CLEARSPLINT

Basic Information

• Brand Name: CLEARSPLINT
• Primary DI: D810PCSD2598BES111
• Version / Model: PCSD2598BES1
• Catalog Number: PCSD2598BES1
• Company Name: ASTRON DENTAL CORPORATION
• Labeler DUNS: 056624901
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-27
• Public Version: 1
• Public Version Date: 2023-02-06
• Public Version Status: New
• Public Device Record Key: acb7ea50-3b37-4dae-b043-f9284d57c738

Device Description

Clearsplint Disc 98mm x 25mm Shoulder Clear BES 1 Unit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQC	Mouthguard, Prescription	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
46492	Mouthguard, single-use	A prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during surgery or intubation. It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D810PCSD2598BES111	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K111828	000