Access Crown

GUDID 00817051021294

Access Crown Ultra A2 temporary crown and bridge material, 50ml cartridge

CENTRIX, INC.

Dental crown/bridge resin, temporary

• Primary Device ID: 00817051021294
• NIH Device Record Key: f52b323c-befe-4ab3-8f62-0afd4a6d3729
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Crown
• Version Model Number: 360129
• Company DUNS: 053707303
• Company Name: CENTRIX, 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817051021294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040769

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Access Crown]

• 00817051021324: Access Crown A3 temporary crown and bridge material, 5ml syringe
• 00817051021317: Access Crown A2 temporary crown and bridge material, 5ml syringe
• 00817051021300: Access Crown Ultra A3 temporary crown and bridge material, 50ml cartridge
• 00817051021294: Access Crown Ultra A2 temporary crown and bridge material, 50ml cartridge
• 00817051021287: Access Crown Ultra A1 temporary crown and bridge material, 50ml cartridge
• 00817051021201: Access Crown BL temporary crown and bridge material, 50ml cartridge
• 00817051021195: Access Crown C2 temporary crown and bridge material, 50ml cartridge
• 00817051021188: Access Crown A1 temporary crown and bridge material, 50ml cartridge
• 00817051021171: Access Crown A2 temporary crown and bridge material, 50ml cartridge
• 00817051021164: Access Crown B3 temporary crown and bridge material, 50ml cartridge
• 00817051021157: Access Crown B1 temporary crown and bridge material, 50ml cartridge
• 00817051021140: Access Crown A3 temporary crown and bridge material, 50ml cartridge
• 00817051021133: Access Crown A3.5 temporary crown and bridge material, 50ml cartridge