RE-GEN Bulk Fill Composite and Resin Cement Kit A4 90661

GUDID 00850194007510

RE-GEN Bulk Fill Composite and Resin Cement Kit A4

APEX DENTAL MATERIALS INCORPORATED

Dental composite resin

• Primary Device ID: 00850194007510
• NIH Device Record Key: ec9d451f-bda1-4c83-8fbe-b1a6534f3392
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RE-GEN Bulk Fill Composite and Resin Cement Kit A4
• Version Model Number: 1
• Catalog Number: 90661
• Company DUNS: 018651672
• Company Name: APEX DENTAL MATERIALS INCORPORATED
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850194007510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091647

FDA Product Code

• EBF: Material, Tooth Shade, Resin
• KLE: Agent, Tooth Bonding, 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: 2019-12-16
• Device Publish Date: 2016-06-16

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