RIVA LC 8700012

GUDID 09336472017460

RIVA LC C2 50 CAP

SDI LIMITED

Glass ionomer dental cement

• Primary Device ID: 09336472017460
• NIH Device Record Key: c394492a-f562-4e1b-823c-551e9b2eb499
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIVA LC
• Version Model Number: 8700012
• Catalog Number: 8700012
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	09336472017460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050870

FDA Product Code

• EMA: CEMENT, DENTAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-16
• Device Publish Date: 2025-01-08

On-Brand Devices [RIVA LC]

• DO3687300061: RIVA LC HV B1 50 CAP
• DO3687300041: RIVA LC HV A3.5 50 CAP
• DO3687300031: RIVA LC HV A3 50 CAP
• DO3687300021: RIVA LC HV A2 50 CAP
• DO3687300011: RIVA LC HV A1 50 CAP
• DO3687100021: RIVA LC STARTER KT A2
• DO3687100011: RIVA LC STARTER KT A1
• DO3687100001: RIVA LC CAP ASSTD KT
• DO3687009001: RIVA LC LQD REF
• DO3687005121: RIVA LC C2 P/L KT
• DO3687005071: RIVA LC B2 P/L KT
• DO3687005051: RIVA LC A4 P/L KT
• DO3687005041: RIVA LC A3.5 P/L KT
• DO3687005031: RIVA LC A3 P/L KT
• DO3687005021: RIVA LC A2 P/L KT
• DO3687005011: RIVA LC A1 P/L KT
• DO3687001161: RIVA LC B PWD REF 15G
• DO3687001141: RIVA LC C4 PWD REF 15G
• DO3687001121: RIVA LC C2 PWD REF 15G
• DO3687001081: RIVA LC B3 PWD REF 15G
• DO3687001071: RIVA LC B2 PWD REF 15G
• DO3687001041: RIVA LC A3.5 PWD REF 15G
• DO3687001031: RIVA LC A3 PWD REF 15G
• DO3687001021: RIVA LC A2 PWD REF 15G
• DO3687001011: RIVA LC A1 PWD REF 15G
• DO3687000161: RIVA LC B 50 CAP
• DO3687000141: RIVA LC C4 50 CAP
• DO3687000121: RIVA LC C2 50 CAP
• DO3687000101: RIVA LC B4 50 CAP
• DO3687000081: RIVA LC B3 50 CAP
• DO3687000071: RIVA LC B2 50 CAP
• DO3687000051: RIVA LC A4 50 CAP
• DO3687000041: RIVA LC A3.5 50 CAP
• DO3687000031: RIVA LC A3 50 CAP
• DO3687000021: RIVA LC A2 50 CAP
• DO3687000011: RIVA LC A1 50 CAP
• 09336472018184: RIVA LC HV B1 50 CAP
• 09336472018177: RIVA LC HV A3.5 50 CAP
• 09336472018160: RIVA LC HV A3 50 CAP
• 09336472018153: RIVA LC HV A2 50 CAP
• 09336472018146: RIVA LC HV A1 50 CAP
• 09336472018085: RIVA LC CAP ASSTD KT
• 09336472018054: RIVA LC LQD REF
• 09336472017781: RIVA LC A3 P/L KT
• 09336472017774: RIVA LC A2 P/L KT
• 09336472017767: RIVA LC A1 P/L KT
• 09336472017606: RIVA LC A3 PWD REF 15G
• 09336472017590: RIVA LC A2 PWD REF 15G
• 09336472017484: RIVA LC B 50 CAP
• 09336472017477: RIVA LC C4 50 CAP