CLEARSPLINT PCSFLK1

GUDID D810PCSFLK11

DENTURE MATERIAL - PACKAGE 160 GRAMS POWDER/120 GRAMS LIQUID

ASTRON DENTAL CORPORATION

Custom-made mouthguard

• Primary Device ID: D810PCSFLK11
• NIH Device Record Key: 05f8b2f8-7a25-4d47-8ad5-b95c5fd2ec34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARSPLINT
• Version Model Number: PCSFLK1
• Catalog Number: PCSFLK1
• 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	D810PCSFLK11 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111828

FDA Product Code

• MQC: Mouthguard, Prescription

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 [CLEARSPLINT]

• D810PCSRSEK11: DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/3 EACH 240 GRAMS LIQUID
• D810PCSRLK11: DENTURE MATERIAL - PACKAGE 160 GRAMS POWDER/120 GRAMS LIQUID
• D810PCSREK11: DENTURE MATERIAL - PACKAGE 320 GRAMS POWDER / 240 GRAMS LIQUID
• D810PCSFSEK11: DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/ 3 EACH 240 GRAMS LIQUID
• D810PCSFLK11: DENTURE MATERIAL - PACKAGE 160 GRAMS POWDER/120 GRAMS LIQUID
• D810PCSFEK11: DENTURE MATERIAL - PACKAGE 320 GRAMS POWDER / 240 GRAMS LIQUID