Articulating paper/film

Basic Information

• Brand Name: Articulating paper/film
• Primary DI: D04060203225
• Version / Model: 60203
• Catalog Number: 60203
• Company Name: WHIP-MIX CORPORATION
• Labeler DUNS: 006385173
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-24
• Public Version: 2
• Public Version Date: 2022-02-21
• Public Version Status: Update
• Public Device Record Key: 58e16f1f-c1d9-41e4-b6ce-6546f6ad1e1d
• Distribution End Date: 2022-02-18

Device Description

A strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device.

Device Characteristics

• Single Use: Yes
• 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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFH	Paper, Articulation	Dental	872.6140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16181	Dental articulation paper	A strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D04060203225	HIBCC