Roydent

Basic Information

• Brand Name: Roydent
• Primary DI: D8091031
• Version / Model: 103
• Catalog Number: 103
• Company Name: ROYDENT DENTAL PRODUCTS INC
• Labeler DUNS: 131487225
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-10-07
• Public Version: 3
• Public Version Date: 2019-07-12
• Public Version Status: Update
• Public Device Record Key: f6e6136c-7431-4e10-9af8-56ba7f288898

Device Description

C.L. CANAL LUBRICANT (20 COUNT

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
EKL	POINT, SILVER, ENDODONTIC	Dental	872.3840	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45480	Dental root surface conditioner	A dental material, typically of neutral pH, used for topical application on exposed/scaled root surfaces for the removal of the smear layer (adherent debris produced when cutting the enamel or dentin in cavity or endodontic preparation, Circa 1 micron thick) during dental/periodontal surgery. The material is removed (washed off) after the recommended period to expose the collagenous matrix of dentine surfaces. It is typically presented in the form of a gel and consists of, e.g., edetate disodium (EDTA) and carboxymethylcellulose (CMC) with a neutral pH. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D8091031	HIBCC
Unit of Use	D8091030	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	2.5	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a Cool Dry Place