PD ADMIX 4000006

GUDID D662070830281

PD ADMIX 2SP REG 50

SDI LIMITED

Dental amalgam alloy

• Primary Device ID: D662070830281
• NIH Device Record Key: 79b72e95-bd26-46f1-b311-32b65451d571
• Commercial Distribution Discontinuation: 2026-02-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PD ADMIX
• Version Model Number: 4000006
• Catalog Number: 4000006
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D662070830281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973086

FDA Product Code

• EJJ: Alloy, Amalgam

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: 2026-02-25
• Device Publish Date: 2026-02-17

On-Brand Devices [PD ADMIX]

• D662070830281: PD ADMIX 2SP REG 50
• D662070830273: PD ADMIX 2SP FAST 50
• D662070830166: PD ADMIX 2SP REG 500
• D662070830158: PD ADMIX 2SP FAST 500