KöR

Basic Information

• Brand Name: KöR
• Primary DI: 00850362007052
• Version / Model: KöR Desensitizer-10ml
• Catalog Number: 10-1010
• Company Name: EVOLVE DENTAL TECHNOLOGIES, INC.
• Labeler DUNS: 005479970
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-23
• Public Version: 4
• Public Version Date: 2019-02-07
• Public Version Status: Update
• Public Device Record Key: 5626a3b9-c33e-4e0c-b95a-397e69a27490

Device Description

KöR Desensitizer-10ml

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
KLE	Agent, Tooth Bonding, Resin	Dental	872.3200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45232	Dental coating, tooth-desensitizing	A substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850362007052	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K953405	000

Device Sizes

Type	Value	Unit	Text
Total Volume	10	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not store above 77°F (25°C). Refrigeration is recommended if not used for a long period of time. Allow to return to room temperature prior to use. DO NOT FREEZE.