer
• D814PLUS12AC0: ProTech Plus Kit Shade 1060LL - 440 g ProTech Plus Powder and 240 ml ProTech Plus Monomer