ASTRON 1180 1180EC1

GUDID D8101180EC11

DENTURE MATERIAL - 10 UNIT KIT - 10 EACH 25 GRAM UNITS

ASTRON DENTAL CORPORATION

Custom-made mouthguard

• Primary Device ID: D8101180EC11
• NIH Device Record Key: 8ec45dbe-e50a-4eeb-973d-636059bcfbbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASTRON 1180
• Version Model Number: 1180EC1
• Catalog Number: 1180EC1
• 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	D8101180EC11 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K833270

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 [ASTRON 1180]

• D8101180MFT11: DENTURE MATERIAL - 10 UNIT KIT - 10 EACH 25 GRAM UNITS
• D8101180LFT11: DENTURE MATERIAL - 10 UNIT KIT - 10 each 25 gram units
• D8101180EC11: DENTURE MATERIAL - 10 UNIT KIT - 10 EACH 25 GRAM UNITS