PATTERN RESIN™ LS 335201

GUDID D6583352011

PATTERN RESIN™ LS 1-1 Pack (1 x 100g powder, 1 x 105mL liquid, 2 x mixing cups, 1 x brush No. 4 & 1 x pipette)

Gc America Inc.

Dental acrylic resin

• Primary Device ID: D6583352011
• NIH Device Record Key: 293a3c7a-85d3-4e36-a4c9-c4396090d4a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PATTERN RESIN™ LS
• Version Model Number: 335201
• Catalog Number: 335201
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• 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: 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(708)597-0900
• Email: customerservice@gcamerica.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D6583352011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942670

FDA Product Code

• EBG: CROWN AND BRIDGE, TEMPORARY, 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: 4
• Public Version Date: 2019-12-13
• Device Publish Date: 2016-08-01

On-Brand Devices [PATTERN RESIN™ LS]

• D6583352051: PATTERN RESIN™ LS 262mL liquid
• D6583352041: PATTERN RESIN™ LS 1kg powder
• D6583352031: PATTERN RESIN™ LS 105mL liquid
• D6583352021: PATTERN RESIN™ LS 100g powder
• D6583352011: PATTERN RESIN™ LS 1-1 Pack (1 x 100g powder, 1 x 105mL liquid, 2 x mixing cups, 1 x brush No.
• D6583352091: Pattern Resin LS Mini Powder Refill 30g
• D6583352081: PATTERN RESIN LS Mini Liquid Refill 30ml
• D6583352071: PATTERN RESIN LS 1:1 Package Mini
• 10386040006682: PATTERN RESIN™ LS 1kg powder
• 10386040003414: PATTERN RESIN™ LS 262mL liquid
• 10386040001045: PATTERN RESIN™ LS 105mL liquid
• 10386040001038: PATTERN RESIN™ LS 100g powder
• 10386040000949: PATTERN RESIN™ LS 1-1 Pack (1 x 100g powder, 1 x 105mL liquid, 2 x mixing cups, 1 x brush No.