Dentorium AC520A

GUDID 05056079040534

Heat Cure Denture Base Liquid

WRIGHT HEALTH GROUP LIMITED

Denture base resin kit

• Primary Device ID: 05056079040534
• NIH Device Record Key: 732eef2e-2cce-4153-8b42-8468eee29770
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dentorium
• Version Model Number: Dentorium Monomer Std Heat Cure 8 Oz
• Catalog Number: AC520A
• Company DUNS: 214045304
• Company Name: WRIGHT HEALTH GROUP LIMITED
• 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: 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

Customer Support Contacts

• Phone: +1(800)847-4209
• Email: mail@dentorium.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056079040534 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011820

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-01

On-Brand Devices [Dentorium]

• 05056079042200: Base Plates / Special Impression Tray Blanks. Shellac resin. Double thickness. Green. Lower.
• 05056079042194: Base Plates / Special Impression Tray Blanks. Shellac resin. Double thickness. Green. Upper.
• 05056079042187: Base Plates / Special Impression Tray Blanks. Shellac resin. Double thickness. Green. Lower.
• 05056079042170: Base Plates / Special Impression Tray Blanks. Shellac resin. Double thickness. Green. Upper.
• 05056079042163: Base Plates / Special Impression Tray Blanks. Shellac resin. Single thickness. Pink. Lower.
• 05056079042156: Base Plates / Special Impression Tray Blanks. Shellac resin. Single thickness. Pink. Upper.
• 05056079042149: Base Plates / Special Impression Tray Blanks. Shellac resin. Single thickness. Pink. Lower.
• 05056079042132: Base Plates / Special Impression Tray Blanks. Shellac resin. Single thickness. Pink. Upper.
• 05056079041531: Cold Cure Denture Base Powder
• 05056079041524: Cold Cure Denture Base Powder
• 05056079041517: Cold Cure Denture Base Powder
• 05056079041500: Cold Cure Denture Base Powder
• 05056079041494: Cold Cure Denture Base Powder
• 05056079041487: Cold Cure Denture Base Powder
• 05056079041470: Cold Cure Denture Base Powder
• 05056079041463: Cold Cure Denture Base Powder
• 05056079041456: Cold Cure Denture Base Powder
• 05056079041449: Cold Cure Denture Base Powder
• 05056079041432: Cold Cure Denture Base Powder
• 05056079041425: Cold Cure Denture Base Powder
• 05056079041418: Cold Cure Denture Base Powder
• 05056079041401: Cold Cure Denture Base Powder
• 05056079041395: Cold Cure Denture Base Powder
• 05056079041388: Cold Cure Denture Base Powder
• 05056079041371: Cold Cure Denture Base Powder
• 05056079041364: Cold Cure Denture Base Powder
• 05056079041357: Heat Cure Denture Base Powder
• 05056079041340: Heat Cure Denture Base Powder
• 05056079041333: Heat Cure Denture Base Powder
• 05056079041326: Heat Cure Denture Base Powder
• 05056079041319: Heat Cure Denture Base Powder
• 05056079041302: Heat Cure Denture Base Powder
• 05056079041296: Heat Cure Denture Base Powder
• 05056079041289: Heat Cure Denture Base Powder
• 05056079041272: Heat Cure Denture Base Powder
• 05056079041265: Heat Cure Denture Base Powder
• 05056079041258: Heat Cure Denture Base Powder
• 05056079041241: Heat Cure Denture Base Powder
• 05056079041234: Heat Cure Denture Base Powder
• 05056079041227: Heat Cure Denture Base Powder
• 05056079041210: Heat Cure Denture Base Powder
• 05056079041203: Heat Cure Denture Base Powder
• 05056079041197: Heat Cure Denture Base Powder
• 05056079041180: Heat Cure Denture Base Powder
• 05056079041173: Heat Cure Denture Base Powder
• 05056079041166: Heat Cure Denture Base Powder
• 05056079041159: Heat Cure Denture Base Powder
• 05056079041142: Heat Cure Denture Base Powder
• 05056079041135: Heat Cure Denture Base Powder
• 05056079041128: Heat Cure Denture Base Powder