Roydent PL209

GUDID D809PL2091

ENDO-CLEANSE 8oz. BOTTLE

ROYDENT DENTAL PRODUCTS INC

Dental root surface conditioner Dental root surface conditioner
Primary Device IDD809PL2091
NIH Device Record Key392706f7-cdc9-40ac-ae07-dd0e0aa2620e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRoydent
Version Model NumberPL209
Catalog NumberPL209
Company DUNS131487225
Company NameROYDENT DENTAL PRODUCTS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)992-7767
Emailinfo@roydent.com
Phone+1(800)992-7767
Emailinfo@roydent.com

Device Dimensions

Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a Cool Dry Place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a Cool Dry Place

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD809PL2091 [Primary]

FDA Product Code

EKLPOINT, SILVER, ENDODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-12
Device Publish Date2016-10-07

On-Brand Devices [Roydent]

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D8097601TO DYE FOR
D8097091CHEMLOCK MINI KIT
D8097031EDTA (28 PKG)
D8097021CHEMLOCK BONDING ENHANCER
D8097011CHEMLOCK CEMENT
D8095031REFORM TEMP. C&B MATERIAL B1
D8095021REFORM TEMP. C&B MATERIAL A3.5
D8095011REFORM TEMP. C&B MATERIAL A2
D8095001REFORM TEMP. C&B MATERIAL A1
D809205STD1BOSTON POSTS CEMENT STD.
D8091031C.L. CANAL LUBRICANT (20 COUNT
D809102502R12Seal Easymix Tips Refill
D809102501R12Seal Easymix Syringe Refill
D8091011C.L. CANAL LUBRICANT (150)

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