Eagle Spectrum

Basic Information

• Brand Name: Eagle Spectrum
• Primary DI: 00190746007705
• Version / Model: 001-940
• Catalog Number: 001-940
• Company Name: AMERICAN ORTHODONTICS CORPORATION
• Labeler DUNS: 044668515
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-09
• Public Version: 4
• Public Version Date: 2020-07-23
• Public Version Status: Update
• Public Device Record Key: be6fdc02-247e-411d-97b6-a678fe4960c3

Device Description

EAGLE SPECTRUM LIGHT CURE SYRINGE KIT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
DYH	ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN	Dental	872.3750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31750	Orthodontic bracket adhesive	A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190746007705	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K831495	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away from Light
• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius