RE-GEN Universal Adhesive Kit 90637

GUDID 00850194007473

RE-GEN Universal Adhesive Kit

APEX DENTAL MATERIALS INCORPORATED

Dentine bonding agent/set

• Primary Device ID: 00850194007473
• NIH Device Record Key: e1d3bdf4-1b48-4967-ab39-cbe6b11b45c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RE-GEN Universal Adhesive Kit
• Version Model Number: 1
• Catalog Number: 90637
• 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	00850194007473 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131043

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

Devices Manufactured by APEX DENTAL MATERIALS INCORPORATED

• 00850194007787 - Purify+ Gel 5 Pack: 2019-12-23 Purify+ Gel 5 Pack
• 00850194007794 - Purify+ Liquid 5 Pack: 2019-12-23 Purify+ Liquid 5 Pack
• 00850194007800 - VistaCORE 5ml Syringe Shade A2: 2019-12-23 VistaCORE 5ml Syringe Shade A2
• 00850194007817 - VistaCORE 5ml Syringe Shade White Opaque: 2019-12-23 VistaCORE 5ml Syringe Shade White Opaque
• 00850194007824 - VistaCORE 25ml Cartridge Shade White Opaque: 2019-12-23 VistaCORE 25ml Cartridge Shade White Opaque
• 00850194007831 - VistaCORE 25ml Cartridge Shade A2: 2019-12-23 VistaCORE 25ml Cartridge Shade A2
• 00850194007848 - VistaCORE 25ml Cartridge Kit Shade A2: 2019-12-23 VistaCORE 25ml Cartridge Kit Shade A2
• 00850194007855 - VistaCORE 25ml Cartridge Kit Shade White Opaque: 2019-12-23 VistaCORE 25ml Cartridge Kit Shade White Opaque