American Eagle Instruments

Basic Information

• Brand Name: American Eagle Instruments
• Primary DI: 00841013120411
• Version / Model: AEASPBASK1
• Catalog Number: AEASPBASK1
• Company Name: AMERICAN EAGLE INSTRUMENTS, INC.
• Labeler DUNS: 790776850
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-15
• Public Version: 1
• Public Version Date: 2024-11-25
• Public Version Status: New
• Public Device Record Key: cfebc89f-83be-441f-85d0-4509060f1403

Device Description

Aspen Dental Basic Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
DZN	INSTRUMENTS, DENTAL HAND	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35320	Manual dental scaler, reusable	A hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841013120411	GS1

Customer Contacts

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