RIVA LC 8730001

GUDID DO3687300011

SDI LIMITED

Glass ionomer dental cement
Primary Device IDDO3687300011
NIH Device Record Keye1ee69a3-5c47-4370-b571-1f5e9e3b2f8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIVA LC
Version Model NumberRIVA LC HV A1 50 CAP
Catalog Number8730001
Company DUNS753221852
Company NameSDI LIMITED
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18002285166
Emailinfo@sdi.com.au
Phone+18002285166
Emailinfo@sdi.com.au
Phone+18002285166
Emailinfo@sdi.com.au
Phone+18002285166
Emailinfo@sdi.com.au
Phone+18002285166
Emailinfo@sdi.com.au
Phone+18002285166
Emailinfo@sdi.com.au
Phone+18002285166
Emailinfo@sdi.com.au
Phone+18002285166
Emailinfo@sdi.com.au
Phone+18002285166
Emailinfo@sdi.com.au
Phone+18002285166
Emailinfo@sdi.com.au
Phone+18002285166
Emailinfo@sdi.com.au
Phone+18002285166
Emailinfo@sdi.com.au
Phone+18002285166
Emailinfo@sdi.com.au
Phone+18002285166
Emailinfo@sdi.com.au
Phone+18002285166
Emailinfo@sdi.com.au
Phone+18002285166
Emailinfo@sdi.com.au

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment Atmospheric PressureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment Atmospheric PressureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment Atmospheric PressureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment Atmospheric PressureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment Atmospheric PressureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment Atmospheric PressureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment Atmospheric PressureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment Atmospheric PressureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment Atmospheric PressureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment Atmospheric PressureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment Atmospheric PressureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment Atmospheric PressureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment Atmospheric PressureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment Atmospheric PressureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment Atmospheric PressureBetween 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCDO3687300010 [Unit of Use]
HIBCCDO3687300011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACEMENT, DENTAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-11

On-Brand Devices [RIVA LC]

DO3687300061RIVA LC HV B1 50 CAP
DO3687300041RIVA LC HV A3.5 50 CAP
DO3687300031RIVA LC HV A3 50 CAP
DO3687300021RIVA LC HV A2 50 CAP
DO3687300011RIVA LC HV A1 50 CAP
DO3687100021RIVA LC STARTER KT A2
DO3687100011RIVA LC STARTER KT A1
DO3687100001RIVA LC CAP ASSTD KT
DO3687009001RIVA LC LQD REF
DO3687005121RIVA LC C2 P/L KT
DO3687005071RIVA LC B2 P/L KT
DO3687005051RIVA LC A4 P/L KT
DO3687005041RIVA LC A3.5 P/L KT
DO3687005031RIVA LC A3 P/L KT
DO3687005021RIVA LC A2 P/L KT
DO3687005011RIVA LC A1 P/L KT
DO3687001161RIVA LC B PWD REF 15G
DO3687001141RIVA LC C4 PWD REF 15G
DO3687001121RIVA LC C2 PWD REF 15G
DO3687001081RIVA LC B3 PWD REF 15G
DO3687001071RIVA LC B2 PWD REF 15G
DO3687001041RIVA LC A3.5 PWD REF 15G
DO3687001031RIVA LC A3 PWD REF 15G
DO3687001021RIVA LC A2 PWD REF 15G
DO3687001011RIVA LC A1 PWD REF 15G
DO3687000161RIVA LC B 50 CAP
DO3687000141RIVA LC C4 50 CAP
DO3687000121RIVA LC C2 50 CAP
DO3687000101RIVA LC B4 50 CAP
DO3687000081RIVA LC B3 50 CAP
DO3687000071RIVA LC B2 50 CAP
DO3687000051RIVA LC A4 50 CAP
DO3687000041RIVA LC A3.5 50 CAP
DO3687000031RIVA LC A3 50 CAP
DO3687000021RIVA LC A2 50 CAP
DO3687000011RIVA LC A1 50 CAP
09336472018184RIVA LC HV B1 50 CAP
09336472018177RIVA LC HV A3.5 50 CAP
09336472018160RIVA LC HV A3 50 CAP
09336472018153RIVA LC HV A2 50 CAP
09336472018146RIVA LC HV A1 50 CAP
09336472018085RIVA LC CAP ASSTD KT
09336472018054RIVA LC LQD REF
09336472017781RIVA LC A3 P/L KT
09336472017774RIVA LC A2 P/L KT
09336472017767RIVA LC A1 P/L KT
09336472017606RIVA LC A3 PWD REF 15G
09336472017590RIVA LC A2 PWD REF 15G
09336472017484RIVA LC B 50 CAP
09336472017477RIVA LC C4 50 CAP
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