ULTRAFLEX PUFMCDARKEK1

GUDID D810PUFMCDARKEK11

DENTURE MATERIAL - ECONO KIT - PACKAGE 320 GRAMS POWDER/ 240 GRAMS LIQUID

ASTRON DENTAL CORPORATION

Custom-made mouthguard

• Primary Device ID: D810PUFMCDARKEK11
• NIH Device Record Key: fcf5356d-a724-4fae-af52-e026fada7461
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRAFLEX
• Version Model Number: PUFMCDARKEK1
• Catalog Number: PUFMCDARKEK1
• Company DUNS: 056624901
• Company Name: ASTRON DENTAL CORPORATION
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 847-726-8787
• Email: ASTRONCORP@AOL.COM
• Phone: 847-726-8787
• Email: ASTRONCORP@AOL.COM

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D810PUFMCDARKEK11 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K874025

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: 2018-09-24
• Device Publish Date: 2016-09-07

On-Brand Devices [ULTRAFLEX]

• D810PUFMCSEK11: DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/ 3 EACH 240 GRAMS LIQUID
• D810PUFMCLK1: DENTURE MATERIAL - LAB KIT - PACKAGE 160 GRAMS POWDER/ 120 GRAMS LIQUID
• D810PUFMCEK11: DENTURE MATERIAL - ECONO KIT - PACKAGE 320 GRAMS POWDER/ 240 GRAMS LIQUID
• D810PUFMCDARKSEK11: DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/ 3 EACH 240 GRAMS LIQUID
• D810PUFMCDARKLK11: DENTURE MATERIAL -LAB KIT - PACKAGE 160 GRAMS POWDER/ 120 GRAMS LIQUID
• D810PUFMCDARKEK11: DENTURE MATERIAL - ECONO KIT - PACKAGE 320 GRAMS POWDER/ 240 GRAMS LIQUID
• D810PUFELSEK11: DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/ 3 EACH 240 GRAMS LIQUID
• D810PUFELLK11: DENTURE MATERIAL - LAB KIT - PACKAGE 160 GRAMS POWDER/120 GRAMS LIQUID
• D810PUFELEK11: DENTURE MATERIAL - ECONO KIT - PACKAGE 320 GRAMS POWDER/ 240 GRAMS LIQUID
• D810PUFDFPFSEK11: DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/ 3 EACH 240 GRAMS LIQUID
• D810PUFDFPFLK11: DENTURE MATERIAL - LAB KIT - PACKAGE 160 GRAMS POWDER/120 GRAMS LIQUID
• D810PUFDFPFEK11: DENTURE MATERIAL - ECONO KIT - PACKAGE 320 GRAMS POWDER / 240 GRAMS LIQUID
• D810PUFCLRSEK11: DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/ 3 EACH 240 GRAMS LIQUID
• D810PUFCLRLK11: DENTURE MATERIAL - LAB KIT - PACKAGE 160 GRAMS POWDER/120 GRAMS LIQUID
• D810PUFCLREK11: DENTURE MATERIAL - ECONO KIT - PACKAGE 320 GRAMS POWDER/ 240 GRAMS LIQUID
• D810PUF99SEK11: DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/ 3 EACH 240 GRAMS LIQUID
• D810PUF99LK11: DENTURE MATERIAL - LAB KIT - PACKAGE 160 GRAMS POWDER/120 GRAMS LIQUID
• D810PUF99EK11: DENTURE MATERIAL - ECONO KIT - PACKAGE 320 GRAMS POWDER/ 240 GRAMS LIQUID