LC Block-Out 241

GUDID 00883205103352

LC Block-Out Resin Refill

ULTRADENT PRODUCTS, INC.

Dental articulation paste/solution

• Primary Device ID: 00883205103352
• NIH Device Record Key: f832d44b-4aa9-4e0c-9539-8d74a94a42c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LC Block-Out
• Version Model Number: 241
• Catalog Number: 241
• Company DUNS: 013369913
• Company Name: ULTRADENT PRODUCTS, INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205103352 [Primary]

FDA Product Code

• EBH: MATERIAL, IMPRESSION TRAY, RESIN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-23
• Device Publish Date: 2017-09-20

On-Brand Devices [LC Block-Out]

• 00883205103369: LC Block-Out Resin Kit
• 00883205103352: LC Block-Out Resin Refill
• 00883205103345: LC Block-Out Resin Econo Refill