Hard Inlay Wax (ivory chunks)

Basic Information

• Brand Name: Hard Inlay Wax (ivory chunks)
• Primary DI: 10697660004584
• Version / Model: 5312-1
• Company Name: Oculo-Plastik Inc
• Labeler DUNS: 257382580
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-28
• Public Version: 2
• Public Version Date: 2022-03-25
• Public Version Status: Update
• Public Device Record Key: 925ae1b5-14b2-46f4-8f13-ca7661d57c74
• Distribution End Date: 2022-03-24

Device Description

Hard Inlay Wax (ivory chunks)

Device Characteristics

• Single Use: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EGD	Wax, Dental, Intraoral	Dental	872.6890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34807	Wax dental impression material	A material made of wax, sometimes in combination with resins of low melting point, designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10697660004584	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	1	Pound
Weight	454	Gram