LABTEC PLTDFPFSEK1

GUDID D810PLTDFPFSEK11

DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/ 3 EACH 240 GRAMS LIQUID

ASTRON DENTAL CORPORATION

Custom-made mouthguard

• Primary Device ID: D810PLTDFPFSEK11
• NIH Device Record Key: 5310d6dc-90f9-4f8f-8b6a-b0425503b8f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LABTEC
• Version Model Number: PLTDFPFSEK1
• Catalog Number: PLTDFPFSEK1
• 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	D810PLTDFPFSEK11 [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 [LABTEC]

• D810PLTELSEK11: DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/ 3 EACH 240 GRAMS LIQUID
• D810PLTELEK11: DENTURE MATERIAL - ECONO KIT - PACKAGE 320 GRAMS POWDER/ 240 GRAMS LIQUID
• D810PLTDFPFSEK11: DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/ 3 EACH 240 GRAMS LIQUID
• D810PLTDFPFEK11: DENTURE MATERIAL - ECONO KIT - PACKAGE 320 GRAMS POWDER/ 240 GRAMS LIQUID
• D810PLTCLRSEK11: DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/ 3 EACH 240 GRAMS LIQUID
• D810PLTCLREK11: DENTURE MATERIAL - ECONO KIT - PACKAGE 320 GRAMS POWDER/ 240 GRAMS LIQUID
• D810PLT99SEK11: DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/ 3 EACH 240 GRAMS LIQUID
• D810PLT99EK11: DENTURE MATERIAL - ECONO KIT - PACKAGE 320 GRAMS POWDER/240 GRAMS LIQUID