The Original Clearsplint Disc PCSD16

GUDID D810PCSD1698111

Package of 1 disc 98mmX16mm with shoulder

ASTRON DENTAL CORPORATION

Mouthguard, single-use Mouthguard, single-use Mouthguard, single-use Mouthguard, single-use Mouthguard, single-use

• Primary Device ID: D810PCSD1698111
• NIH Device Record Key: 7980d787-377f-44ee-b9b7-6b1d358e5d7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Original Clearsplint Disc
• Version Model Number: PCSD16
• Catalog Number: PCSD16
• 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: false
• Device Combination Product: false
• Single Use: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 847-726-8787
• Email: doug@astrondental.com
• Phone: 847-726-8787
• Email: doug@astrondental.com
• Phone: 847-726-8787
• Email: doug@astrondental.com
• Phone: 847-726-8787
• Email: doug@astrondental.com
• Phone: 847-726-8787
• Email: doug@astrondental.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D810PCSD1698111 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-26
• Device Publish Date: 2021-07-16

On-Brand Devices [The Original Clearsplint Disc]

• D810PCSD985111: Package of 1 disc 98mmX20mm with shoulder
• D810PCSD2098NS111: Package of 1 disc 98mmX20mm with no shoulder
• D810PCSD2095Z111: Package of 1 disc 95mmX20mm Zirkonzahn/Clover Leaf Edge
• D810PCSD1698111: Package of 1 disc 98mmX16mm with shoulder