Acrylic Block TS03US

GUDID 14560227799201

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system.　The size of the product is

SUN MEDICAL CO.,LTD.

Dental appliance fabrication material, thermoplastic

• Primary Device ID: 14560227799201
• NIH Device Record Key: eb354040-e33e-4cad-b281-571a597217e2
• Commercial Distribution Discontinuation: 2018-05-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Acrylic Block
• Version Model Number: MCL-011-A
• Catalog Number: TS03US
• Company DUNS: 690922612
• Company Name: SUN MEDICAL CO.,LTD.
• Device Count: 5
• 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: false
• 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 Dimensions

• Depth: 35 Millimeter
• Width: 109 Millimeter
• Length: 109 Millimeter
• Depth: 35 Millimeter
• Width: 109 Millimeter
• Length: 109 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560227799010 [Unit of Use]
GS1	14560227799201 [Primary]
GS1	24560227799324 [Package]; Package: Cardboard [4 Units]; Discontinued: 2018-05-01; Not in Commercial Distribution

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2018-05-24
• Device Publish Date: 2016-11-07

On-Brand Devices [Acrylic Block]

• 14560227799300: Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
• 14560227799294: Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
• 14560227799287: Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
• 14560227799270: Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
• 14560227799263: Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
• 14560227799256: Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
• 14560227799249: Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
• 14560227799232: Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
• 14560227799225: Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
• 14560227799218: Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
• 14560227799201: Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba
• 14560227799195: Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture ba