Seamless Single Syringe Pack with Tips

GUDID 00850194007947

Seamless Single Syringe Pack with Tips

APEX DENTAL MATERIALS INCORPORATED

Dental unfilled resin sealant/coating

• Primary Device ID: 00850194007947
• NIH Device Record Key: cac01d4d-d229-45a4-ac41-06fc5eacb162
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Seamless Single Syringe Pack with Tips
• Version Model Number: 1
• 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	00850194007947 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092539

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-12-13

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• 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