RIVA LUTING 8650510

GUDID 09336472017002

RIVA LUTING P/L TRIPLE PK

SDI LIMITED

Glass ionomer dental cement
Primary Device ID09336472017002
NIH Device Record Keyb72370f7-5274-4681-9401-6a96e02b6207
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIVA LUTING
Version Model Number8650510
Catalog Number8650510
Company DUNS753221852
Company NameSDI LIMITED
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F) for liquid refills and P/L kits. Powder refills can be stored at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F) for liquid refills and P/L kits. Powder refills can be stored at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F) for liquid refills and P/L kits. Powder refills can be stored at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F) for liquid refills and P/L kits. Powder refills can be stored at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F) for liquid refills and P/L kits. Powder refills can be stored at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F) for liquid refills and P/L kits. Powder refills can be stored at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F) for liquid refills and P/L kits. Powder refills can be stored at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F) for liquid refills and P/L kits. Powder refills can be stored at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F) for liquid refills and P/L kits. Powder refills can be stored at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F) for liquid refills and P/L kits. Powder refills can be stored at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F) for liquid refills and P/L kits. Powder refills can be stored at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F) for liquid refills and P/L kits. Powder refills can be stored at ambient temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Storage conditions < 25°C (< 77°F) for liquid refills and P/L kits. Powder refills can be stored at ambient temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS109336472017002 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-16
Device Publish Date2025-01-08

On-Brand Devices [RIVA LUTING]

DO3686519001RIVA LUTING PLUS LQD REF 10G
DO3686515081RIVA LUTING PLUS P/L KT
DO3686511081RIVA LUTING PLUS PWD REF 25G
DO3686510081RIVA LUTING PLUS 50 CAP
DO3686509001RIVA LUTING LQD REF 25G
DO3686505101RIVA LUTING P/L TRIPLE PK
DO3686505081RIVA LUTING P/L KT LARGE
DO3686501081RIVA LUTING LY PWD REF 35
DO3686500081RIVA LUTING LY 50 CAP
09336472017149RIVA LUTING PLUS P/L KT
09336472017118RIVA LUTING PLUS PWD REF 25G
09336472017071RIVA LUTING PLUS 50 CAP
09336472017002RIVA LUTING P/L TRIPLE PK
09336472016982RIVA LUTING P/L KT LARGE
09336472016937RIVA LUTING LY PWD REF 35
09336472016906RIVA LUTING LY 50 CAP

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