D5A Fully-Adjustable Articulator

Basic Information

• Brand Name: D5A Fully-Adjustable Articulator
• Primary DI: D04011026011
• Version / Model: 110230-1
• Catalog Number: 110260-1
• Company Name: WHIP-MIX CORPORATION
• Labeler DUNS: 006385173
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-22
• Public Version: 1
• Public Version Date: 2020-09-30
• Public Version Status: New
• Public Device Record Key: 8d5e706a-55a7-46be-af81-f2e55e949ff9

Device Description

A dental articulator is a device designed to simulate all or part of the mandibular movements and used for examination, diagnosis, or to construct dental appliances. This is a reusable device.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJP	Articulators	Dental	872.3150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10201	Dental articulator	A hinged, mechanical, dental device designed to simulate the movement of a patient's upper and lower jaws and onto which maxillary and mandibular casts or models are attached according to a pre-recorded intermaxillary relationship. It is designed to simulate all or part of the mandibular movements and is used for, e.g., examination, diagnosis, or to construct dental appliances. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D04011026011	HIBCC