Premier Spreader

GUDID 00348783009491

SPREADER SE RC D 11

PREMIER DENTAL PRODUCTS COMPANY

Manual endodontic filling material spreader

• Primary Device ID: 00348783009491
• NIH Device Record Key: 929d649a-4803-411b-aba7-cb648eef05e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premier Spreader
• Version Model Number: 1003879
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	00348783009491 [Primary]

FDA Product Code

• EKK: Spreader, Pulp Canal Filling Material, Endodontic

Sterilization

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

[00348783009491]

Moist Heat or Steam Sterilization

[00348783009491]

Moist Heat or Steam Sterilization

[00348783009491]

Moist Heat or Steam Sterilization

[00348783009491]

Moist Heat or Steam Sterilization

[00348783009491]

Moist Heat or Steam Sterilization

[00348783009491]

Moist Heat or Steam Sterilization

[00348783009491]

Moist Heat or Steam Sterilization

[00348783009491]

Moist Heat or Steam Sterilization

[00348783009491]

Moist Heat or Steam Sterilization

[00348783009491]

Moist Heat or Steam Sterilization

[00348783009491]

Moist Heat or Steam Sterilization

[00348783009491]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-25
• Device Publish Date: 2026-03-17

On-Brand Devices [Premier Spreader]

• 00348783009491: SPREADER SE RC D 11
• 00348783009477: SPREADER SE RC D 11 T