KöR

Basic Information

• Brand Name: KöR
• Primary DI: 00850362007144
• Version / Model: KöR Suction Tip
• Catalog Number: 80-1029
• Company Name: EVOLVE DENTAL TECHNOLOGIES, INC.
• Labeler DUNS: 005479970
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-31
• Public Version: 1
• Public Version Date: 2021-04-08
• Public Version Status: New
• Public Device Record Key: a3111ba1-2541-4447-9efd-20f274c1a1eb

Device Description

Dental Suction Tip

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: No
• 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
DYN	Mouthpiece, Saliva Ejector	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63670	Intraoral dental suction tip holder	A non-sterile semi-flexible device intended to be attached to the distal end of a dental suction tip and held between the teeth and cheek of a patient, to allow for hands-free suction during a dental procedure. It is typically a flat disk made of synthetic polymer materials with a clip/loop for attachment to the suction tip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850362007144	GS1