Honigum Trial Kit

Basic Information

• Brand Name: Honigum Trial Kit
• Primary DI: EDMG9995001
• Version / Model: 999500
• Catalog Number: 999500
• Company Name: DMG Chemisch-Pharmazeutische Fabrik GmbH
• Labeler DUNS: 320744915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e0313aac-ce34-4163-aed3-dd00f6e6680b

Device Description

VPS-based impression material, Heavy-bodied and light-bodied consistency. Professional precision. Content: 2 cartridges Honigum Heavy @ 50 ml paste, 1 cartridge Honigum Light @ 50 ml paste, Accessories

Device Characteristics

• Single Use: No
• 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: Yes
• 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
ELW	Material, Impression	Dental	872.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35866	Silicone dental impression material	An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable 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	EDMG9995001	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K000878	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Protect against exposure to direct sunlight!
• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit