EMULATE

Basic Information

• Brand Name: EMULATE
• Primary DI: D74439047690
• Version / Model: 3904-769
• Company Name: BENCO DENTAL SUPPLY CO.
• Labeler DUNS: 015108087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-02
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4e72a65b-83a3-44de-a170-8946a05c1dcc

Device Description

Emulate Advanced Alginate Fast Set Case of 8 Pouches

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: No
• Has Serial Number: No
• 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
35863	Alginate dental impression material	A material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is 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	D74439047690	HIBCC
Package	D74439047691	HIBCC	CASE	8	In Commercial Distribution

Device Sizes

Type	Value	Unit	Text
Weight	500	Gram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius