PRESIDENT The Original

Basic Information

• Brand Name: PRESIDENT The Original
• Primary DI: 07640181479665
• Version / Model: 60019945
• Catalog Number: 60019945
• Company Name: Coltène/Whaledent AG
• Labeler DUNS: 480017482
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-11
• Public Version: 1
• Public Version Date: 2022-02-21
• Public Version Status: New
• Public Device Record Key: 86611143-037a-4e28-a743-3b72d2300c43

Device Description

PRESIDENT The Original MonoBody System 360 Starter Kit, 1 x 380 ml

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: 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
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	07640181479665	GS1

Premarket Submissions

Submission Number	Supplement Number
K220097	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 23 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight