DENALI

Basic Information

• Brand Name: DENALI
• Primary DI: 00810042120426
• Version / Model: 681A-17B
• Company Name: ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC
• Labeler DUNS: 077801124
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-21
• Public Version: 1
• Public Version Date: 2020-04-29
• Public Version Status: New
• Public Device Record Key: 6e928bff-c750-43a6-9989-0d01840c0020

Device Description

Dontrix Force Gauge

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: 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
EIL	Gauge, Depth, Instrument, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44861	Orthodontic appliance force gauge	A hand-held dental instrument intended to be used in orthodontics to accurately measure forces (in grams or ounces) applied by the elastics or springs used when setting up orthodontic appliances within the patient's mouth. The device is typically of cylindrical or tubular design (but can be dial-shaped with circular read out) and is made of metal (some partly plastic); it contains a spring-loaded mechanism which indicates the force exerted to pull the appliance elastic or spring to the desired length. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810042120426	GS1