Astek

Basic Information

• Brand Name: Astek
• Primary DI: 05060111781989
• Version / Model: 21008PKD
• Catalog Number: 21008PKD
• 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: 3
• Public Version Date: 2023-05-12
• Public Version Status: Update
• Public Device Record Key: b7b719f1-8cef-4bd8-9779-9840296d5567
• Distribution End Date: 2023-05-12

Device Description

Alma Bite Plane

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIL	GAUGE, DEPTH, INSTRUMENT, DENTAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31846	Dental implantation depth/angle gauge, reusable	A device designed to be used during the planning and post-osteotomy stages of a dental implantation procedure, prior to surgical implant placement/fixation, to measure/determine various lengths (e.g., drill depth of the osteotomy cavity, mucosal height, distance between implants/teeth for determining the mesiodistal position of the implant) and/or angles [e.g., direction of the perforation in relation to the antagonist arch], typically to help select an appropriate final prosthetic abutment to be installed. It is typically graduated and may be a hand-held instrument or a stand-alone device placed intraorally; some types are intended for use during x-ray imaging. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15060111781986	GS1	Package	1	Not in Commercial Distribution	2023-05-12
Primary	05060111781989	GS1

Customer Contacts

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