SpeedCEM / SpeedCEM Plus 692422WW

GUDID 07615208480009

Speedcem Plus Refill 3x9g transp.

IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Dental composite resin

• Primary Device ID: 07615208480009
• NIH Device Record Key: 0c6d064a-b89b-42a5-8ea8-31ed38231b47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpeedCEM / SpeedCEM Plus
• Version Model Number: 692422WW
• Catalog Number: 692422WW
• Company DUNS: 448015938
• Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT
• Device Count: 3
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07615208293487 [Primary]
GS1	07615208480009 [Unit of Use]
HIBCC	DVIV692422WW1 [Previous]

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: 2024-10-22
• Device Publish Date: 2024-10-14

On-Brand Devices [SpeedCEM / SpeedCEM Plus]

• 07615208294972: Speedcem Plus Refill Yel. 9g
• 07615208294958: Speedcem Plus Refill transp. 9g
• 07615208480009: Speedcem Plus Refill 3x9g transp.
• 07615208480016: Speedcem Plus Refill 3x9g yellow