MARK3

GUDID D79648881

Hybrid Composite B3 Unidose .25gm. 20/pk. - MARK3

CARGUS INTERNATIONAL, INC

Dental composite resin

• Primary Device ID: D79648881
• NIH Device Record Key: e5d148e7-73e1-46a4-ac85-96306c026b67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MARK3
• Version Model Number: 4888
• Company DUNS: 096191093
• Company Name: CARGUS INTERNATIONAL, INC
• Device Count: 20
• 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: true
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 74 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 74 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7964888 [Unit of Use]
HIBCC	D79648881 [Primary]

FDA Product Code

• EBF: Material, Tooth Shade, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-04-19

On-Brand Devices [MARK3]

• D79690921: Etchant Gel 37% Jumbo Kit 50ml. Syringe(1x50ml. Syr., 4x1.2ml. Empty Syr. & 50 Tips) - MARK3
• D79690911: Etchant Gel 37% Bulk Pack 25/bx. (25x1.2ml. Syr. & 50 Tips) - MARK3
• D79690901: Etchant Gel 37% 4/bx. (4x1.2ml Syr. & 20 Tips) - MARK3
• D79690101: Alginate Substitute Fast Set 50ml. Cartridges 8/pk. - MARK3
• D7967799CASE1: Digital Xray Sensor Sleeves #2 1-5/8"x8" 500pcs/bx - 36bxs/cs - MARK3
• D79677991: Digital Xray Sensor Sleeves #2 1-5/8"x8" 500/bx. - MARK3
• D7967798CASE1: Digital Xray Sensor Sleeves #1 1-3/8"x8" 500pcs/bx - 36bxs/cs - MARK3
• D79677981: Digital Xray Sensor Sleeves #1 1-3/8"x8" 500/bx. - MARK3
• D796710200: 5% Sodium Fluoride Varnish with TCP Caramel Unidose 50/bx. - MARK3
• D79671011: 5% Sodium Fluoride Varnish with TCP Spearmint Unidose 50/bx. - MARK3
• D79671001: 5% Sodium Fluoride Varnish with TCP Bubble Gum Unidose 50/bx. - MARK3
• D79648891: Hybrid Composite C2 Unidose .25gm. 20/pk. - MARK3
• D79648881: Hybrid Composite B3 Unidose .25gm. 20/pk. - MARK3
• D79648871: Hybrid Composite B2 Unidose .25gm. 20/pk. - MARK3
• D79648861: Hybrid Composite B1 Unidose .25gm. 20/pk. - MARK3
• D79648851: Hybrid Composite A4 Unidose .25gm. 20/pk. - MARK3
• D79648841: Hybrid Composite A3.5 Unidose .25gm. 20/pk. - MARK3
• D79648831: Hybrid Composite A3 Unidose .25gm. 20/pk. - MARK3
• D79648811: Hybrid Composite A1 Unidose .25gm. 20/pk. - MARK3
• D79641031: Temporary 10:1 Crown & Bridge A3 75gm. Cartridge & 10 Tips - MARK3
• D79641021: Temporary 10:1 Crown & Bridge A2 75gm. Cartridge & 10 Tips - MARK3
• D79641011: Temporary 10:1 Crown & Bridge A1 75gm. Cartridge & 10 Tips - MARK3
• D79641010: Temporary 10:1 Crown & Bridge A1 75gm. Cartridge & 10 Tips
• D79630261: VPS 380 Impression Material Monophase Regular Set 2/pk. - MARK3
• D79630251: VPS 380 Impression Material Heavy Body Regular Set 2/pk. - MARK3
• D7963017BULK1: VPS Impression Material Monophase Fast Set 50ml. Cartridges 100/cs. - MARK3
• D79630171: VPS Impression Material Monophase Fast Set 50ml. Cartridges 4/bx. - MARK3
• D7963016BULK1: VPS Impression Material Monophase Regular Set 50ml. Cartridges 100/cs. - MARK3
• D79630161: VPS Impression Material Monophase Regular Set 50ml. Cartridges 4/bx. - MARK3
• D7963015BULK1: VPS Impression Material Heavy Fast Set 50ml. Cartridges 100/cs. - MARK3
• D79630151: VPS Impression Material Heavy Fast Set 50ml. Cartridges 4/bx. - MARK3
• D7963014BULK1: VPS Impression Material Heavy Regular Set 50ml. Cartridges 100/cs. - MARK3
• D79630141: VPS Impression Material Heavy Regular Set 50ml. Cartridges 4/bx. - MARK3
• D7963013BULK1: VPS Impression Material Medium Fast Set 50ml. Cartridges 100/cs. - MARK3
• D79630131: VPS Impression Material Medium Fast Set 50ml. Cartridges 4/bx. - MARK3
• D7963012BULK1: VPS Impression Material Medium Regular 50ml. Cartridges Set 100/cs. - MARK3
• D79630121: VPS Impression Material Medium Regular 50ml. Cartridges Set 4/bx. - MARK3
• D7963011BULK1: VPS Impression Material Light Fast Set 50ml. Cartridges 100/cs. - MARK3
• D79630111: VPS Impression Material Light Fast Set 50ml. Cartridges 4/bx. - MARK3
• D7963010BULK1: VPS Impression Material Light Regular Set 50ml. Cartridges 100/cs. - MARK3
• D79630101: VPS Impression Material Light Regular Set 50ml. Cartridges 4/bx. - MARK3
• D79630051: VPS Putty Fast Set 300ml. each Base & Catalyst - MARK3
• D79630041: VPS Putty Regular Set 300ml. each Base & Catalyst - MARK3
• D79630001: VPS Tray Adhesive 10ml. - MARK3
• D7962127CASE1: T Style Handle Sleeves 4" x 5-3/4" 500pcs/bx - 60bxs/cs - MARK3
• D79621271: T Style Handle Sleeves 4" x 5-3/4" 500/bx. - MARK3
• D7962125CASE1: Full Chair Sleeves 29" x 80" 125pcs/bx - 3bxs/cs - MARK3
• D79621251: Full Chair Sleeves 29" x 80" 125/bx. - MARK3
• D7962124CASE1: Half Chair Covers 27-1/2" x 24" 225pcs/bx - 3bxs/cs - MARK3
• D79621241: Half Chair Covers 27-1/2" x 24" 225/bx. - MARK3