SpeedCEM / SpeedCEM Plus 681712WW

GUDID 07615208294958

Speedcem Plus Refill transp. 9g

IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Dental composite resin

• Primary Device ID: 07615208294958
• NIH Device Record Key: 7ba72789-b141-4461-bb68-8ece461a932f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpeedCEM / SpeedCEM Plus
• Version Model Number: 681712WW
• Catalog Number: 681712WW
• Company DUNS: 448015938
• Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT
• 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: 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	07615208294958 [Primary]
HIBCC	DVIV681712WW1 [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