Astek

Basic Information

• Brand Name: Astek
• Primary DI: 00843471152850
• Version / Model: 19024
• Catalog Number: 19024
• Company Name: Young Innovations, Inc.
• Labeler DUNS: 004193103
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-18
• Public Version: 2
• Public Version Date: 2023-02-06
• Public Version Status: Update
• Public Device Record Key: fee368ce-6c2a-4d0d-983e-4240dc4b8aa5
• Distribution End Date: 2023-02-03

Device Description

Pro Matrix sample Pack (2 x Wide Curved)

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
JEP	RETAINER, MATRIX	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45008	Dental matrix band tensioner	A hand-held, dental instrument designed for tightening a matrix band around a tooth that is being prepared for a dental restoration. It is a rod-like device, typically designed with a manually controlled rotating action at its distal end for insertion into and tightening of a retainerless matrix band around the tooth. When the matrix band is in place, this device is removed offering a clear field of vision. Some types may incorporate a torque control mechanism to limit over-tensioning. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10843471152857	GS1	Package	2	Not in Commercial Distribution	2023-02-03
Primary	00843471152850	GS1
Package	20843471152854	GS1	Case	50	Not in Commercial Distribution	2023-02-03

Customer Contacts

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