FDA.reportPublic FDA data

Roydent

Primary DI
D8091011
Brand
Roydent
Company
ROYDENT DENTAL PRODUCTS INC
Model
101
Catalog number
101
Device description
C.L. CANAL LUBRICANT (150)
Published
2016-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKLPOINT, SILVER, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKLPoint, Silver, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8091011PrimaryHIBCC0
D8091010Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental root surface conditionerA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume2.5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a Cool Dry Place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)992-7767info@roydent.com

Regulatory Flags#

DUNS number
131487225
Device count
150
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D80906319015R1Endodontic Hand Instruments06319015R06319015R2022-11-29
D80906319015R0Endodontic Hand Instruments06319015R06319015R2022-11-29
D80906319010R1Endodontic Hand Instruments06319010R06319010R2022-11-10
D80906319010R0Endodontic Hand Instruments06319010R06319010R2022-11-10
D80906319020R1Endodontic Hand Instruments06319020R06319020R2022-11-09
D80906319025R1Endodontic Hand Instruments06319025R06319025R2022-11-09
D80906319160R1Endodontic Hand Instruments06319160R06319160R2022-11-09
D80906321006R1Endodontic Hand Instruments06321006R06321006R2022-11-09
D80906321008R1Endodontic Hand Instruments06321008R06321008R2022-11-09
D80906321010R1Endodontic Hand Instruments06321010R06321010R2022-11-09
D80906321012R1Endodontic Hand Instruments06321012R06321012R2022-11-09
D80906321015R1Endodontic Hand Instruments06321015R06321015R2022-11-09
D80906321017R1Endodontic Hand Instruments06321017R06321017R2022-11-09
D80906321020R1Endodontic Hand Instruments06321020R06321020R2022-11-09
D80906321025R1Endodontic Hand Instruments06321025R06321025R2022-11-09
D80906321030R1Endodontic Hand Instruments06321030R06321030R2022-11-09
D80906321035R1Endodontic Hand Instruments06321035R06321035R2022-11-09
D80906321040R1Endodontic Hand Instruments06321040R06321040R2022-11-09
D80906321045R1Endodontic Hand Instruments06321045R06321045R2022-11-09
D80906321050R1Endodontic Hand Instruments06321050R06321050R2022-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858395006097Sonendo 17% EDTASONENDO, INC.EKL2017-02-08
D8091031RoydentROYDENT DENTAL PRODUCTS INCEKL2016-10-07
D8097031RoydentROYDENT DENTAL PRODUCTS INCEKL2016-10-07
D809PL2081RoydentROYDENT DENTAL PRODUCTS INCEKL2016-10-07
D809PL2091RoydentROYDENT DENTAL PRODUCTS INCEKL2016-10-07
D701FILE2FILE-RITE™ PULPDENT CORPORATIONEKL2016-08-11
D701EDTA1202EDTA SOLUTION, 17%PULPDENT CORPORATIONEKL2016-07-21
D701EDTA302EDTA SOLUTION, 17%PULPDENT CORPORATIONEKL2016-07-21
D701EDTA4802EDTA SOLUTION, 17%PULPDENT CORPORATIONEKL2016-07-21
D701EDTA602EDTA SOLUTION, 17%PULPDENT CORPORATIONEKL2016-07-21