SPEEDEX

GUDID 07630243601233

SPEEDEX LB 140ML

Dent4You AG

Silicone dental impression material

• Primary Device ID: 07630243601233
• NIH Device Record Key: 049b34c6-72e2-4729-8821-c1085f007d47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPEEDEX
• Version Model Number: 4980
• Company DUNS: 480152811
• Company Name: Dent4You AG
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630243601233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242360

FDA Product Code

• ELW: Material, Impression

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: 2025-05-08
• Device Publish Date: 2025-04-30

On-Brand Devices [SPEEDEX]

• 07630243636013: SPEEDEX UNIV. ACT. SGL 60ML
• 07630243601745: SPEEDEX PUTTY SOFT
• 07630243601738: SPEEDEX MEDIUM SGL 140ML
• 07630243601721: SPEEDEX LB SGL 140ML
• 07630243601714: SPEEDEX PUTTY SGL 910ML
• 07630243601707: SPEEDEX TRIAL KIT
• 07630243601295: SPEEDEX PUTTY SOFT
• 07630243601264: SPEEDEX UNIV. ACT. 60ML
• 07630243601257: SPEEDEX MEDIUM 140ML
• 07630243601240: SPEEDEX PUTTY 910ML
• 07630243601233: SPEEDEX LB 140ML