Simplicity Kit: Original 100-50

GUDID 00850194007534

Simplicity Kit: No Rinse Dental Adhesive System (Original)

APEX DENTAL MATERIALS INCORPORATED

Dentine bonding agent/set

• Primary Device ID: 00850194007534
• NIH Device Record Key: e5ee924e-6303-4499-94b7-3e9f77d3efca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simplicity Kit: Original
• Version Model Number: 1
• Catalog Number: 100-50
• 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	00850194007534 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020570

FDA Product Code

• 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: 3
• Public Version Date: 2018-07-06
• 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