FDA.reportPublic FDA data

Roydent

Primary DI
D809PL2081
Brand
Roydent
Company
ROYDENT DENTAL PRODUCTS INC
Model
PL208
Catalog number
PL208
Device description
ENDO CLEANSE 2oz. BOTTLE
Published
2016-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKLPOINT, SILVER, ENDODONTIC
KIFRESIN, ROOT CANAL FILLING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKLPoint, Silver, EndodonticDental1
KIFResin, Root Canal FillingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D809PL2081PrimaryHIBCC0

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 Volume2Fluid Ounce

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
1
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809518341252One-FilMEDICLUS CO.,LTDKIF2026-05-11
08809518343706One-Fil PuttyMEDICLUS CO.,LTDKIF2026-05-11
08404535015126Brasseler USAPeter Brasseler Holdings, LLCKIF2026-04-29
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07898078652961BIO-C REPAIR Angelus Industria de Produtos Odontologicos S AKIF2026-03-25
07290115050523BJM Root Canal SealerB.J.M. LABORATORIES LTDKIF2026-03-20
00195062152771ZenSeal ProKerr CorporationKIF2026-02-10
00850440008490Actacal Bioceramic SealerEngineered Endodontics, LLCKIF2026-01-02
08800123819730Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08800123819747Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08800123819754Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08809254459402Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08809254459419Well-Root PTVERICOM CO., LTD.KIF2025-11-27
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